BrUOG 337: Olaparib Prior to Radical Prostatectomy For Patients With Locally Advanced Prostate Cancer and Defects in DNA Repair Genes (337)
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|ClinicalTrials.gov Identifier: NCT03432897|
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : May 29, 2018
This study will evaluate approximately 3 months of treatment with the drug olaparib in patients with prostate cancer. A capsule formulation of olaparib (tradename Lynparza™) is approved by the United States Food and Drug Administration (FDA) for the treatment of women with advanced BRCA-mutated ovarian cancer. Olaparib is an investigational drug in prostate cancer. A tablet formulation of olaparib is being tested in this study. It is a new formulation which is more convenient for patients than the approved capsule formulation because fewer tablets of olaparib need to be taken daily than with capsules.
The purpose of the study is to evaluate whether olaparib can reduce prostate cancer with defects in DNA repair genes when olaparib is given for approximately 3 months before surgery.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Adenocarcinoma of the Prostate||Drug: Olaparib Pill Procedure: Prostatectomy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||BrUOG 337: Olaparib Prior to Radical Prostatectomy For Patients With Locally Advanced Prostate Cancer and Defects in DNA Repair Genes|
|Actual Study Start Date :||May 25, 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2021|
Olaparib 300 mg BID q 4 weeks for up to 3 cycles. The 3rd cycle will not be given if patient is found to progress post cycle 2.
Between 22-42 days post Olaparib, patients will undergo a prostatectomy.
Drug: Olaparib Pill
300 mg BID
22-42 days post Olaparib patients will undergo surgery
- Prostate Specific Antigen (PSA) response rate of olaparib prior to radical prostatectomy for patients with locally advanced prostate cancer and defects in DNA repair genes. [ Time Frame: Throughout the trial for approximately 2 years ]
Response:Reduction of at least 50% in the prostate-specific antigen level from baseline Progression:A 25% increase in PSA from baseline
Baseline then approximately 8 weeks later and 2 weeks post Olaparib, approximately 10-14 weeks after baseline and then approximately every 6 months for 2 years in follow-up.
- Evaluate the PSA progression-free survival of olaparib and radical prostatectomy for patients with locally advanced prostate cancer and defects in DNA repair genes. [ Time Frame: Post treatment (approximately 8-12 weeks) and approximately every 6 months for 2 years. ]Evaluation by treating physician
- Evaluate the safety of olaparib prior to radical prostatectomy for patients with locally advanced prostate cancer [ Time Frame: Baseline, prior to each cycle (approximately every 4 weeks) for up to 3 cycles, 2 weeks post treatment, and 30 days post drug and post surgery for a total of approximately 5-6 months ]CTCAE 4.03
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432897
|Contact: kayla rosati, EdMfirstname.lastname@example.org|
|United States, Rhode Island|
|Lifespan Cancer Institute: The Miriam and Rhode Island Hospitals||Recruiting|
|Providence, Rhode Island, United States, 02903|
|Contact: Kayla Rosati, EdM 401-863-3000 email@example.com|
|Principal Investigator: Anothony Mega, MD|
|Principal Investigator:||Anthony Mega, MD||BrUOG|