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CompletedNCT02737332STAARUpdated Nov 22, 2021Results posted

A Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer

A Phase 2 interventional study of Zytiga® (Abiraterone Acetate) and SoluMatrix™ (Abiraterone Acetate) in Prostate Cancer, sponsored by Sun Pharmaceutical Industries Limited. Completed at 17 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-22.

Sponsored by Sun Pharmaceutical Industries Limited · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

The purpose of this study is to evaluate the serum testosterone levels in patients with Metastatic Castration-Resistant Prostate Cancer on SoluMatrix™ Abiraterone Acetate as Compared to Abiraterone Acetate

Read the detailed description

This was a 12-week, open-label study of abiraterone acetate in at least 50 patients with metastatic castration-resistant prostate cancer.

02

Conditions studied

  • Prostate Cancer

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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 53 is close to the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Sun Pharmaceutical Industries Limited is the lead sponsor of 58 studies on the registry; 5 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 22 (92%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  1. Written informed consent obtained prior to any study-related procedure being performed
  2. Male subjects at least 18 years of age or older at time of consent
  3. Pathologically confirmed adenocarcinoma of the prostate
  4. Ongoing therapy with a GnRH agonist or antagonist AND serum testosterone level \<50 ng/dL at screening
  5. Metastatic disease documented by computed tomography (CT)/ magnetic resonance imaging (MRI) or bone scan. Imaging obtained within 42 days prior to the start of study medication will be accepted.

  6. Meeting disease progression according to the recommendations of the prostate cancer working group 2 by one of the following criteria:

    • Two rises of PSA (taken a minimum of 1 week apart) from a baseline measurement of at least 2 ng/mL,
    • Imaging progression (CT/MRI) by RECIST criteria
    • Nuclear scan progression by new lesion.
  7. Discontinuation of flutamide or nilutamide, and other anti-androgens at least 4 weeks prior to the start of study medication; discontinuation of bicalutamide at least 6 weeks prior to start of study medication.
  8. Discontinuation of Radiotherapy > 4 weeks prior to start of study medication.
  9. ECOG performance status of 0-1 at screening

  10. Screening blood counts of the following:

    • Absolute neutrophil count > 1500/µL
    • Platelets > 100,000/µL
    • Hemoglobin > 9 g/dL

  11. Screening chemistry values of the following:

    • ALT and AST \< 2.5 x ULN
    • Total bilirubin \< 1.5 x ULN
    • Creatinine\< 1.5 x ULN
    • Albumin > 3.0 g/dL
  12. Potassium > 3.5 mmol/L
  13. Life expectancy of at least 6 months at screening
  14. Subject is willing and able to comply with all protocol requirements assessments
  15. Agrees to protocol-defined use of effective contraception.

Exclusion criteria

Exclusion Criteria:

  1. History of impaired pituitary or adrenal gland function
  2. Prior therapy with abiraterone acetate, orteronel, ketoconazole or any other CYP17 inhibitor
  3. Prior therapy with enzalutamide
  4. Prior use of experimental androgen receptor antagonist
  5. Previous exposure to Ra-223:Xofigo
  6. Previous chemotherapy
  7. Initiation of bisphosphonate or denosumab therapy within 30 days prior to the start of study medication. Patients who are on a stable dose of these medications for at least 30 days at the time of starting study drug are eligible.
  8. Therapy with estrogen within 30 days prior to the start of study medication
  9. Use of systemic glucocorticoids equivalent to > 10 mg of prednisone daily; patients who have discontinued or have reduced dose to \< 10 mg prednisone within 14 days prior to the start of study medication will be eligible
  10. Prior use of any herbal products that may decrease PSA levels (eg., saw palmetto) within 30 days of start of study medication
  11. Known metastases to the brain or CNS involvement
  12. History of other malignancy within the previous 2 years
  13. Major surgery within 30 days prior to the start of study medication
  14. Blood transfusion within 30 days of screening
  15. Serious, persistent infection within 14 days of the start of study medication
  16. Persistent pain that requires the use of a narcotic analgesic
  17. Known gastrointestinal disease or condition that may impair absorption
  18. Treatment with any investigational drug within 4 weeks prior to Day -1 of the study.
  19. Known history of human immunodeficiency virus (HIV) or seropositive test for hepatitis C virus or hepatitis B virus
  20. Have poorly controlled diabetes.
  21. Uncontrolled hypertension
  22. History of New York Heart Association (NYHA) class III or IV heart failure
  23. Serious concurrent illness, including psychiatric illness, that would interfere with study participation
  24. Inability to swallow tablets whole
  25. Known hypersensitivity to any excipients in study medications
  26. Moderate to severe hepatic impairment (Child-Pugh Classes B and C)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Active comparator
    Zytiga® (Abiraterone Acetate)

