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CompletedNCT00363311Updated Jan 18, 2017Results posted

Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men

A Phase 4 interventional study of Dutasteride and Matching placebo in Neoplasms, Prostate, sponsored by GlaxoSmithKline. Completed at 82 sites in 2 countries. Open to male participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-01-18.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
302
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
Male
01

Study summary

The purpose of this study is to examine the effect of dutasteride on the inhibition of low-risk, localized prostate cancer progression in men who would otherwise receive no active therapy (expectant management).

02

Conditions studied

  • Neoplasms, Prostate

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Keywords

  • Dutasteride Prostate Cancer Expectant management REDEEM
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 302 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Must be male ≥48 and ≤82 years of age
  • Have biopsy proven, low-risk, localized prostate cancer and active in expectant management not more than 14 months. [For the purposes of assessing subject eligibility a diagnostic biopsy must have included at least 10 cores, (\< 4 cores positive and \<50% of any one core positive) and must have been obtained within 8 months of screening]. If a saturation biopsy was performed (20 or more cores obtained) 2-3 cores are to be positive for prostate cancer and with \<50% of any one core positive. Initial diagnosis of T1a/T1b obtained during a Transrectal ultrasound (TURP) is not allowed.
  • Gleason score ≤6 [Gleason pattern 4 or above must not be present on any biopsy (initial or entry)]
  • Clinical stage T1c-T2a
  • Serum Prostate Specific Antigen (PSA) ≤11ng/mL. If the screening PSA value from the central laboratory is greater than 11ng/ml, one PSA retest is allowed through the central laboratory
  • A life expectancy greater than five years.
  • Able to swallow and retain oral medication
  • Able and willing to participate in the full 3 years of the study
  • Able to read and write (health outcomes questionnaires are self-administered), understand instructions related to study procedures and give written informed consent.

Exclusion criteria

Exclusion criteria:

  • Subject has ever been treated for prostate cancer with any of the following:
  • Radiotherapy (external beam or brachytherapy)
  • Chemotherapy
  • Hormonal therapy (e.g., megestrol, medroxyprogesterone, cyproterone, diethylstilbestrol (DES)
  • Oral glucocorticoids
  • Gonadotropin-releasing hormone (GnRH) analogues (e.g., leuprolide, goserelin)
  • Glucocorticoids, except inhaled or topical, are not permitted within 3 months prior to visit one
  • Current and/or previous use of the following medications:
  • Finasteride (Proscar, Propecia), or Dutasteride (GI198745, AVODART) exposure within 6 months prior to study entry are excluded.
  • Any other investigational 5α-reductase inhibitors within the past 12 months.
  • Anabolic steroids (subject must discontinued for 6 months prior to study entry to be eligible)

  • Drugs with antiandrogenic properties within the past 6 months (e.g,. spironolactone, flutamide, bicalutamide, *cimetidine, *ketoconazole, metronidazole, progestational agents) NOTE: Use of dietary and herbal supplements (e.g., selenium, Vitamin E, saw palmetto) during the study is discouraged but not prohibited. All dietary and herbal supplement usage will be recorded in the case report form (CRF).

    *The use of cimetidine is permitted prior to study entry. The use of topical ketoconazole is permitted prior to and during the study.

  • Prostate volume >80 cc
  • Subject has had prior prostatic surgery including Transurethral needle ablation of the prostate (TUNA), TURP, Transurethral incision of the prostate (TUIP), laser treatment, thermotherapy, balloon dilatation, prosthesis, and ultrasound ablation within 3 months of enrolment
  • Severe Benign Prostatic Hyperplasia (BPH) symptoms as manifested by International Prostate Symptom Score (IPSS) symptom score (calculated using the first 7 questions only) of ≥25 or >20 if already on alpha blocker therapy.
  • Participation in any investigational or marketed drug trial within the 30 days prior to the first dose of study drug or anytime during the study period.
  • Any unstable serious co-existing medical condition(s) including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
  • Abnormal liver function test (greater than 2 times the upper limit of normal for alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline phosphatase [ALP]); or bilirubin >1.5 times the upper limit of normal.
  • Serum creatinine >1.5 times the upper limit of normal.
  • History of another malignancy within five years that could affect the diagnosis of prostate cancer.
  • History or current evidence of drug or alcohol abuse within the last 12 months.
  • History of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject.
  • Known hypersensitivity to any 5α-reductase inhibitor or to any drug chemically related to dutasteride.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
302 participants (actual)

Study arms

  • Active comparator
    Dutasteride

    Dutasteride 0.5mg

    Drug: Dutasteride

  • Placebo comparator
    Placebo

    Matching placebo

    Drug: Matching placebo

Interventions

  • DrugDutasteride

    Dutasteride 0.5mg

  • DrugMatching placebo

    Matching placebo

06

What researchers measure

Primary outcomes

  1. Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression

    PC progression (prog.) was defined as the earliest occurrence of primary therapy, also referred to as therapeutic prog., for PC (prostatectomy/radiation/hormonal therapy); or pathological prog., defined as 1 of the following: \>=4 cores involved; \>=50% of any 1 core involved; or a Gleason pattern of \>=4 as a result of any on-study/for-cause biopsy. Primary Gleason grade is assigned to the most common tumor pattern; a second grade to the next most common tumor pattern. The two grades are added together to get a score. Gleason grade= 1-5; Gleason score=2-10; 5 and 10 indicate worst prognosis.

    Time frame: Year 1.5 and Overall (Years 0-3)

Secondary outcomes

  1. Number of Participants With Therapeutic Progression

    Primary therapy, also referred to as therapeutic progression, for prostate cancer can be one of the following: prostatectomy, radiation, or hormonal therapy.

    Time frame: Year 1.5 and Overall (Years 0-3)

  2. Number of Participants With Pathologic Progression

    Pathological progression is defined as one of the following: \>=4 cores involved; \>=50% of any 1 core involved; or a Gleason pattern of \>=4 as a result of any on-study/for-cause biopsy. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) were used to grade tumors. A primary grade is assigned to the most common tumor pattern, and a second grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade=1-5, with 5 having the worst prognosis. The Gleason score=2-10, with 10 having the worst prognosis.

    Time frame: Year 1.5 and Overall (Years 0-3)

  3. Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis

    All participants were required by protocol to undergo a transrectal ultrasound (TRUS)-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. All biopsies were reviewed and analyzed by a central pathologist.

    Time frame: Baseline to Month 18

  4. Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy

    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.

    Time frame: Years 0-3

  5. Number of Cancer-positive Cores in a 12-core Biopsy

    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. . The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.

    Time frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)

  6. Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3

    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Change from baseline was calculated as the number of cancer-positive cores at post-baseline biopsy minus the number of cancer-positive cores at baseline.

    Time frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)

  7. Mean Percentage of Cancer-positive Cores in a 12-core Biopsy

    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsies (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. The sum of cancer positive cores and the sum of evaluated cores were used to compute the percentage (100\* number of positive cores/number of evaluated cores).

    Time frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)

  8. Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3

    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. (100 \* number of positive cores/number of evaluated cores).

    Time frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)

  9. Cumulative Length of Cancer Tumor Core

    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Tumor length is calculated as the number of cores (12) \* total tumor length/number of evaluated cores.

    Time frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)

  10. Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3

    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist.

    Time frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)

  11. Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5

    The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS\<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS \>6).

    Time frame: Year 1.5

  12. Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3

    The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS\<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS \>6).

    Time frame: Years 0-3 (Final Biopsy)

  13. Number of Participants With the Indicated Total Gleason Score

    All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade the tumor. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a secondary grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade ranges from 1 to 5, with 5 having the worst prognosis. The Gleason score ranges from 2 to 10, with 10 having the worst prognosis.

    Time frame: Years 0-3 (Final Biopsy)

  14. Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline

    All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for clinical tumor staging were used. T1c = tumor identified by needle biopsy (e.g., because of elevated prostate-specific antigen \[PSA\]); T2 = tumor confined within the prostate; T2a = tumor involves one-half of one lobe, but not both lobes of the prostate.

    Time frame: Baseline

  15. Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage

    All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The National Comprehensive Network (NCCN), 2005 clinical practices guidelines in Oncology-prostate cancer were used for clinical tumor staging. T0: no evidence of primary tumor; T1: clinically inapparent tumor, neither palpable nor visible by imaging; T2: tumor confined within the prostate; T3: tumor extends through the prostate capsule; T4: tumor is fixed or invades adjacent structures other than seminal vesicles. A clinical stage of T0 in post-baseline biopsies has been interpreted as "No Worsening."

    Time frame: Months 0-18

  16. Prostate Volume (PV) LOCF

    Prostate volume was determined at baseline, at Year 1.5, and at Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula: π/ 6 (anteroposterior width \* cephalocaudal width \* transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements.

    Time frame: Baseline and Years 1.5 and 3

  17. Change From Baseline in Prostate Volume at Years 1.5 and 3

    Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula: π/ 6 (anteroposterior width \* cephalocaudal width \* transverse width). Prostate volume calculated by pre-programmed equipment was unacceptable for the on-study prostate volume measurements.

    Time frame: Baseline and Years 1.5 and 3

  18. Percent Change From Baseline in Prostate Volume at Years 1.5 and 3

    Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula: π/ 6 (anteroposterior width \* cephalocaudal width \* transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements.

    Time frame: Baseline and Years 1.5 and 3

  19. Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)

    The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.

    Time frame: Baseline and Month 3, 6, 12, 18, and 36

  20. Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF

    The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.

    Time frame: Baseline and Months 3, 6, 12, 18, and 36

  21. Total MAX-PC Anxiety Subscale Score Related to PSA Testing

    The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; "I have been so anxious about my PSA test that I have thought about delaying it.", "I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test.", "I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate." A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9.

    Time frame: Baseline and Months 3, 6, 12, 18, and 36

  22. Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)

    The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; "I have been so anxious about my PSA test that I have thought about delaying it.", "I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test.", "I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate." A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9.

    Time frame: Baseline and Months 3, 6, 12, 18, and 36

  23. Total MAX-PC Fear of Recurrence Subscale Score

    The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; "Because cancer is unpredictable, I feel I cannot plan for the future.", "My fear of having my cancer getting worse gets in the way of my enjoying life.", "I am afraid of my cancer getting worse.", "I am more nervous since I was diagnosed with prostate cancer." A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12.

    Time frame: Baseline and Months 3, 6, 12, 18, and 36

  24. Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)

    The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; "Because cancer is unpredictable, I feel I cannot plan for the future.", "My fear of having my cancer getting worse gets in the way of my enjoying life.", "I am afraid of my cancer getting worse.", "I am more nervous since I was diagnosed with prostate cancer." A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12.

    Time frame: Baseline and Months 3, 6, 12, 18, and 36

  25. Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score

    The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better quality of life.

    Time frame: Baseline and Months 18 and 36

  26. Change From Baseline in Total FACT-P Score (LOCF)

    The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.

    Time frame: Baseline and Months 18 and 36

  27. Percent Change From Baseline in Total FACT-P Score (LOCF)

    The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.

    Time frame: Baseline and Months 18 and 36

  28. Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF)

    The FACT-P Physical Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; "I have a lack of energy.", "I have nausea.", "Because of my physical condition, I have trouble meeting the needs of my family.", "I have pain.", "I am bothered by side effects of treatment.", "I feel ill.", "I am forced to spend time in bed." The score for each question ranges from 0 to 4; a lower score indicates better physical well-being. The total FACT-P score thus ranges from 0 to156; a higher score indicates a better quality of life.

    Time frame: Baseline and Months 18 and 36

  29. Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF)

    The FACT-P Social Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; "I feel close to my friends.", "I get emotional support from my family.", "I get support from my friends.", "My family has accepted my illness.", "I am satisfied with family communication about my illness.", "I feel close to my partner (or the person who is my main support).", "I am satisfied with my sex life." The score for each question ranges from 0 to 4; a higher score indicates better social well-being. The total FACT-P score thus ranges from 0 to 156.

    Time frame: Baseline and Months 18 and 36

07

Results

Posted Jun 14, 2011

Participant flow

Participant flow — Overall Study
MilestoneMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Started155147
Completed79102
Not completed7645
Withdrew: Adverse event64
Withdrew: Lost to follow-up30
Withdrew: Protocol violation12
Withdrew: Withdrawal by subject126
Withdrew: Physician decision11
Withdrew: Sponsor terminated study22
Withdrew: Disease progression4626
Withdrew: Non-compliance11
Withdrew: Participant refused biopsy10
Withdrew: Prostate volume/psa doubled10
Withdrew: Participant opted for treatment10
Withdrew: Participant moved to another country10
Withdrew: Participant withdrew waiting for surgery01
Withdrew: Withdrawn per instructions of monitor01
Withdrew: Participant moved to louisiana01

Outcome measures

PrimaryNumber of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression

PC progression (prog.) was defined as the earliest occurrence of primary therapy, also referred to as therapeutic prog., for PC (prostatectomy/radiation/hormonal therapy); or pathological prog., defined as 1 of the following: \>=4 cores involved; \>=50% of any 1 core involved; or a Gleason pattern of \>=4 as a result of any on-study/for-cause biopsy. Primary Gleason grade is assigned to the most common tumor pattern; a second grade to the next most common tumor pattern. The two grades are added together to get a score. Gleason grade= 1-5; Gleason score=2-10; 5 and 10 indicate worst prognosis.

Time frame:
Year 1.5 and Overall (Years 0-3)
Reported as:
Number · participants
Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression
participantsMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Year 1.5, n=144, 1425032
Overall (Years 0-3), n= 155, 1477154
Statistical analysis
  • Matching Placebo 0.5 mg Once Daily vs Dutasteride 0.5 mg Once Daily · Log Rank · p = 0.009 (Statistical data are for Year 1.5) · Relative risk estimate: 0.56 · 95% CI 0.36 to 0.87
  • Matching Placebo 0.5 mg Once Daily vs Dutasteride 0.5 mg Once Daily · Log Rank · p = 0.007 (Statistical data are for Overall (Years 0-3)) · Relative risk estimate: 0.61 · 95% CI 0.43 to 0.88
SecondaryNumber of Participants With Therapeutic Progression

Primary therapy, also referred to as therapeutic progression, for prostate cancer can be one of the following: prostatectomy, radiation, or hormonal therapy.

Time frame:
Year 1.5 and Overall (Years 0-3)
Reported as:
Number · participants
Number of Participants With Therapeutic Progression
participantsMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Year 1.5115
Overall (Years 0-3)2011
Statistical analysis
  • Matching Placebo 0.5 mg Once Daily vs Dutasteride 0.5 mg Once Daily · Log Rank · p = 0.13 (Statistical data are for Year 1.5) · Relative risk estimate: 0.46 · 95% CI 0.16 to 1.31
  • Matching Placebo 0.5 mg Once Daily vs Dutasteride 0.5 mg Once Daily · Log Rank · p = 0.053 (Statistical data are for Overall (Years 0-3)) · Relative risk estimate: 0.48 · 95% CI 0.22 to 1.03
SecondaryNumber of Participants With Pathologic Progression

Pathological progression is defined as one of the following: \>=4 cores involved; \>=50% of any 1 core involved; or a Gleason pattern of \>=4 as a result of any on-study/for-cause biopsy. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) were used to grade tumors. A primary grade is assigned to the most common tumor pattern, and a second grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade=1-5, with 5 having the worst prognosis. The Gleason score=2-10, with 10 having the worst prognosis.

