A Phase 2 interventional study of Avodart and placebo in Neoplasms, Prostate and Prostate Cancer After a Radical Treatment, sponsored by GlaxoSmithKline. Completed at 66 sites in 9 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2012-03-21.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
ARI109924 will be a 2-year, multicentre, randomised, double-blind, placebo-controlled trial assessing the efficacy and safety of dutasteride in extending time to prostate specific antigen (PSA) doubling in men who have been treated for clinically localised prostate cancer (PCa) with a radical therapy (radical prostatectomy, primary radiotherapy or salvage radiotherapy) with curative intent but who experience a biochemical failure (PSA rise) afterwards without signs or symptoms of metastases.
A Randomised, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride (AVODART™) 0.5 mg in Extending the Time to PSA Doubling in Men with Prostate Cancer and Biochemical Failure (PSA increase) after Radical Therapy with Curative Intent (ARTS - AVODART after Radical Therapy for prostate cancer Study)
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 294 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →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.
Patients eligible for enrolment in the study must meet all of the following criteria:
Miscellaneous:
Exclusion Criteria:
Disease characteristics:
Concomitant medications:
Patients will receive a 3-month supply of study drug or placebo. Patients will be instructed to take one capsule by mouth once daily. Study medication will be supplied at 3-month intervals during scheduled clinic visits for a total of 24 months.
Drug: Avodart
Patients will receive a 3-month supply of study drug or placebo. Patients will be instructed to take one capsule by mouth once daily. Study medication will be supplied at 3-month intervals during scheduled clinic visits for a total of 24 months.
Other: placebo
0.5 mg administered orally once daily
Also known as: Avodart/placebo
Patients will be randomized at Visit 2 in 1:1 ratio to receive either 0.5 mg dutasteride or placebo
Time to Prostate-specific Antigen (PSA) Doubling From Baseline (in Days)
Time to PSA doubling is defined as the number of days between the baseline date and the study day of the first post-baseline PSA evaluation date (within treatment period, typically up to 24-month evaluations) on which the PSA value was at least twice as much as the baseline PSA value, and the immediate subsequent value, if available, was at least 85% of two times the baseline value. Participants who never achieved PSA doubling were censored at the last post-baseline, non-missing PSA evaluation.
Time frame: up to 28 months
Number of Participants With PSA Doubling From Baseline
PSA doubling is defined as the first post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was at least twice as much as the baseline PSA value and was confirmed as such (at least 85% of two times the baseline PSA value) in the immediate subsequent PSA value if one is available.
Time frame: up to 28 months
Time to PSA Doubling From Baseline (in Days) Within Year 1
Time to PSA doubling is defined as the number of days between the baseline date and the study day of the first post-baseline PSA evaluation date within Year 1 (Y1; within treatment period, typically up to 12-month evaluations) on which the PSA value was at least twice as much as the baseline PSA value, and the immediate subsequent value, if available, was at least 85% of two times the baseline value.
Time frame: up to 16 months
Number of Participants With PSA Doubling From Baseline During Year 1
PSA doubling is defined as the first post-baseline PSA value (within treatment period, typically up to 12-month evaluations) that was at least twice as much as the baseline PSA value and was confirmed as such (at least 85% of two times the baseline PSA value) in the immediate subsequent PSA value if one is available.
Time frame: up to 16 months
Time to Disease Progression From Baseline (in Days)
Time to disease progression is defined as the number of days between baseline and the first occurrence of any of the following: PSA doubling time (PSADT)\<=91 days, PSA value is at least 50% more than baseline value (\>20 nanogram/milliliter \[ng/ml\] for primary radiotherapy group or \>10 ng/ml for radical prostatectomy group), rescue treatment, cancer-positive biopsy, cancer-positive bone scan. (Confirmation of PSA criteria is required in an immediate subsequent PSA, if available, and PSA values for consideration are restricted to treatment period, typically up to 24-month evaluations.)
Time frame: up to 28 months
Number of Participants With Disease Progression
Disease progression is defined as the first occurrence of any of the following: PSADT\<=91 days, PSA value is at least 50% more than baseline value (\>20 ng/ml for primary radiotherapy group or \>10 ng/ml for radical prostatectomy group), rescue treatment, cancer-positive biopsy, cancer-positive bone scan. If one of the PSA criteria is qualifying (within treatment period, typically up to 24-month evaluations), an immediate subsequent PSA, if available, must confirm either criterion (or at least 85% of the qualifying value).