    1,000 MG (4 x 250 mg qd)

    Drug: Zytiga® (Abiraterone Acetate)

  • Experimental
    SoluMatrix™ (Abiraterone Acetate)

    500 mg (4 x 125 mg qd)

    Drug: SoluMatrix™ (Abiraterone Acetate)

Interventions

  • DrugZytiga® (Abiraterone Acetate)

    Zytiga® 1,000 mg (4 x 250 mg qd) tablets plus one 5 mg prednisone tablet to be taken bid, spaced approximately 12 hours apart

    Also known as: Zytiga®

  • DrugSoluMatrix™ (Abiraterone Acetate)

    SoluMatrix™ 500 mg (4 x 125 mg qd) tablets plus one 4 mg methylprednisolone tablet bid, spaced approximately 12 hours apart

    Also known as: SoluMatrix™

06

What researchers measure

Primary outcomes

  1. Testosterone Levels

    Blood Sample tested for Serum Testosterone Levels

    Time frame: Average of Day 9 and 10

Secondary outcomes

  1. PSA Levels

    All patients randomized to one of the two treatment groups, round about level of PSA. These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint

    Time frame: Day 28, Day 56, and Day 84

  2. Percent of Subjects With PSA-50 Response

    Proportion of patients with complete suppression of PSA-50 were reported by treatment and compared for between-group differences. These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.

    Time frame: Day 28, Day 56, and Day 84

  3. Serum Testosterone Levels

    These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.

    Time frame: Day 28, Day 56, and Day 84

  4. Steady State Trough Concentration of Arbiraterone

    These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.

    Time frame: Day 09, Day 28, Day 56, and Day 84

  5. AUC (0-inf)

    Steady state systemic exposure parameters

    Time frame: 60 to 30 minutes prior to dosing and over 24 Hours post-dose

  6. AUC (0-24 hr)

    Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).

    Time frame: 60 to 30 minutes prior to dosing and over 24 Hours post-dose

  7. AUC (0-t)

    Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).

    Time frame: 60 to 30 minutes prior to dosing and over 24 Hours post-dose

  8. Cmax

    Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).

    Time frame: 60 to 30 minutes prior to dosing and over 24 Hours post-dose

07

Results

Posted Aug 12, 2020

Participant flow

Participant flow — Overall Study
MilestoneZytiga® (Abiraterone Acetate)SoluMatrix™ (Abiraterone Acetate)
Started2924
Completed2823
Not completed11

Outcome measures

PrimaryTestosterone Levels

Blood Sample tested for Serum Testosterone Levels

Time frame:
Average of Day 9 and 10
Reported as:
Mean · ng/dL
Testosterone Levels
ng/dLZytiga® (Abiraterone Acetate)SoluMatrix™ (Abiraterone Acetate)
Testosterone Levels1.02 ± 0.031.05 ± 0.04
Statistical analysis
  • Zytiga® (Abiraterone Acetate) vs SoluMatrix™ (Abiraterone Acetate) · ANOVA · p = 0.4879 (One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.) · Geometric mean ratio of treatments: 1.019 · 90% CI 0.964 to 1.077Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.
SecondaryPSA Levels

All patients randomized to one of the two treatment groups, round about level of PSA. These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint

Time frame:
Day 28, Day 56, and Day 84
Reported as:
Least squares mean · ng/mL
PSA Levels
ng/mLZytiga® (Abiraterone Acetate)SoluMatrix™ (Abiraterone Acetate)
Day 2837.5 ± 11.3322.37 ± 12.02
Day 5640.84 ± 12.5825.29 ± 13.68
Day 8433.88 ± 13.4326.46 ± 15.41
Statistical analysis
  • Zytiga® (Abiraterone Acetate) vs SoluMatrix™ (Abiraterone Acetate) · ANOVA · p = 0.3642 (One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.) · Geometric mean ratio: 0.994 · 90% CI 0.0451 to 2.192Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.
  • Zytiga® (Abiraterone Acetate) vs SoluMatrix™ (Abiraterone Acetate) · ANOVA · p = 0.4069 (One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.) · Geometric mean ratio: 0.810 · 90% CI 0.338 to 1.939Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.
  • Zytiga® (Abiraterone Acetate) vs SoluMatrix™ (Abiraterone Acetate) · ANOVA · p = 0.7186 (The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.) · Geometric mean ratio: 1.039 · 90% CI 0.412 to 2.617Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.
SecondaryPercent of Subjects With PSA-50 Response

Proportion of patients with complete suppression of PSA-50 were reported by treatment and compared for between-group differences. These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.

Time frame:
Day 28, Day 56, and Day 84
Reported as:
Number · percentage of Participants
Percent of Subjects With PSA-50 Response
percentage of ParticipantsZytiga® (Abiraterone Acetate)SoluMatrix™ (Abiraterone Acetate)
Day 2870.466.7
Day 5665.463.6
Day 8472.068.4
Statistical analysis
  • Zytiga® (Abiraterone Acetate) vs SoluMatrix™ (Abiraterone Acetate) · Fisher Exact · p = 1.0000
SecondarySerum Testosterone Levels

These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.

Time frame:
Day 28, Day 56, and Day 84
Reported as:
Mean · ng/dL
Serum Testosterone Levels
ng/dLZytiga® (Abiraterone Acetate)SoluMatrix™ (Abiraterone Acetate)
Day 281.01 ± 0.011.01 ± 0.01
Day 561.01 ± 1.032.56 ± 1.07
Day 841 ± 01 ± 0
Statistical analysis
  • Zytiga® (Abiraterone Acetate) vs SoluMatrix™ (Abiraterone Acetate) · ANOVA · p = 0.9211 (One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.) · Geometric mean ratio: 0.999 · 90% CI 0.980 to 1.018Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.
  • Zytiga® (Abiraterone Acetate) vs SoluMatrix™ (Abiraterone Acetate) · ANOVA · p = 0.3037 (One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.) · Geometric mean ratio: 1.168 · 90% CI 0.900 to 1.515Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.
  • Zytiga® (Abiraterone Acetate) vs SoluMatrix™ (Abiraterone Acetate) · ANOVA · Geometric mean ratio: 1.000 · 90% CI 1.000 to 1.000Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.
SecondarySteady State Trough Concentration of Arbiraterone

These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.

Time frame:
Day 09, Day 28, Day 56, and Day 84
Reported as:
Least squares mean · ng/dL
Steady State Trough Concentration of Arbiraterone
ng/dLZytiga® (Abiraterone Acetate)SoluMatrix™ (Abiraterone Acetate)
Day 0920.938 ± 7.04427.259 ± 7.772
Day 2856.721 ± 23.10418.662 ± 24.18
Day 5629.978 ± 8.11718.707 ± 9.175
Day 8418.263 ± 3.08713.819 ± 3.381
Statistical analysis
  • Zytiga® (Abiraterone Acetate) vs SoluMatrix™ (Abiraterone Acetate) · ANOVA · p = 0.5495
  • Zytiga® (Abiraterone Acetate) vs SoluMatrix™ (Abiraterone Acetate) · ANOVA · p = 0.2616
  • Zytiga® (Abiraterone Acetate) vs SoluMatrix™ (Abiraterone Acetate) · ANOVA · p = 0.3632
  • Zytiga® (Abiraterone Acetate) vs SoluMatrix™ (Abiraterone Acetate) · ANOVA · p = 0.3393
SecondaryAUC (0-inf)

Steady state systemic exposure parameters

Time frame:
60 to 30 minutes prior to dosing and over 24 Hours post-dose
Reported as:
Least squares mean · ng*hr/mL
AUC (0-inf)
ng*hr/mLZytiga® (Abiraterone Acetate)SoluMatrix™ (Abiraterone Acetate)
AUC (0-inf)1020.218 ± 154.549326.458 ± 218.565
SecondaryAUC (0-24 hr)

Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).

Time frame:
60 to 30 minutes prior to dosing and over 24 Hours post-dose
Reported as:
Least squares mean · ng*hr/mL
AUC (0-24 hr)
ng*hr/mLZytiga® (Abiraterone Acetate)SoluMatrix™ (Abiraterone Acetate)
AUC (0-24 hr)870.859 ± 221.709626.066 ± 280.443
SecondaryAUC (0-t)

Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).

Time frame:
60 to 30 minutes prior to dosing and over 24 Hours post-dose
Reported as:
Least squares mean · ng*hr/mL
AUC (0-t)
ng*hr/mLZytiga® (Abiraterone Acetate)SoluMatrix™ (Abiraterone Acetate)
AUC (0-t)870.859 ± 221.709626.066 ± 280.443
SecondaryCmax

Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).