Time frame:
Year 1.5 and Overall (Years 0-3)
Reported as:
Number · participants
Number of Participants With Pathologic Progression
participantsMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Year 1.5, n= 136, 1393927
Overall (Years 0-3) n=136, 1405143
Statistical analysis
  • Matching Placebo 0.5 mg Once Daily vs Dutasteride 0.5 mg Once Daily · Log Rank · p = 0.031 (Statistical data are for Year 1.5) · Relative risk estimate: 0.59 · 95% CI 0.36 to 0.96
  • Matching Placebo 0.5 mg Once Daily vs Dutasteride 0.5 mg Once Daily · Log Rank · p = 0.079 (Statistical data are for Overall (Years 0-3)) · Relative risk estimate: 0.70 · 95% CI 0.46 to 1.05
SecondaryParticipants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis

All participants were required by protocol to undergo a transrectal ultrasound (TRUS)-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. All biopsies were reviewed and analyzed by a central pathologist.

Time frame:
Baseline to Month 18
Reported as:
Number · participants
Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis
participantsMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Participants with a PCa diagnosis111111
Participants with no PCa diagnosis2529
Statistical analysis
  • Matching Placebo 0.5 mg Once Daily vs Dutasteride 0.5 mg Once Daily · Fisher Exact · p = 0.65
SecondaryParticipants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy

All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.

Time frame:
Years 0-3
Reported as:
Number · participants
Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy
participantsMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Participants with a PCa diagnosis10590
Participants with no PCa diagnosis3150
Statistical analysis
  • Matching Placebo 0.5 mg Once Daily vs Dutasteride 0.5 mg Once Daily · Fisher Exact · p = 0.024
SecondaryNumber of Cancer-positive Cores in a 12-core Biopsy

All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. . The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.

Time frame:
Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Reported as:
Mean · cores
Number of Cancer-positive Cores in a 12-core Biopsy
coresMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Baseline, n=155, 1471.6 ± 0.741.6 ± 0.72
Year 1.5, n=87, 992.8 ± 1.822.2 ± 1.25
Year 3, n=52, 542.0 ± 1.172.0 ± 0.95
Years 0-3 (Final biopsy), n=105, 903.0 ± 2.032.5 ± 1.25
SecondaryChange From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3

All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Change from baseline was calculated as the number of cancer-positive cores at post-baseline biopsy minus the number of cancer-positive cores at baseline.

Time frame:
Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Reported as:
Mean · cores
Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3
coresMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Year 1.5, n= 87, 991.1 ± 1.630.6 ± 1.36
Year 3, n=52, 542.0 ± 1.172.0 ± 0.95
Years 0-3 (Final biopsy), n=105, 903.0 ± 2.032.5 ± 1.25
SecondaryMean Percentage of Cancer-positive Cores in a 12-core Biopsy

All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsies (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. The sum of cancer positive cores and the sum of evaluated cores were used to compute the percentage (100\* number of positive cores/number of evaluated cores).

Time frame:
Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Reported as:
Mean · percentage of cores
Mean Percentage of Cancer-positive Cores in a 12-core Biopsy
percentage of coresMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Baseline, n= 155, 14714.3 ± 7.3014.5 ± 6.95
Year 1.5, n=87, 9923.7 ± 15.7619.0 ± 10.66
Year 3, n=52, 5416.5 ± 9.7117.3 ± 8.44
Years 0-3 (Final biopsy), n=105, 9024.7 ± 15.6621.7 ± 10.76
SecondaryChange From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3

All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. (100 \* number of positive cores/number of evaluated cores).

Time frame:
Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Reported as:
Mean · percentage of cores
Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3
percentage of coresMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Year 1.5, n= 87, 998.4 ± 13.733.7 ± 11.97
Year 3, n=52, 544.1 ± 9.841.5 ± 10.03
Years 0-3 (Final biopsy), n=105, 9010.0 ± 13.886.0 ± 11.40
SecondaryCumulative Length of Cancer Tumor Core

All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Tumor length is calculated as the number of cores (12) \* total tumor length/number of evaluated cores.

Time frame:
Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Reported as:
Mean · millimeters
Cumulative Length of Cancer Tumor Core
millimetersMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Baseline, n= 155, 1472.0 ± 1.862.1 ± 2.04
Year 1.5, n=87, 996.2 ± 5.994.8 ± 6.34
Year 3, n=52, 543.7 ± 3.823.8 ± 3.51
Years 0-3 (Final biopsy), n=105, 907.0 ± 7.026.1 ± 6.19
SecondaryChange From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3

All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist.

Time frame:
Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Reported as:
Mean · millimeters
Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3
millimetersMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Year 1.5, n= 87, 993.9 ± 5.712.5 ± 6.59
Year 3, n=52, 541.8 ± 3.941.5 ± 3.58
Years 0-3 (Final biopsy), n=105, 904.8 ± 6.703.8 ± 6.27
SecondaryNumber of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5

The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS\<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS \>6).

Time frame:
Year 1.5
Reported as:
Number · participants
Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5
participantsMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Improvement621
No change5158
Worsening2421
Statistical analysis
  • Matching Placebo 0.5 mg Once Daily vs Dutasteride 0.5 mg Once Daily · Wilcoxon (Mann-Whitney) · p = 0.20
SecondaryNumber of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3

The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS\<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS \>6).

Time frame:
Years 0-3 (Final Biopsy)
Reported as:
Number · participants
Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3
participantsMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Improvement3150
No cancer, GS 03150
No change8371
Worsening2219
Statistical analysis
  • Matching Placebo 0.5 mg Once Daily vs Dutasteride 0.5 mg Once Daily · Wilcoxon (Mann-Whitney) · p = 0.039
SecondaryNumber of Participants With the Indicated Total Gleason Score

All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade the tumor. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a secondary grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade ranges from 1 to 5, with 5 having the worst prognosis. The Gleason score ranges from 2 to 10, with 10 having the worst prognosis.

