Study on Olaparib for Men with High-Risk Prostate Cancer After Surgery, Including Biomarker Analysis
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials ID:NCT03047135
This clinical trial is testing the effectiveness of the drug Olaparib in men with high-risk prostate cancer that has returned after surgery. The study will also analyze specific biomarkers to understand how the drug works in these patients.
Patient Parameters
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Program Overview
Olaparib has shown promise in treating advanced prostate cancer that no longer responds to standard hormone therapy. In a previous study, some patients experienced a reduction in PSA levels, which is a marker of prostate cancer activity. Many of these patients had mutations in genes responsible for DNA repair. This study aims to explore the use of Olaparib earlier in the treatment process for prostate cancer, rather than waiting until the disease is more advanced. The study will also look at how Olaparib affects other processes in prostate cancer cells, such as the regulation of the androgen receptor, which is important for cancer growth.
Description
This study is a Phase II trial where all participants will receive the same treatment. It is open to men with prostate cancer that has returned after surgery but has not spread to other parts of the body. Participants must have a PSA doubling time of 6 months or less and a PSA level of at least 1.0.
Participants will take Olaparib tablets twice a day. They will have monthly clinic visits for safety checks, blood tests, and PSA measurements. Treatment will continue until the PSA level doubles, cancer spreads, or side effects require stopping the drug. Scans will be done every 6 months to check for cancer spread.
The study will include up to 50 participants. It will start with a group of 20 men to see how many respond to the treatment. If enough men respond, more participants will be added. The study will also look at specific gene mutations to see if they affect how well Olaparib works.
Eligibility Criteria
Inclusion Criteria
- Men diagnosed with prostate cancer.
- Have had surgery to remove the prostate, with tissue available for testing.
- May have had radiation therapy, but it must have been completed at least 6 months ago.
- PSA level of at least 1 ng/ml.
- PSA doubling time of 6 months or less, based on recent tests.
- No signs of cancer spread on recent scans.
- Normal testosterone levels.
- Normal blood and organ function based on recent tests.
- Good overall health, able to carry out normal activities.
- Agree to use effective birth control during and after the study.
- For certain stages of the study, confirmation of specific gene mutations may be required.
Exclusion Criteria
- Recent hormone therapy within the last 6 months.
- Recent use of certain prostate cancer medications.
- Previous chemotherapy treatment.
- Involvement in planning or conducting the study.
- Participation in another clinical trial recently.
- Previous treatment with PARP inhibitors like Olaparib.
- Certain heart conditions or family history of long QT syndrome.
- Use of certain medications that interact with Olaparib.
- Blood disorders like myelodysplastic syndrome or leukemia.
- Recent major surgery.
- Serious uncontrolled medical conditions.
- Difficulty swallowing pills or gastrointestinal issues affecting absorption.
- Immunocompromised status, such as HIV positive.
- Allergies to Olaparib or its ingredients.
- Active hepatitis infection.
- Recent whole blood transfusions.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Johns Hopkins Hospital | 21231 | Baltimore | Maryland |
| University of Nebraska Medical Center | 68198 | Omaha | Nebraska |
| Thomas Jefferson University | 19107 | Philadelphia | Pennsylvania |
| Allegheny Cancer Center | 15212 | Pittsburgh | Pennsylvania |
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