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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
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)
The study will require that 50% of enrolled subjects have homozygous deletions, deleterious mutations, or both in one or more of the DNA damage response (DDR) genes; the other 50% of patients must have an intact DDR pathway
Must not have
Any previous treatment with poly-adenosine diphosphate ribose polymerase (PARP) inhibitor, including olaparib
Other malignancy unless curatively treated with no evidence of disease for ≥ 5 years except: adequately treated non-melanoma skin cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years after initiating therapy
Awards & highlights
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 belowSelect...
My prostate cancer is growing despite low testosterone levels.
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My cancer has specific genetic changes or my genetic makeup for cancer repair is normal.
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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 prostate cancer has been confirmed through a biopsy.
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I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have never been treated with PARP inhibitors like olaparib.
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I've been cancer-free for 5 years, except for non-melanoma skin cancer.
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I had a blood clot in my veins or lungs in the last 5 years and am not on blood thinners.
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I have severe heart failure or had a heart attack before joining the study.
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I have pain caused by my prostate cancer.
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I have lasting side effects from cancer treatment, but not hair loss.
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I cannot swallow pills or have stomach issues affecting medicine absorption.
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I do not have active hepatitis B or C.
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I have had a bone marrow or cord blood transplant in the past.
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I haven't had chemotherapy or radiotherapy (except for comfort care) in the last 3 weeks.
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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.
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I had major surgery more than 2 weeks ago and have recovered from it.
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I do not have any severe, uncontrolled health conditions that could make me a high medical risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years after initiating therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years after initiating therapy
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 moreTrial 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
~2210
Testosterone Cypionate
2011
Completed Phase 2
~150
Testosterone Enanthate
2002
Completed Phase 4
~700
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,365 Total Patients Enrolled
566 Trials studying Prostate Cancer
529,005 Patients Enrolled for Prostate Cancer
AstraZenecaIndustry Sponsor
4,302 Previous Clinical Trials
288,624,563 Total Patients Enrolled
60 Trials studying Prostate Cancer
27,522 Patients Enrolled for Prostate Cancer
University of WashingtonLead Sponsor
1,762 Previous Clinical Trials
1,876,446 Total Patients Enrolled
18 Trials studying Prostate Cancer
8,244 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never been treated with PARP inhibitors like olaparib.I've been cancer-free for 5 years, except for non-melanoma skin cancer.I had a blood clot in my veins or lungs in the last 5 years and am not on blood thinners.I have severe heart failure or had a heart attack before joining the study.I have pain caused by my prostate cancer.My cancer causes blockage that makes me need a catheter to urinate.My prostate cancer is growing despite low testosterone levels.I am willing and able to follow the study's treatment plan and attend all visits.My cancer has specific genetic changes or my genetic makeup for cancer repair is normal.I am not taking strong or moderate drugs that affect liver enzymes, or I can stop them for 2 weeks before starting olaparib.I have stopped taking certain strong or moderate drugs that affect how other medications work for the required time before starting olaparib.I have lasting side effects from cancer treatment, but not hair loss.I cannot swallow pills or have stomach issues affecting medicine absorption.I do not have active hepatitis B or C.I have had a bone marrow or cord blood transplant in the past.I have not had a whole blood transfusion in the last 120 days.My cancer's location puts me at risk if I receive testosterone therapy.My cancer progressed after treatment with abiraterone or enzalutamide, and it's been 3 weeks since I last took them.I haven't had chemotherapy or radiotherapy (except for comfort care) in the last 3 weeks.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I haven't had chemotherapy for metastatic castration-resistant prostate cancer, but may have had docetaxel for hormone-sensitive cancer.I have not taken any experimental cancer drugs in the last 3 weeks.I have at least one cancer lesion that can be measured by scans like CT, PET, MRI, or bone scan.I can provide tissue samples or undergo a biopsy for DNA testing.My prostate cancer has been confirmed through a biopsy.My hemoglobin level is at least 10.0 g/dL and I haven't had a blood transfusion in the last 28 days.My kidney function, measured by creatinine clearance, is adequate.I am fully active or can carry out light work.I am a man who will use two effective birth control methods during and 3 months after the study.I don't have uncontrolled brain metastases or spinal cord compression, or they are stable after treatment.I had major surgery more than 2 weeks ago and have recovered from it.My liver function tests are within the required range.I do not have any severe, uncontrolled health conditions that could make me a high medical risk.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (olaparib, testosterone enanthate or cypionate)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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