Time frame:
Years 0-3 (Final Biopsy)
Reported as:
Number · participants
Number of Participants With the Indicated Total Gleason Score
participantsMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Missing (No Cancer)3150
GS 500
GS 68371
GS 7, 3 (primary grade) + 4 (secondary grade)1513
GS 7, 4 (primary grade) + 3 (secondary grade)44
GS 832
GS 9-1000
SecondaryNumber of Biopsies With the Indicated Clinical Tumor Stage at Baseline

All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for clinical tumor staging were used. T1c = tumor identified by needle biopsy (e.g., because of elevated prostate-specific antigen \[PSA\]); T2 = tumor confined within the prostate; T2a = tumor involves one-half of one lobe, but not both lobes of the prostate.

Time frame:
Baseline
Reported as:
Number · biopsies
Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline
biopsiesMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
T1c125117
T2a3029
T2c01
Statistical analysis
  • Matching Placebo 0.5 mg Once Daily vs Dutasteride 0.5 mg Once Daily · Wilcoxon (Mann-Whitney) · p = 0.80
SecondaryNumber of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage

All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The National Comprehensive Network (NCCN), 2005 clinical practices guidelines in Oncology-prostate cancer were used for clinical tumor staging. T0: no evidence of primary tumor; T1: clinically inapparent tumor, neither palpable nor visible by imaging; T2: tumor confined within the prostate; T3: tumor extends through the prostate capsule; T4: tumor is fixed or invades adjacent structures other than seminal vesicles. A clinical stage of T0 in post-baseline biopsies has been interpreted as "No Worsening."

Time frame:
Months 0-18
Reported as:
Number · biopsies
Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage
biopsiesMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
No Worsening (same/lower stage)5353
Worsening (higher stage)135
Statistical analysis
  • Matching Placebo 0.5 mg Once Daily vs Dutasteride 0.5 mg Once Daily · Fisher Exact · p = 0.12
SecondaryProstate Volume (PV) LOCF

Prostate volume was determined at baseline, at Year 1.5, and at Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula: π/ 6 (anteroposterior width \* cephalocaudal width \* transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements.

Time frame:
Baseline and Years 1.5 and 3
Reported as:
Mean · cubic centimeters (cc)
Prostate Volume (PV) LOCF
cubic centimeters (cc)Matching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Baseline, n=133, 12644.2 ± 19.1743.2 ± 15.32
Year 1.5, n=117, 11743.1 ± 17.9743.3 ± 15.12
Year 3, n=118, 11843.0 ± 17.9443.1 ± 15.24
SecondaryChange From Baseline in Prostate Volume at Years 1.5 and 3

Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula: π/ 6 (anteroposterior width \* cephalocaudal width \* transverse width). Prostate volume calculated by pre-programmed equipment was unacceptable for the on-study prostate volume measurements.

Time frame:
Baseline and Years 1.5 and 3
Reported as:
Mean · cc
Change From Baseline in Prostate Volume at Years 1.5 and 3
ccMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Year 1.5, n=117, 1170.7 ± 11.70-9.5 ± 10.51
Year 3, n=118, 1183.3 ± 11.95-8.6 ± 10.89
SecondaryPercent Change From Baseline in Prostate Volume at Years 1.5 and 3

Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula: π/ 6 (anteroposterior width \* cephalocaudal width \* transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements.

Time frame:
Baseline and Years 1.5 and 3
Reported as:
Mean · percent change
Percent Change From Baseline in Prostate Volume at Years 1.5 and 3
percent changeMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Year 1.5, n=117, 1173.7 ± 25.24-19.8 ± 26.90
Year 3, n=118, 1187.7 ± 25.64-18.0 ± 27.98
SecondaryTotal Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)

The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.

Time frame:
Baseline and Month 3, 6, 12, 18, and 36
Reported as:
Mean · points on a scale
Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)
points on a scaleMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Baseline, n=151, 14611.0 ± 9.2811.3 ± 8.84
Month 3, n=150, 14411.4 ± 8.8011.4 ± 9.71
Month 6, n=152, 14410.9 ± 9.0110.4 ± 9.33
Month 12, n=152, 14410.7 ± 8.829.7 ± 8.93
Month 18, n=152, 14410.5 ± 8.969.5 ± 9.43
Month 18 Take-Home, n=152, 14411.4 ± 9.5310.6 ± 9.98
Month 36, n=152, 14411.3 ± 9.569.6 ± 9.75
Month 36 Take-Home, n=152, 14411.5 ± 9.689.4 ± 9.85
SecondaryChange From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF

The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.

Time frame:
Baseline and Months 3, 6, 12, 18, and 36
Reported as:
Mean · points on a scale
Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF
points on a scaleMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Month 3, n=146, 1430.4 ± 5.860.3 ± 7.04
Month 6, n=148, 143-0.0 ± 6.79-0.8 ± 7.15
Month 12, n=148, 143-0.1 ± 7.20-1.4 ± 7.58
Month 18, n=148, 143-0.3 ± 7.57-1.6 ± 8.25
Month 18 Take-Home, n=148, 1430.6 ± 8.39-0.6 ± 8.45
Month 36, n=148, 1430.5 ± 8.17-1.5 ± 8.30
Month 36 Take-Home, n=148, 1430.7 ± 8.66-1.8 ± 8.22
SecondaryTotal MAX-PC Anxiety Subscale Score Related to PSA Testing

The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; "I have been so anxious about my PSA test that I have thought about delaying it.", "I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test.", "I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate." A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9.

Time frame:
Baseline and Months 3, 6, 12, 18, and 36
Reported as:
Mean · points on a scale
Total MAX-PC Anxiety Subscale Score Related to PSA Testing
points on a scaleMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Baseline, n=154, 1477.1 ± 6.557.3 ± 6.35
Month 3, n=152, 1447.5 ± 6.167.5 ± 6.95
Month 6, n=152, 1447.0 ± 6.496.9 ± 6.60
Month 12, n=152, 1447.0 ± 6.276.6 ± 6.46
Month 18, n=152, 1446.7 ± 6.256.4 ± 6.78
Month 18 Take-Home, n=152, 1447.2 ± 6.757.1 ± 7.10
Month 36, n=152,1447.3 ± 6.586.5 ± 6.72
Month 36 Take-Home, n=152, 1447.4 ± 6.646.2 ± 6.95
SecondaryChange From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)

The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; "I have been so anxious about my PSA test that I have thought about delaying it.", "I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test.", "I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate." A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9.

Time frame:
Baseline and Months 3, 6, 12, 18, and 36
Reported as:
Mean · points on a scale
Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)
points on a scaleMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Month 30.7 ± 4.510.3 ± 5.12
Month 60.1 ± 5.08-0.3 ± 5.53
Month 120.1 ± 5.28-0.6 ± 5.76
Month 18-0.2 ± 5.40-0.8 ± 6.08
Month 18 Take-Home0.3 ± 6.10-0.1 ± 6.32
Month 360.4 ± 5.80-0.7 ± 5.97
Month 36 Take-Home0.5 ± 5.99-1.0 ± 5.91
SecondaryTotal MAX-PC Fear of Recurrence Subscale Score

The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; "Because cancer is unpredictable, I feel I cannot plan for the future.", "My fear of having my cancer getting worse gets in the way of my enjoying life.", "I am afraid of my cancer getting worse.", "I am more nervous since I was diagnosed with prostate cancer." A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12.

Time frame:
Baseline and Months 3, 6, 12, 18, and 36
Reported as:
Mean · points on a scale
Total MAX-PC Fear of Recurrence Subscale Score
points on a scaleMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Baseline, n=151, 1463.4 ± 2.513.4 ± 2.40
Month 3, n=150, 1443.2 ± 2.593.3 ± 2.66
Month 6, n=152, 1443.3 ± 2.572.9 ± 2.39
Month 12, n=152, 1443.2 ± 2.512.6 ± 2.37
Month 18, n=152, 1443.3 ± 2.522.7 ± 2.50
Month 18 Take-Home, n=152, 1443.4 ± 2.493.0 ± 2.70
Month 36, n=152, 1443.4 ± 2.672.7 ± 2.65
SecondaryChange From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)

The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; "Because cancer is unpredictable, I feel I cannot plan for the future.", "My fear of having my cancer getting worse gets in the way of my enjoying life.", "I am afraid of my cancer getting worse.", "I am more nervous since I was diagnosed with prostate cancer." A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12.

Time frame:
Baseline and Months 3, 6, 12, 18, and 36
Reported as:
Mean · points on a scale
Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)
points on a scaleMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Month 3, n=146, 143-0.2 ± 2.07-0.0 ± 2.19
Month 6, n= 148, 143-0.2 ± 2.15-0.5 ± 2.13
Month 12, n=148, 143-0.1 ± 2.38-0.7 ± 2.24
Month 18, n=148, 143-0.1 ± 2.34-0.7 ± 2.31
Month 18 Take-Home, n=148, 1430.0 ± 2.35-0.3 ± 2.56
Month 36, n=148, 1430.0 ± 2.32-0.6 ± 2.64
Month 36 Take-Home, n=148, 1430.0 ± 2.56-0.7 ± 2.55
SecondaryTotal Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score

The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better quality of life.

Time frame:
Baseline and Months 18 and 36
Reported as:
Mean · points on a scale
Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score
points on a scaleMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Baseline, n=154, 145129.9 ± 17.45131.3 ± 15.07
Month 18, n=145, 140126.9 ± 16.03130.2 ± 16.29
Month 36, n=149, 140126.6 ± 17.00129.0 ± 16.85
SecondaryChange From Baseline in Total FACT-P Score (LOCF)

The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.

Time frame:
Baseline and Months 18 and 36
Reported as:
Mean · points on a scale
Change From Baseline in Total FACT-P Score (LOCF)
points on a scaleMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Month 18, n=144, 140-4.2 ± 11.89-1.2 ± 14.61
Month 36, n=148, 140-3.7 ± 15.55-2.3 ± 15.74
SecondaryPercent Change From Baseline in Total FACT-P Score (LOCF)

The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.

Time frame:
Baseline and Months 18 and 36
Reported as:
Mean · points on a scale
Percent Change From Baseline in Total FACT-P Score (LOCF)
points on a scaleMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Month 18, n=144, 140-2.8 ± 10.49-0.2 ± 13.44
Month 36, n=148, 140-1.8 ± 16.39-1.0 ± 14.16
SecondaryChange From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF)

The FACT-P Physical Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; "I have a lack of energy.", "I have nausea.", "Because of my physical condition, I have trouble meeting the needs of my family.", "I have pain.", "I am bothered by side effects of treatment.", "I feel ill.", "I am forced to spend time in bed." The score for each question ranges from 0 to 4; a lower score indicates better physical well-being. The total FACT-P score thus ranges from 0 to156; a higher score indicates a better quality of life.