Time frame: up to 28 months
Number of Participants Classified as Treatment Responders at Months 3, 6, 9, 12, 15, 18, 21, and 24
Treatment responders at Month X were defined as participants (par.) with either a PSA decrease or an increase \<=15% from baseline to Month X confirmed in all PSA measurements between baseline (BL) and Month X.
Time frame: Months 3, 6, 9, 12, 15, 18, 21, and 24
Time to PSA Rise From Baseline (in Days)
A participant was designated as having a PSA rise if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was \>1.15 times the baseline PSA value, and all subsequent PSA values were \>1.15 times the baseline PSA value. The study day for the first PSA evaluation that qualified for analysis of PSA rise was used for time to PSA rise. If none of the post-baseline PSA values qualified for analysis of PSA rise during the study, time to PSA rise was censored at the last post-baseline PSA evaluation.
Time frame: up to 28 months
Number of Participants With a PSA Rise From Baseline
A participant was designated as having a PSA rise if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evluations) that was \>1.15 times the baseline PSA value, and all subsequent PSA values were \>1.15 times the baseline PSA value.
Time frame: up to 28 months
Time to PSA Progression (in Days)
A participant was designated as having PSA progression if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was \>10 ng/ml if radical prostatectomy or \>20 ng/ml if primary radiotherapy and PSA \>=1.5 times the baseline PSA value, or 0\<PSADT\<=91 days, and all subsequent PSA values satisfied these criteria. The study day for the first PSA qualifying for progression was used for time to PSA progression. If none of the PSA values qualified for PSA progression, time to PSA progression was censored at the last post-baseline PSA evaluation.
Time frame: up to 28 months
Number of Participants With PSA Progression
A participant was designated as having a PSA progression if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was (\>10 ng/ml if radical prostatectomy or \>20 ng/ml if primary radiotherapy) and PSA \>=1.5 times the baseline PSA value), or 0\<PSADT\<=91 days, and all subsequent PSA values satisfied either of these criteria.
Time frame: up to 28 months
Change in Total PSA From Baseline at Months 12 and 24
Change in PSA from baseline at Month X = Month X PSA - Baseline PSA. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).
Time frame: Baseline; Months 12 and 24
Percent Change in Total PSA From Baseline at Months 12 and 24
Percent change in PSA from baseline at Month X = 100\*(Month X PSA - Baseline PSA)/Baseline PSA. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).
Time frame: Baseline; Months 12 and 24
Change in PSA From Nadir PSA at Months 12 and 24
Change from nadir PSA at Month X = Month X PSA - nadir PSA. Nadir PSA was reported by the site as the lowest historical PSA value after the radical therapy. A nadir value below the detection level was captured as 0.0. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).
Time frame: Baseline; Months 12 and 24
Percent Change in PSA From Nadir PSA at Months 12 and 24
Percent change from nadir PSA at Month X = 100\*(Month X PSA - nadir PSA)/Nadir PSA. Nadir PSA was reported by the site as the lowest historical PSA value after the radical therapy. A nadir value below the detection level was captured as 0.0. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).
Time frame: Baseline; Months 12 and 24
Number of Participants With the Indicated Change in PSA Doubling Time (PSADT) From Baseline at Month 12, Month 24, and End-of-treatment (up to 28 Months)
Participants with improvement included those whose PSADT at a specified visit was positive but more than the baseline PSADT, whose PSA at the visit was the same as the baseline PSA, or whose PSA at the visit was less than the baseline PSA. Participants with worsening included those whose PSADT at the visit was positive but less than the baseline PSADT.
Time frame: Baseline; Month 12, Month 24, End-of-Treatment (up to 28 months)
Changes From Baseline in Disease-related Anxiety Measured by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
MAX-PC is an 18-item, self-reported measure that evaluates prostate cancer-related anxiety. The score ranges from 0 to 54, and an increase in the score indicates a worsened anxiety level. Change from Baseline at Month X = Month X MAX-PC score - Baseline MAX-PC score. A missing post-baseline value is replaced by the last available post-baseline value (Last Observation Carried Forward(LOCF)). A general linear model controls for previous therapy, site cluster, and baseline MAX-PC score.
