Trial Outcomes & Findings for Testosterone and Olaparib in Treating Patients With Castration-Resistant Prostate Cancer (NCT NCT03516812)
NCT ID: NCT03516812
Last Updated: 2025-09-29
Results Overview
PSA response will be defined as a decline in PSA ≥ 50% compared to baseline in patients who received at least 12 weeks of treatment. Will be calculated as the percentage with 95% confidence interval (CI) of the total number of subjects that achieved a PSA response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Median time to PSA50 response was 22 weeks.
Results posted on
2025-09-29
Participant Flow
Participant milestones
| Measure |
Treatment (olaparib, testosterone enanthate or cypionate)
Patients receive olaparib PO BID on days 1-28 and testosterone enanthate or cypionate IM on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Survey Administration: Ancillary studies
Testosterone Enanthate: Given IM
Testosterone Cypionate: Given IM
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Treatment (olaparib, testosterone enanthate or cypionate)
Patients receive olaparib PO BID on days 1-28 and testosterone enanthate or cypionate IM on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Survey Administration: Ancillary studies
Testosterone Enanthate: Given IM
Testosterone Cypionate: Given IM
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Lack of Efficacy
|
2
|
Baseline Characteristics
Testosterone and Olaparib in Treating Patients With Castration-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Treatment (olaparib, testosterone enanthate or cypionate)
n=36 Participants
Patients receive olaparib PO BID on days 1-28 and testosterone enanthate or cypionate IM on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Survey Administration: Ancillary studies
Testosterone Enanthate: Given IM
Testosterone Cypionate: Given IM
|
|---|---|
|
Age, Continuous
|
70.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
|
PSA
|
25.6 ng/ml
n=5 Participants
|
|
Prior abiraterone treatment
|
25 Participants
n=5 Participants
|
|
Prior enzalutamide treatment
|
18 Participants
n=5 Participants
|
|
Prior docetaxel treatment
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Median time to PSA50 response was 22 weeks.Population: Includes patient that received at least 12 weeks of treatment.
PSA response will be defined as a decline in PSA ≥ 50% compared to baseline in patients who received at least 12 weeks of treatment. Will be calculated as the percentage with 95% confidence interval (CI) of the total number of subjects that achieved a PSA response.
Outcome measures
| Measure |
Treatment (olaparib, testosterone enanthate or cypionate)
n=30 Participants
Patients receive olaparib PO BID on days 1-28 and testosterone enanthate or cypionate IM on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Survey Administration: Ancillary studies
Testosterone Enanthate: Given IM
Testosterone Cypionate: Given IM
|
|---|---|
|
Percent of Patients With a Prostate-specific Antigen (PSA) Decline of at Least 50% Below Baseline PSA50 Response Rate
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after last dose, 19 month medianNumber of patients experiencing an adverse event
Outcome measures
| Measure |
Treatment (olaparib, testosterone enanthate or cypionate)
n=36 Participants
Patients receive olaparib PO BID on days 1-28 and testosterone enanthate or cypionate IM on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Survey Administration: Ancillary studies
Testosterone Enanthate: Given IM
Testosterone Cypionate: Given IM
|
|---|---|
|
Incidence of Adverse Events (AEs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03
|
33 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPer the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines, a radiographic response (as determined on CT or MRI) will be defined as: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (olaparib, testosterone enanthate or cypionate)
n=13 Participants
Patients receive olaparib PO BID on days 1-28 and testosterone enanthate or cypionate IM on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Survey Administration: Ancillary studies
Testosterone Enanthate: Given IM
Testosterone Cypionate: Given IM
|
|---|---|
|
Radiographic Response Rate
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years following the last dose of study drug, median of 20 monthsMedian time to PSA progression free survival in months with 95% CI
Outcome measures
| Measure |
Treatment (olaparib, testosterone enanthate or cypionate)
n=36 Participants
Patients receive olaparib PO BID on days 1-28 and testosterone enanthate or cypionate IM on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Survey Administration: Ancillary studies
Testosterone Enanthate: Given IM
Testosterone Cypionate: Given IM
|
|---|---|
|
PSA Progression Free Survival (PFS)
|
7 months
Interval 4.0 to 11.0
|
SECONDARY outcome
Timeframe: Up to 2 years following the last dose of study drug, median 29 monthsMedian overall survival in months with 95% CI will be calculated.
Outcome measures
| Measure |
Treatment (olaparib, testosterone enanthate or cypionate)
n=36 Participants
Patients receive olaparib PO BID on days 1-28 and testosterone enanthate or cypionate IM on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Survey Administration: Ancillary studies
Testosterone Enanthate: Given IM
Testosterone Cypionate: Given IM
|
|---|---|
|
Overall Survival (OS)
|
26 months
Interval 22.0 to 99999.0
|
SECONDARY outcome
Timeframe: Up to 2 years following the last dose of study drug, median 19 monthsMedian radiographic progression free survival in months with 95% CI.
Outcome measures
| Measure |
Treatment (olaparib, testosterone enanthate or cypionate)
n=36 Participants
Patients receive olaparib PO BID on days 1-28 and testosterone enanthate or cypionate IM on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Survey Administration: Ancillary studies
Testosterone Enanthate: Given IM
Testosterone Cypionate: Given IM
|
|---|---|
|
Radiographic PFS
|
13 months
Interval 7.0 to 17.0
|
SECONDARY outcome
Timeframe: From baseline and up to 5 years after initiating therapy, median 19 monthsPopulation: Number of patients who completed FACT-P QOL survey after 4 cycles of treatment.
Average change in total Functional Assessment of Cancer Therapy-Prostate (FACT-P) quality of life (QOL) score after 4 cycles of treatment. FACT-P is a validated survey designed to assess the QOL in patients with prostate cancer. The FACT-P contains 39 items that use a 0-4 rating scale. The highest possible score is 156 (lowest possible score = 0). The total score is an indication of overall quality of life, where the higher scores indicate better quality of life.Score is reported as units on a scale.
Outcome measures
| Measure |
Treatment (olaparib, testosterone enanthate or cypionate)
n=22 Participants
Patients receive olaparib PO BID on days 1-28 and testosterone enanthate or cypionate IM on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Survey Administration: Ancillary studies
Testosterone Enanthate: Given IM
Testosterone Cypionate: Given IM
|
|---|---|
|
Average Change in Quality of Life (QOL) Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Survey
|
1.36 Mean differences in score
Interval -4.89 to 7.33
|
SECONDARY outcome
Timeframe: Up to 5 years after initiating therapy, median 19 monthsPopulation: Number of patients who completed IIEF QOL survey after 4 cycles of treatment.
Participants were assessed using the International Index of Erectile Function (IIEF) which is a validated multidimensional scale for erectile function and ejaculatory function in men. The questionnaire consists of 3 questions with a scale for each from 0-5 (highest overall score 15, lowest score 0). The higher the score, the better the outcome and vice versa. Score is reported as units on a scale.
Outcome measures
| Measure |
Treatment (olaparib, testosterone enanthate or cypionate)
n=22 Participants
Patients receive olaparib PO BID on days 1-28 and testosterone enanthate or cypionate IM on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Survey Administration: Ancillary studies
Testosterone Enanthate: Given IM
Testosterone Cypionate: Given IM
|
|---|---|
|
Average Change in Quality of Life (QOL) Assessed by the International Index of Erectile Function (IIEF) Survey
|
2.56 Mean differences in score
Interval -0.93 to 6.04
|
Adverse Events
Treatment (olaparib, testosterone enanthate or cypionate)
Serious events: 5 serious events
Other events: 33 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Treatment (olaparib, testosterone enanthate or cypionate)
n=36 participants at risk
Patients receive olaparib PO BID on days 1-28 and testosterone enanthate or cypionate IM on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Survey Administration: Ancillary studies
Testosterone Enanthate: Given IM
Testosterone Cypionate: Given IM
|
|---|---|
|
Nervous system disorders
Subdural hematoma
|
2.8%
1/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Cardiac disorders
Myocardial infarction
|
2.8%
1/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Musculoskeletal and connective tissue disorders
Rib fracture
|
2.8%
1/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Nervous system disorders
Stroke
|
2.8%
1/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Nervous system disorders
Cord compression
|
2.8%
1/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
Other adverse events
| Measure |
Treatment (olaparib, testosterone enanthate or cypionate)
n=36 participants at risk
Patients receive olaparib PO BID on days 1-28 and testosterone enanthate or cypionate IM on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Survey Administration: Ancillary studies
Testosterone Enanthate: Given IM
Testosterone Cypionate: Given IM
|
|---|---|
|
General disorders
Fatigue
|
58.3%
21/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Gastrointestinal disorders
Nausea
|
50.0%
18/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
General disorders
Pain
|
36.1%
13/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Gastrointestinal disorders
Constipation
|
22.2%
8/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Blood and lymphatic system disorders
Anemia
|
19.4%
7/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Metabolism and nutrition disorders
Anorexia
|
19.4%
7/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
6/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Nervous system disorders
Dysgeusia
|
13.9%
5/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Renal and urinary disorders
Creatinine increase
|
11.1%
4/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
4/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
3/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Nervous system disorders
Dizziness or Lightheadedness
|
8.3%
3/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Renal and urinary disorders
Nocturia
|
8.3%
3/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Metabolism and nutrition disorders
Weight loss
|
8.3%
3/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
2/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Blood and lymphatic system disorders
Edema
|
5.6%
2/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.6%
2/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Nervous system disorders
Insomnia
|
5.6%
2/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Nervous system disorders
Memory impairment
|
5.6%
2/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Vascular disorders
Thromboembolic event
|
5.6%
2/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
|
Renal and urinary disorders
Urinary retention
|
5.6%
2/36 • Serious and other AEs assessed for up to 2 years and within 30 days of stopping study drugs, median 19 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place