Time frame:
Baseline and Months 18 and 36
Reported as:
Mean · points on a scale
Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF)
points on a scaleMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Month 18, n=148, 140-0.4 ± 2.48-0.2 ± 2.28
Month 36, n=149, 140-0.3 ± 2.65-0.3 ± 2.58
SecondaryChange From Baseline in FACT-P Social Well-Being Subscale Score (LOCF)

The FACT-P Social Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; "I feel close to my friends.", "I get emotional support from my family.", "I get support from my friends.", "My family has accepted my illness.", "I am satisfied with family communication about my illness.", "I feel close to my partner (or the person who is my main support).", "I am satisfied with my sex life." The score for each question ranges from 0 to 4; a higher score indicates better social well-being. The total FACT-P score thus ranges from 0 to 156.

Time frame:
Baseline and Months 18 and 36
Reported as:
Mean · points on a scale
Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF)
points on a scaleMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Month 18, n=148, 140-1.4 ± 5.32-0.6 ± 5.95
Month 36, n=149, 140-1.1 ± 6.04-1.2 ± 6.59

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Matching Placebo 0.5 mg Once Daily—23/155 (14.8%)67/155 (43.2%)
Dutasteride 0.5 mg Once Daily—22/147 (15%)56/147 (38.1%)
Most frequent serious events
Showing 10 of 49
Most frequent serious events
EventMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
Rectal haemorrhageGastrointestinal disorders0/1552/147
Coronary artery diseaseCardiac disorders2/1551/147
ArrhythmiaCardiac disorders0/1551/147
Coronary artery occlusionCardiac disorders0/1551/147
Myocardial infarctionCardiac disorders0/1551/147
Myocardial ischaemiaCardiac disorders0/1551/147
Transient ischaemic attackNervous system disorders1/1551/147
Cerebral infarctionNervous system disorders0/1551/147
Cerebrovascular accidentNervous system disorders0/1551/147
SyncopeNervous system disorders0/1551/147
Most frequent other events
Showing 10 of 11
Most frequent other events
EventMatching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once Daily
NasopharyngitisInfections and infestations15/1558/147
Erectile dysfunctionReproductive system and breast disorders14/15513/147
Back painMusculoskeletal and connective tissue disorders9/15513/147
Urinary tract infectionInfections and infestations11/1557/147
Libido decreasedReproductive system and breast disorders6/15510/147
HypertensionVascular disorders10/1555/147
FatigueGeneral disorders9/1557/147
Musculoskeletal painMusculoskeletal and connective tissue disorders9/1554/147
ArthralgiaMusculoskeletal and connective tissue disorders7/1558/147
SinusitisInfections and infestations4/1558/147

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Matching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once DailyTotal
Mean65.0 ± 7.5665.1 ± 7.1365.0 ± 7.34
Gender
Gender(Participants)Matching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once DailyTotal
Female000
Male155147302
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Matching Placebo 0.5 mg Once DailyDutasteride 0.5 mg Once DailyTotal
White141132273
African American12820
Asian145
American Indian or Alaskan Native011
Native Hawaiian or Other Pacific Islander112
White and American Indian/Alaskan Native011
08