Time frame: Baseline; Months 3, 6, 12, 18, and 24
Number of Participants With a Shift From Normal at Baseline to at Least One Abnormal Laboratory Value for Any Parameter Any Time During the Study
A participant has a normal value for a laboratory parameter if the value is within the low and high range of normal provided by the laboratory. Each laboratory parameter is evaluated for shift from normal at baseline to abnormal any time post-baseline. A participant with any laboratory parameter showing this shift is counted. A participant is counted only once even if he had such a shift in more than one laboratory parameter or more than once among all post-baseline evaluations.
Time frame: Baseline; up to 28 months
Number of Participants With a Threshold Laboratory Value for Any Parameter at Baseline (BL) and Any Time Post-baseline
Threshold laboratory values are defined in terms of a multiplicative factor of the testing laboratory's normal range, pre-specified in the analysis plan. A laboratory value that is above the upper limit factor multiplied by the upper limit of the normal range is considered a high threshold value. A laboratory value that is below the lower limit factor multiplied by the lower limit of the normal range is considered a low threshold value.
Time frame: Baseline; up to 28 months
Number of Participants With Palpable Breast Tissue (PBT) at Baseline (BL) and Any Time Post-baseline
Participants underwent clinical examination of the breasts, to evaluate for palpable breast tissue. Clinical significance of the results was determined by subjective judgment of the clinical personnel performing the examination.
Time frame: Baseline; up to 28 months
Number of Participants With Nipple Tenderness (NT) at Baseline (BL) and Any Time Post-baseline
Participants underwent clinical examination of the breasts, to evaluate for nipple tenderness. Clinical significance of the results was determined by subjective judgment of the clinical personnel performing the examination.
Time frame: Baseline; up to 28 months
Number of Participants With a Digital Rectal Examination (DRE) Evaluation Changing From Normal/Diffusely Enlarged at Baseline to Focal Abnormality at Any Time Post-baseline
Participants underwent a digital rectal examination to evaluate for focal abnormality of the prostate.
Time frame: Baseline; up to 28 months
Number of Participants With Threshold Vital Signs at Baseline and Any Time Post-baseline
Threshold vital signs are defined as follows: \< 80 mmHg or \> 165 mmHg for systolic blood pressure; \< 40 mmHg or \> 105 mm Hg for diastolic blood pressure, \< 40 beats per minute (bpm) or \> 100 bpm for heart rate.
Time frame: Baseline; up to 28 months
| Milestone | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| Started | 147 | 147 |
| Completed | 76 | 111 |
| Not completed | 71 | 36 |
| Withdrew: Physician decision | 18 | 4 |
| Withdrew: Withdrawal by subject | 11 | 4 |
| Withdrew: Adverse event | 5 | 5 |
| Withdrew: Lack of efficacy | 2 | 2 |
| Withdrew: Protocol violation | 2 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Met protocol-defined stopping criteria | 32 | 16 |
| Withdrew: Randomized in error | 1 | 2 |
| Withdrew: Hospitalized; unable to continue | 0 | 1 |
Time to PSA doubling is defined as the number of days between the baseline date and the study day of the first post-baseline PSA evaluation date (within treatment period, typically up to 24-month evaluations) on which the PSA value was at least twice as much as the baseline PSA value, and the immediate subsequent value, if available, was at least 85% of two times the baseline value. Participants who never achieved PSA doubling were censored at the last post-baseline, non-missing PSA evaluation.
| days | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| Participants (par.) with PSA doubling; n=82, 41 | 365.5 (90 to 736) | 458.0 (91 to 736) |
| Par. without PSA doubling (censored); n=62, 105 | NA (NA to NA) | NA (NA to NA) |
Time to disease progression is defined as the number of days between baseline and the first occurrence of any of the following: PSA doubling time (PSADT)\<=91 days, PSA value is at least 50% more than baseline value (\>20 nanogram/milliliter \[ng/ml\] for primary radiotherapy group or \>10 ng/ml for radical prostatectomy group), rescue treatment, cancer-positive biopsy, cancer-positive bone scan. (Confirmation of PSA criteria is required in an immediate subsequent PSA, if available, and PSA values for consideration are restricted to treatment period, typically up to 24-month evaluations.)
