Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years after initiating therapy
Awards & highlights
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 belowSelect...
My prostate cancer is growing despite low testosterone levels.
Select...
My cancer has specific genetic changes or my genetic makeup for cancer repair is normal.
Select...
I have at least one cancer lesion that can be measured by scans like CT, PET, MRI, or bone scan.
Select...
I can provide tissue samples or undergo a biopsy for DNA testing.
Select...
My prostate cancer has been confirmed through a biopsy.
Select...
I am fully active or can carry out light work.
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
~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
13,654 Previous Clinical Trials
40,933,117 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 Patients Enrolled for Prostate Cancer
AstraZenecaIndustry Sponsor
4,257 Previous Clinical Trials
288,593,750 Total Patients Enrolled
60 Trials studying Prostate Cancer
27,522 Patients Enrolled for Prostate Cancer
University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,315 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.
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
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger