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PARP Inhibitor

Testosterone + Olaparib for Prostate Cancer

Phase 2
Waitlist Available
Led By Michael T. Schweizer
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented histologically confirmed adenocarcinoma of the prostate
Patient must have evidence of castration resistant prostate cancer as evidenced by PSA progression (per Prostate Cancer Working Group 3 [PCWG3] criteria) and a castrate serum testosterone level (i.e., ≤ 50 mg/dL)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years after initiating therapy
Awards & highlights
No Placebo-Only Group

Study Summary

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

Who is the study for?
Men with castration-resistant prostate cancer, who have progressed on treatments like abiraterone or enzalutamide and haven't had chemotherapy for metastatic cancer. They must be expected to live at least 16 weeks, have a testosterone level ≤ 50 mg/dL, rising PSA levels, good organ function, and no recent participation in other clinical trials. Men must agree to use two forms of contraception and could have certain heart conditions or other cancers excluded.Check my eligibility
What is being tested?
The trial is testing the combination of testosterone (either enanthate or cypionate) with olaparib in men whose prostate cancer has worsened despite hormonal therapy. The goal is to see if this combo can better damage the DNA of cancer cells that are resistant to low testosterone environments.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, vomiting, anemia (low red blood cell count), potential cardiac issues due to testosterone treatment such as increased risk of heart attack or stroke, digestive problems from olaparib including diarrhea and indigestion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer has been confirmed through a biopsy.
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My prostate cancer is growing despite low testosterone levels.
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My cancer progressed after treatment with abiraterone or enzalutamide, and it's been 3 weeks since I last took them.
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I haven't had chemotherapy for metastatic castration-resistant prostate cancer, but may have had docetaxel for hormone-sensitive cancer.
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I have not taken any experimental cancer drugs in the last 3 weeks.
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My hemoglobin level is at least 10.0 g/dL and I haven't had a blood transfusion in the last 28 days.
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My liver function tests are within the required range.
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My kidney function, measured by creatinine clearance, is adequate.
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I am fully active or can carry out light work.
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I am a man who will use two effective birth control methods during and 3 months after the study.
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I am willing and able to follow the study's treatment plan and attend all visits.
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I have at least one cancer lesion that can be measured by scans like CT, PET, MRI, or bone scan.
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I can provide tissue samples or undergo a biopsy for DNA testing.
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My cancer has specific genetic changes or my genetic makeup for cancer repair is normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years after initiating therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years after initiating therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of Patients With a Prostate-specific Antigen (PSA) Decline of at Least 50% Below Baseline PSA50 Response Rate
Secondary outcome measures
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
Incidence of Adverse Events (AEs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (olaparib, testosterone enanthate or cypionate)Experimental Treatment6 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140
Testosterone Cypionate
2011
Completed Phase 1
~110
Testosterone Enanthate
2002
Completed Phase 4
~670

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,574 Previous Clinical Trials
41,224,140 Total Patients Enrolled
559 Trials studying Prostate Cancer
506,278 Patients Enrolled for Prostate Cancer
AstraZenecaIndustry Sponsor
4,218 Previous Clinical Trials
289,739,363 Total Patients Enrolled
60 Trials studying Prostate Cancer
27,488 Patients Enrolled for Prostate Cancer
University of WashingtonLead Sponsor
1,718 Previous Clinical Trials
1,818,396 Total Patients Enrolled
18 Trials studying Prostate Cancer
8,244 Patients Enrolled for Prostate Cancer

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03516812 — Phase 2
Prostate Cancer Research Study Groups: Treatment (olaparib, testosterone enanthate or cypionate)
Prostate Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT03516812 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03516812 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scale of this experiment in terms of participant recruitment?

"This trial is no longer enrolling participants. The initial posting occurred on August 29th, 2018 and the most recent edit was October 19th, 2022. If you're searching for other clinical trials to consider, 1965 studies are actively looking for prostate cancer patients and 223 trials require individuals taking Olaparib."

Answered by AI

What is the primary aim of this experiment?

"The primary endpoint tracked over 12 weeks is the Prostate-specific Antigen (PSA) decline of 50% or more below baseline. Secondary endpoints include PSA progression free survival as per criteria from the Prostate cancer Working Group 3, Radiographic response rate utilizing RECIST 1.1 guidelines, and Overall Survival measured with Kaplan Meier curves. Best on study PSA results will be charted in a waterfall plot while rates will be presented as percentages alongside 95% CI estimations."

Answered by AI

Are there vacancies remaining in this clinical trial?

"According to clinicaltrials.gov, this particular clinical trial is currently not seeking participants as the last update was on October 19th 2022. However, there are a plethora of other trials actively recruiting at present with over two thousand one hundred and eighty-eight open studies."

Answered by AI

What ailments does Olaparib typically address?

"Olaparib is commonly used to manage testicular hypogonadism, but it can also provide relief from primary peritoneal cancer, hallucinations, somatic issues and deficiencies caused by a lack of gonadotrophin releasing hormones."

Answered by AI

Has Olaparib gained sanctioning from the FDA?

"Olaparib's safety was assessed to be a 2, as this Phase 2 trial has produced data demonstrating its security but not yet proof of efficacy."

Answered by AI

Has Olaparib been tested in other experimental trials?

"Currently, 223 studies on Olaparib are being conducted and 32 of those experiments have advanced to Phase 3. Despite most research occurring in Phoenix, Arizona, there is an expansive network of 9388 locations worldwide trialing this potential cure."

Answered by AI
~6 spots leftby Feb 2025