| days | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| Time to Disease Progression From Baseline (in Days) | 365.0 (39 to 824) | 285.0 (22 to 808) |
Disease progression is defined as the first occurrence of any of the following: PSADT\<=91 days, PSA value is at least 50% more than baseline value (\>20 ng/ml for primary radiotherapy group or \>10 ng/ml for radical prostatectomy group), rescue treatment, cancer-positive biopsy, cancer-positive bone scan. If one of the PSA criteria is qualifying (within treatment period, typically up to 24-month evaluations), an immediate subsequent PSA, if available, must confirm either criterion (or at least 85% of the qualifying value).
| participants | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| With disease progression | 49 | 25 |
| Without disease progression | 95 | 121 |
Treatment responders at Month X were defined as participants (par.) with either a PSA decrease or an increase \<=15% from baseline to Month X confirmed in all PSA measurements between baseline (BL) and Month X.
| participants | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| Month 3, n=141, 141 | 64 | 117 |
| Month 6, n=131, 135 | 36 | 105 |
| Month 9, n=121, 129 | 22 | 95 |
| Month 12, n=110, 124 | 13 | 87 |
| Month 15, n=100, 121 | 10 | 82 |
| Month 18, n=95, 120 | 8 | 76 |
| Month 21, n=83, 112 | 7 | 70 |
| Month 24, n=76, 110 | 6 | 62 |
A participant was designated as having a PSA rise if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was \>1.15 times the baseline PSA value, and all subsequent PSA values were \>1.15 times the baseline PSA value. The study day for the first PSA evaluation that qualified for analysis of PSA rise was used for time to PSA rise. If none of the post-baseline PSA values qualified for analysis of PSA rise during the study, time to PSA rise was censored at the last post-baseline PSA evaluation.
| days | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| Time to PSA Rise From Baseline (in Days) | 100.0 (39 to 729) | 279.0 (22 to 805) |
A participant was designated as having a PSA rise if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evluations) that was \>1.15 times the baseline PSA value, and all subsequent PSA values were \>1.15 times the baseline PSA value.
| participants | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| With PSA rise | 127 | 72 |
| Without PSA rise | 17 | 74 |
A participant was designated as having PSA progression if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was \>10 ng/ml if radical prostatectomy or \>20 ng/ml if primary radiotherapy and PSA \>=1.5 times the baseline PSA value, or 0\<PSADT\<=91 days, and all subsequent PSA values satisfied these criteria. The study day for the first PSA qualifying for progression was used for time to PSA progression. If none of the PSA values qualified for PSA progression, time to PSA progression was censored at the last post-baseline PSA evaluation.
| days | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| Time to PSA Progression (in Days) | 368.0 (90 to 736) | 368.0 (22 to 735) |
A participant was designated as having a PSA progression if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was (\>10 ng/ml if radical prostatectomy or \>20 ng/ml if primary radiotherapy) and PSA \>=1.5 times the baseline PSA value), or 0\<PSADT\<=91 days, and all subsequent PSA values satisfied either of these criteria.
| participants | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| With PSA progression | 25 | 19 |
| Without PSA progression | 119 | 127 |
Change in PSA from baseline at Month X = Month X PSA - Baseline PSA. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).
| nanograms/milliliter (ng/ml) | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| Month 12 | 2.3 ± 4.86 | 0.9 ± 7.25 |
| Month 24 | 3.9 ± 6.09 | 2.3 ± 7.60 |
Percent change in PSA from baseline at Month X = 100\*(Month X PSA - Baseline PSA)/Baseline PSA. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).
| percent change | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| Month 12 | 93.1 ± 115.02 | 11.8 ± 103.41 |
| Month 24 | 197.3 ± 282.41 | 86.2 ± 193.95 |
PSA doubling is defined as the first post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was at least twice as much as the baseline PSA value and was confirmed as such (at least 85% of two times the baseline PSA value) in the immediate subsequent PSA value if one is available.
