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Talazoparib + Enzalutamide for Metastatic Prostate Cancer
Study Summary
This trial is testing a new combination of drugs to treat men with aggressive prostate cancer that has spread and who have a specific genetic mutation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have a history of MDS, AML, or another cancer, with some exceptions.You have not participated in any experimental medical treatments for at least four weeks before the study.I have a serious heart condition.I have not been treated with docetaxel for my prostate cancer.I do not have any health or mental conditions that would stop me from joining the study.I have not had NHT treatment, except as allowed in a specific case.I am willing and able to follow all study requirements.I haven't had chemotherapy that damages DNA for conditions other than prostate cancer in the last 5 years.My organs are functioning well enough for treatment.I have brain metastasis or active leptomeningeal disease.I am fully active or can carry out light work.I am experiencing symptoms related to spinal cord pressure.I have never been treated with PARPi and am not allergic to enzalutamide or talazoparib.My prostate cancer is confirmed and does not have certain aggressive features.I am willing to give a sample of my tumor for further testing.I have not had major surgery in the last 4 weeks.I have a stomach or intestine problem that affects how my body absorbs food.I currently have COVID-19.My prostate cancer has spread, confirmed by scans.I am currently taking estrogens, cyproterone acetate, or first-generation anti-androgens.I am able to understand and sign the consent form.I have had hormone therapy for cancer as part of my initial treatment.I have had radiation or surgery for symptom relief from prostate cancer.I have taken more than 10 mg of prednisone or similar daily in the last 4 weeks.I haven't taken strong P-gp inhibitors in the last week.I have a history of seizures or conditions that could lead to seizures.I am a man over the age of 18 (20 in Japan, 19 in Korea).My cancer has a DDR gene mutation confirmed by a specific test.I agree to give a saliva sample for genetic testing.I agree to use a condom and another effective birth control method if I'm sexually active.I have had ≤3 months of hormone therapy for my prostate cancer.I am currently on hormone therapy for cancer and have not had both testicles removed.
- Group 1: Arm 1
- Group 2: Arm 2
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Are there a significant number of hospitals participating in this clinical trial within the state?
"In addition to the Willis Knighton Advanced Urology in Shreveport, Louisiana, David C. Pratt Cancer Center in Saint Louis, Missouri, and CIUSSS- saguenay-Lac-Saint-Jean in Chicoutimi, Quebec; this study is also running out of 60 other locations."
Are there precedent studies which have looked at talazoparib in combination with enzalutamide?
"The first study investigating talazoparib plus enzalutamide was completed in 2005 at Rosemere Cancer Centre. As of now, there have been 107 similar studies conducted with 160 more presently underway. A large portion of these active trials are based out Shreveport, Louisiana."
Has the FDA sanctioned talazoparib in combination with enzalutamide?
"Talazoparib plus enzalutamide is considered safe by our team at Power. This is a Phase 3 trial, so there is some evidence of efficacy and the safety has been verified in multiple rounds of testing."
How many people are included in this clinical trial?
"In order to properly conduct this trial, 550 eligible patients must be recruited. Patients can register for the trial at Willis Knighton Advanced Urology in Shreveport or David C. Pratt Cancer Center in Saint Louis."
Are new participants being recruited for this experiment?
"Based on the information available on clinicaltrials.gov, it appears as though this study is still recruiting patients. The trial was established on May 12th, 2021 and updated October 26th, 2022. There are 60 sites enrolling a total of 550 participants."
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