Study locations

82 sites
  • GSK Investigational Site
    Little Rock, Arkansas 72211, United States
  • GSK Investigational Site
    Beverly Hills, California 90210, United States
  • GSK Investigational Site
    Laguna Hills, California 92653, United States
  • GSK Investigational Site
    Mission Hills, California 91345, United States
  • GSK Investigational Site
    Modesto, California 95350, United States
  • GSK Investigational Site
    San Bernardino, California 92404, United States
  • GSK Investigational Site
    Torrance, California 90506, United States
  • GSK Investigational Site
    Englewood, Colorado 80113, United States
  • GSK Investigational Site
    Wheat Ridge, Colorado 80033, United States
  • GSK Investigational Site
    New Britain, Connecticut 06052, United States
  • GSK Investigational Site
    Trumbull, Connecticut 06611, United States
  • GSK Investigational Site
    Washington, District of Columbia 20307, United States
  • GSK Investigational Site
    Jacksonville, Florida 32224, United States
  • GSK Investigational Site
    Largo, Florida 33773, United States
  • GSK Investigational Site
    Orlando, Florida 32803, United States
  • GSK Investigational Site
    Roswell, Georgia 30076, United States
  • GSK Investigational Site
    Coeur D'Alene, Idaho 83814, United States
  • GSK Investigational Site
    Chicago, Illinois 60612, United States
  • GSK Investigational Site
    Melrose Park, Illinois 60160, United States
  • GSK Investigational Site
    Fort Wayne, Indiana 46825, United States
  • GSK Investigational Site
    Newburgh, Indiana 47630, United States
  • GSK Investigational Site
    Overland Park, Kansas 66211, United States
  • GSK Investigational Site
    Shreveport, Louisiana 71106, United States
  • GSK Investigational Site
    Annapolis, Maryland 21401, United States
  • GSK Investigational Site
    Greenbelt, Maryland 20770, United States
  • GSK Investigational Site
    Watertown, Massachusetts 02472, United States
  • GSK Investigational Site
    Minneapolis, Minnesota, United States
  • GSK Investigational Site
    St. Cloud, Minnesota 56303, United States
  • GSK Investigational Site
    Jackson, Mississippi 39202, United States
  • GSK Investigational Site
    St. Louis, Missouri 63136, United States
  • GSK Investigational Site
    Las Vegas, Nevada 89148, United States
  • GSK Investigational Site
    Marlton, New Jersey 08053, United States
  • GSK Investigational Site
    Albuquerque, New Mexico 87109, United States
  • GSK Investigational Site
    Albany, New York 12208, United States
  • GSK Investigational Site
    Elmont, New York 11003, United States
  • GSK Investigational Site
    Garden City, New York 11530, United States
  • GSK Investigational Site
    New York, New York 10016, United States
  • GSK Investigational Site
    Orchard Park, New York 14127, United States
  • GSK Investigational Site
    Syracuse, New York 13210, United States
  • GSK Investigational Site
    Greensboro, North Carolina 27403, United States
  • GSK Investigational Site
    Salisbury, North Carolina 28144, United States
  • GSK Investigational Site
    Winston-Salem, North Carolina 27103, United States
  • GSK Investigational Site
    Columbus, Ohio 43214, United States
  • GSK Investigational Site
    Springfield, Oregon 97477, United States
  • GSK Investigational Site
    Bala Cynwyd, Pennsylvania 19004, United States
  • GSK Investigational Site
    Lancaster, Pennsylvania 17604, United States
  • GSK Investigational Site
    Philadelphia, Pennsylvania 19107, United States
  • GSK Investigational Site
    Memphis, Tennessee 38119, United States
  • GSK Investigational Site
    Nashville, Tennessee 37232, United States
  • GSK Investigational Site
    San Antonio, Texas 78229, United States
  • GSK Investigational Site
    Temple, Texas 76508, United States
  • GSK Investigational Site
    Salt Lake City, Utah 84107, United States
  • GSK Investigational Site
    Richmond, Virginia 23235, United States
  • GSK Investigational Site
    Virginia Beach, Virginia 23455, United States
  • GSK Investigational Site
    Williamsburg, Virginia 23185, United States
  • GSK Investigational Site
    Seattle, Washington 98101, United States
  • GSK Investigational Site
    Seattle, Washington 98166, United States
  • GSK Investigational Site
    Spokane, Washington 99202, United States
  • GSK Investigational Site
    Surrey, British Columbia V3V 1N1, Canada
  • GSK Investigational Site
    Victoria, British Columbia V8T 5G1, Canada
  • GSK Investigational Site
    Victoria, British Columbia V8V 3N1, Canada
  • GSK Investigational Site
    Fredericton, New Brunswick E3B 5B8, Canada
  • GSK Investigational Site
    Barrie, Ontario L4M 7G1, Canada
  • GSK Investigational Site
    Brampton, Ontario L6T 3J1, Canada
  • GSK Investigational Site
    Brantford, Ontario N3R 4N3, Canada
  • GSK Investigational Site
    Burlington, Ontario L7N 3V2, Canada
  • GSK Investigational Site
    Burlington, Ontario L7S 1V2, Canada
  • GSK Investigational Site
    Guelph, Ontario N1H 5J1, Canada
  • GSK Investigational Site
    Kitchener, Ontario N2N 2B9, Canada
  • GSK Investigational Site
    North Bay, Ontario P1B 4Z2, Canada
  • GSK Investigational Site
    Oakville, Ontario L6H 3P1, Canada
  • GSK Investigational Site
    Scarborough, Ontario M1P 2T7, Canada
  • GSK Investigational Site
    Toronto, Ontario M4C 5T2, Canada
  • GSK Investigational Site
    Toronto, Ontario M5G 2M9, Canada
  • GSK Investigational Site
    Toronto, Ontario M6A 3B5, Canada
  • GSK Investigational Site
    Chicoutimi, Quebec G7H 4A3, Canada
  • GSK Investigational Site
    Greenfield Park, Quebec J4V 2H3, Canada
  • GSK Investigational Site
    Laval, Quebec H7G 2E6, Canada
  • GSK Investigational Site
    Montreal, Quebec H3G 1A4, Canada
  • GSK Investigational Site
    Pointe-Claire, Quebec H9R 4S3, Canada
  • GSK Investigational Site
    Quebec City, Quebec G1R 2J6, Canada
  • GSK Investigational Site
    Trois Rivieres, Quebec G9A 3V7, Canada
09

References and documents

Publications

  • Fleshner NE, Lucia MS, Egerdie B, Aaron L, Eure G, Nandy I, Black L, Rittmaster RS. Dutasteride in localised prostate cancer management: the REDEEM randomised, double-blind, placebo-controlled trial. Lancet. 2012 Mar 24;379(9821):1103-11. doi: 10.1016/S0140-6736(11)61619-X. Epub 2012 Jan 24. PubMed 22277570 ↗
  • Moreira DM, Fleshner NE, Freedland SJ. Baseline Perineural Invasion is Associated with Shorter Time to Progression in Men with Prostate Cancer Undergoing Active Surveillance: Results from the REDEEM Study. J Urol. 2015 Nov;194(5):1258-63. doi: 10.1016/j.juro.2015.04.113. Epub 2015 May 16. PubMed 25988518 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00363311
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Aug 15, 2006
Start date
Jul 2006
Primary completion
Mar 2010
Completion
Jul 2010
Results posted
Jun 14, 2011
Last update
Jan 18, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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