| participants | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| With PSA doubling | 82 | 41 |
| Without PSA doubling | 62 | 105 |
Time to PSA doubling is defined as the number of days between the baseline date and the study day of the first post-baseline PSA evaluation date within Year 1 (Y1; within treatment period, typically up to 12-month evaluations) on which the PSA value was at least twice as much as the baseline PSA value, and the immediate subsequent value, if available, was at least 85% of two times the baseline value.
| days | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| Participants with PSA doubling in Y1; n=50, 15 | 273.5 (90 to 486) | 183.0 (91 to 383) |
| Participants without PSA doubling in Y1: n=94, 131 | NA (NA to NA) | NA (NA to NA) |
PSA doubling is defined as the first post-baseline PSA value (within treatment period, typically up to 12-month evaluations) that was at least twice as much as the baseline PSA value and was confirmed as such (at least 85% of two times the baseline PSA value) in the immediate subsequent PSA value if one is available.
| participants | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| With PSA doubling | 50 | 15 |
| Without PSA doubling | 94 | 131 |
Change from nadir PSA at Month X = Month X PSA - nadir PSA. Nadir PSA was reported by the site as the lowest historical PSA value after the radical therapy. A nadir value below the detection level was captured as 0.0. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).
| ng/ml | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| Month 12 | 4.7 ± 6.31 | 3.5 ± 9.04 |
| Month 24 | 6.3 ± 7.34 | 4.9 ± 9.65 |
Percent change from nadir PSA at Month X = 100\*(Month X PSA - nadir PSA)/Nadir PSA. Nadir PSA was reported by the site as the lowest historical PSA value after the radical therapy. A nadir value below the detection level was captured as 0.0. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).
| percent change | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| Month 12 | 2810.3 ± 4062.48 | 2120.7 ± 5284.72 |
| Month 24 | 4036.1 ± 5860.98 | 2927.2 ± 6146.34 |
Participants with improvement included those whose PSADT at a specified visit was positive but more than the baseline PSADT, whose PSA at the visit was the same as the baseline PSA, or whose PSA at the visit was less than the baseline PSA. Participants with worsening included those whose PSADT at the visit was positive but less than the baseline PSADT.
| participants | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| Month 12, Worsening; n=110, 123 | 20 | 7 |
| Month 12, No change; n=110, 123 | 0 | 0 |
| Month 12, Improvement; n=110, 123 | 90 | 116 |
| Month 24, Worsening; n=76, 110 | 7 | 3 |
| Month 24, No change; n=76, 110 | 0 | 0 |
| Month 24, Improvement; n=76, 110 | 69 | 107 |
| End-of treatment, Worsening; n=144, 144 | 37 | 19 |
| End-of treatment, No change; n=144, 144 | 0 | 0 |
| End-of treatment, Improvement; n=144, 144 | 107 | 125 |
MAX-PC is an 18-item, self-reported measure that evaluates prostate cancer-related anxiety. The score ranges from 0 to 54, and an increase in the score indicates a worsened anxiety level. Change from Baseline at Month X = Month X MAX-PC score - Baseline MAX-PC score. A missing post-baseline value is replaced by the last available post-baseline value (Last Observation Carried Forward(LOCF)). A general linear model controls for previous therapy, site cluster, and baseline MAX-PC score.
| scores on a scale | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| Month 3, n=144, 141 | -1.6 ± 0.63 | -1.4 ± 0.63 |
| Month 6, n=144, 143 | -2.2 ± 0.63 | -3.1 ± 0.62 |
| Month 12, n=144, 143 | -0.8 ± 0.72 | -2.9 ± 0.72 |
| Month 18, n=144, 143 | -1.1 ± 0.79 | -2.2 ± 0.78 |
| Month 24, n=144, 143 | -0.4 ± 0.78 | -1.4 ± 0.77 |
A participant has a normal value for a laboratory parameter if the value is within the low and high range of normal provided by the laboratory. Each laboratory parameter is evaluated for shift from normal at baseline to abnormal any time post-baseline. A participant with any laboratory parameter showing this shift is counted. A participant is counted only once even if he had such a shift in more than one laboratory parameter or more than once among all post-baseline evaluations.