Time frame:
60 to 30 minutes prior to dosing and over 24 Hours post-dose
Reported as:
Least squares mean · ng/mL
Cmax
ng/mLZytiga® (Abiraterone Acetate)SoluMatrix™ (Abiraterone Acetate)
Cmax268.261 ± 69.967111.316 ± 88.503
Statistical analysis
  • Zytiga® (Abiraterone Acetate) vs SoluMatrix™ (Abiraterone Acetate) · ANOVA · p = 0.1917

Adverse events

Collected over AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Zytiga® (Abiraterone Acetate)2/29 (6.9%)2/29 (6.9%)22/29 (75.9%)
SoluMatrix™ (Abiraterone Acetate)0/24 (0%)5/24 (20.8%)16/24 (66.7%)
Most frequent serious events
Most frequent serious events
EventZytiga® (Abiraterone Acetate)SoluMatrix™ (Abiraterone Acetate)
Corornary artery diseaseCardiac disorders0/291/24
SepsisInfections and infestations0/291/24
PyelonephritisInfections and infestations0/291/24
VertigoInfections and infestations0/291/24
Worsening of left hydroureteronephrosisRenal and urinary disorders0/291/24
Progression of prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/290/24
Myocardial infarctionCardiac disorders1/290/24
Most frequent other events
Showing 10 of 17
Most frequent other events
EventZytiga® (Abiraterone Acetate)SoluMatrix™ (Abiraterone Acetate)
Urinary tract infectionsInfections and infestations3/294/24
Back painMusculoskeletal and connective tissue disorders4/291/24
Muscle spasmsMusculoskeletal and connective tissue disorders4/291/24
DizzinessNervous system disorders4/290/24
NauseaGastrointestinal disorders3/290/24
Abdominal painGastrointestinal disorders0/292/24
Oedema peripheralGeneral disorders0/292/24
VomitingGastrointestinal disorders2/290/24
AstheniaGeneral disorders2/290/24
Blood creatiineincreasedInvestigations2/290/24

Baseline characteristics

Age, Continuous
Age, Continuous(years)Zytiga® (Abiraterone Acetate)SoluMatrix™ (Abiraterone Acetate)Total
Mean73.5 ± 9.477 ± 8.975.1 ± 9.3
Sex: Female, Male
Sex: Female, Male(Participants)Zytiga® (Abiraterone Acetate)SoluMatrix™ (Abiraterone Acetate)Total
Female000
Male292453
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Zytiga® (Abiraterone Acetate)SoluMatrix™ (Abiraterone Acetate)Total
Hispanic or Latino246
Not Hispanic or Latino272047
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Zytiga® (Abiraterone Acetate)SoluMatrix™ (Abiraterone Acetate)Total
American Indian or Alaska Native000
Asian011
Native Hawaiian or Other Pacific Islander000
Black or African American8311
White202040
More than one race000
Unknown or Not Reported101
Region of Enrollment
Region of Enrollment(participants)Zytiga® (Abiraterone Acetate)SoluMatrix™ (Abiraterone Acetate)Total
United States292453
08

Study locations

17 sites
  • Alliance Research
    Laguna Hills, California 92653, United States
  • Tower Urology
    Los Angeles, California 90048, United States
  • San Bernardino Urological
    San Bernardino, California 92404, United States
  • Skyline Urology
    Torrance, California 90505, United States
  • Innovative Clinical Research Institute
    Whittier, California 90603, United States
  • Urology Associates, P.C.
    Englewood, Colorado 80113, United States
  • Manatee Medical Research
    Bradenton, Florida 34205, United States
  • North Idaho Urology
    Coeur d'Alene, Idaho 83814, United States
  • The Iowa Clinic
    West Des Moines, Iowa 50266, United States
  • Wichita Urology Group
    Wichita, Kansas 67226, United States
  • Chesapeake Urology Research Associates
    Towson, Maryland 21204, United States
  • Lincoln Urology, PC
    Lincoln, Nebraska 68516, United States
  • Urology Cancer Center
    Omaha, Nebraska 68130, United States
  • Brooklyn Urology Research Group
    Brooklyn, New York 11215, United States
  • Associated Urologist of North Carolina
    Raleigh, North Carolina 27612, United States
  • Urology Clinics of North Texas
    Dallas, Texas 75231, United States
  • Urology of Virginia
    Virginia Beach, Virginia 23462, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 10, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02737332
Lead sponsor
Sun Pharmaceutical Industries Limited
Responsible party
Sponsor
First posted
Apr 13, 2016
Start date
Mar 21, 2016
Primary completion
Feb 27, 2017
Completion
Feb 27, 2017
Results posted
Aug 12, 2020
Last update
Nov 22, 2021

Study contacts

Paul Nemeth, PhD
study director

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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