Olaparib for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Prostate Cancer+3 More
Olaparib - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial looks at using testosterone and olaparib to treat prostate cancer that has progressed despite hormonal therapy.

Eligible Conditions
  • Prostate Cancer
  • Adenocarcinoma
  • Castration-Resistant Prostate Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 13 Secondary · Reporting Duration: Up to 2 years

Year 2
PSA Progression Free Survival (PFS)
PSA progression free survival (PFS)
Week 22
Percent of Patients With a Prostate-specific Antigen (PSA) Decline of at Least 50% Below Baseline PSA50 Response Rate
Week 12
Prostate
Average change in quality of life (QOL) assessed by the International Index of Erectile Function (IIEF) survey
Percent of patients with a prostate-specific antigen (PSA) decline of at least 50% below baseline PSA50 response rate
Up to 2 years
Overall Survival (OS)
Overall survival (OS)
PSA50 response rate (i.e. decline in PSA ≥ 50% from baseline)
Radiographic PFS
Radiographic Response Rate
Radiographic response rate
Year 2
Average Change in Quality of Life (QOL) Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Survey
Average Change in Quality of Life (QOL) Assessed by the International Index of Erectile Function (IIEF) Survey
Day 30
Incidence of Adverse Events (AEs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03
Incidence of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Treatment (olaparib, testosterone enanthate or cypionate)
1 of 1

Experimental Treatment

36 Total Participants · 1 Treatment Group

Primary Treatment: Olaparib · No Placebo Group · Phase 2

Treatment (olaparib, testosterone enanthate or cypionate)Experimental Group · 6 Interventions: Olaparib, Quality-of-Life Assessment, Laboratory Biomarker Analysis, Survey Administration, Testosterone Cypionate, Testosterone Enanthate · Intervention Types: Drug, Other, Other, Other, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
FDA approved
Testosterone cypionate
FDA approved
Testosterone enanthate
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,587 Previous Clinical Trials
1,567,187 Total Patients Enrolled
18 Trials studying Prostate Cancer
8,244 Patients Enrolled for Prostate Cancer
AstraZenecaIndustry Sponsor
3,960 Previous Clinical Trials
91,810,147 Total Patients Enrolled
57 Trials studying Prostate Cancer
26,277 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,000 Previous Clinical Trials
41,300,871 Total Patients Enrolled
534 Trials studying Prostate Cancer
502,333 Patients Enrolled for Prostate Cancer
Michael T. SchweizerPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
A patient must have evidence of castration resistant prostate cancer, as evidenced by PSA progression according to the PCWG3 criteria, and a castrate serum testosterone level, i.e., less than 50 mg/dL.
with apalutamide Patients must have progressed on previous hormonal therapies (abiraterone and/or enzalutamide); there must be at least a 3-week washout period after stopping the most recent approved therapy for mCRPC (i.e., abiraterone, enzalutamide, Ra-223, sipuleucel-t); if applicable, patients should be weaned off steroids at least 1 week prior to starting treatment with apalutamide.
The patient must have an ANC of at least 1.5 x 10^9/L within 28 days prior to receiving the study drug.
A platelet count of at least 100 x 10^9/L within 28 days prior to administration of study treatment is required.
In order to participate in the study, you must be willing to sign a consent form that states that you understand the risks and benefits of the study specific procedures.
gland is an uncommon disease, with a prevalence of 1% in the United States
You have a PSA of at least 1 ng/ml and rising on two successive measurements at least two weeks apart.
before starting study drug The subject may have received prior treatment with non-chemotherapy investigational agents, but must have had at least a 3-week washout period after stopping any investigational cancer agent before starting study drug.
The person must have a hemoglobin level of at least 10.0 g/dL and have not received a blood transfusion in the past 28 days in order to participate in the study.
There is no prior chemotherapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC); patients may have received docetaxel for the treatment of hormone-sensitive prostate cancer.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: November 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.