| participants | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| Number of Participants With a Shift From Normal at Baseline to at Least One Abnormal Laboratory Value for Any Parameter Any Time During the Study | 74 | 64 |
Threshold laboratory values are defined in terms of a multiplicative factor of the testing laboratory's normal range, pre-specified in the analysis plan. A laboratory value that is above the upper limit factor multiplied by the upper limit of the normal range is considered a high threshold value. A laboratory value that is below the lower limit factor multiplied by the lower limit of the normal range is considered a low threshold value.
| participants | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| Threshold at BL | 5 | 9 |
| Non-threshold at BL; threshold at any time post-BL | 11 | 5 |
Participants underwent clinical examination of the breasts, to evaluate for palpable breast tissue. Clinical significance of the results was determined by subjective judgment of the clinical personnel performing the examination.
| participants | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| BL; PBT, n=147, 147 | 6 | 4 |
| BL; Clinically significant (CS) PBT, n=6, 4 | 0 | 0 |
| No BL PBT, but PBT at any time post-BL, n=147,147 | 10 | 21 |
| CS change in PBT; BL to any time post-BL, n=10, 21 | 0 | 4 |
Participants underwent clinical examination of the breasts, to evaluate for nipple tenderness. Clinical significance of the results was determined by subjective judgment of the clinical personnel performing the examination.
| participants | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| BL; NT, n=147, 147 | 0 | 3 |
| BL; Clinically significant (CS) NT, n=0, 3 | 0 | 0 |
| No NT at BL, but NT at any time post-BL, n=147,147 | 8 | 11 |
| CS change in NT; BL to any time post-BL, n=8, 11 | 0 | 1 |
Participants underwent a digital rectal examination to evaluate for focal abnormality of the prostate.
| participants | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| Number of Participants With a Digital Rectal Examination (DRE) Evaluation Changing From Normal/Diffusely Enlarged at Baseline to Focal Abnormality at Any Time Post-baseline | 10 | 8 |
Threshold vital signs are defined as follows: \< 80 mmHg or \> 165 mmHg for systolic blood pressure; \< 40 mmHg or \> 105 mm Hg for diastolic blood pressure, \< 40 beats per minute (bpm) or \> 100 bpm for heart rate.
| participants | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| Baseline | 18 | 15 |
| Any time post-baseline | 37 | 36 |
Collected over Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to the End of Study (up to 28 months after treatment start).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 16/147 (10.9%) | 31/147 (21.1%) |
| Dutasteride 0.5 mg | — | 16/147 (10.9%) | 32/147 (21.8%) |
| Event | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| Metastases to liverNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/147 | 1/147 |
| Bladder cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/147 | 0/147 |
| Bladder cancer recurrentNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/147 | 0/147 |
| Bladder neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/147 | 1/147 |
| Hepatic neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/147 | 1/147 |
| Metastases to boneNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/147 | 0/147 |
| Neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/147 | 1/147 |
| Prostate cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/147 | 0/147 |
| Lung cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/147 | 0/147 |
| Non-small cell lung cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/147 | 0/147 |
| Event | Placebo | Dutasteride 0.5 mg |
|---|---|---|
| NasopharyngitisInfections and infestations | 10/147 | 14/147 |
| Back painMusculoskeletal and connective tissue disorders | 11/147 | 4/147 |
| GynaecomastiaReproductive system and breast disorders | 4/147 | 10/147 |
| HypertensionVascular disorders | 10/147 | 4/147 |
| Urinary incontinenceRenal and urinary disorders | 4/147 | 8/147 |
| Age Continuous(Years) | Placebo | Dutasteride 0.5 mg | Total |
|---|---|---|---|
| Mean | 68.6 ± 6.53 | 69.7 ± 5.76 | 69.1 ± 6.17 |
| Sex: Female, Male(Participants) | Placebo | Dutasteride 0.5 mg | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 147 | 147 | 294 |
| Race/Ethnicity, Customized(participants) | Placebo | Dutasteride 0.5 mg | Total |
|---|---|---|---|
| White - Caucasian/European Heritage | 145 | 147 | 292 |
| White - Arabic/North African Heritage | 1 | 0 | 1 |
| Asian - Central/Soth Asian Heritage | 1 | 0 | 1 |
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