TALAPRO-2: A Study Assessing the Study Drug + Enzalutamide vs. Placebo + Enzalutamide in Men With Metastatic Castration Resistant Prostate Cancer (mCRPC) and DNA Damage Repair (DDR) Deficiency
TALAPRO-2: A study Assessing the Study Drug + Enzalutamide vs. Placebo + Enzalutamide in Men with Metastatic Castration Resistant Prostate Cancer (mCRPC) and DNA Damage Repair (DDR) Deficiency
About the Study
TALAPRO-2 is a study for men who have been diagnosed with metastatic castration-resistant prostate cancer (mCRPC) which means that hormone therapies, one of the main treatment options for this type of cancer, have no effect and the tumor has spread to other parts of the body.
This research study is investigating if a study drug called talazoparib, is safe and effective when given alongside enzalutamide, an existing, approved treatment for metastatic prostate cancer.
Type of Study
This is a Phase 3, randomized, double blind, placebo-controlled study. The goal is to assess if talazoparib (the study drug) plus enzalutamide is safe and more effective than enzalutamide alone in helping to delay the spread of cancer.
- The study is placebo-controlled. Placebos are inactive ingredients; it is normal in clinical research like this to measure results against a placebo in order to be sure that the study drug is responsible for any effects seen
- Participants will be randomized into two different treatment groups. One will be given talazoparib (the study drug) and enzalutamide, while the other group will receive a placebo and enzalutamide.
- This is a double-blind study, which means neither the participants nor the study doctors know who is receiving study drug and who is receiving placebo
What the Study Entails
- Men with metastatic castration-resistant prostate cancer may be able to take part
- Men will be expected to take six capsules by mouth, once a day, for an average of 85 weeks. They will be randomized into one of two groups and either receive talazoparib (the study drug) and enzalutamide or a placebo and enzalutamide
- Men will be required to make around 25 clinic visits over time for health assessments such as electronic medical questionnaires, physical examinations, blood tests, and CT/MRI and bone scans
- Men will receive a safety follow-up approximately 28 days after their last dose
- Once men have completed their course of treatment, they will continue to be monitored every 12 weeks to assess subsequent treatment(s), disease progression, and survival.
This is a global clinical research study. There are 288 study sites planned in 26 countries worldwide, including:
- United States;
- United Kingdom;
- South Africa.
For more information about the study, visit www.talaprotrials.com/FORCE
Men with metastatic castration-resistant prostate cancer if they are:
- at least 18 years old;
- willing to provide saliva, blood, and tumor tissue samples for genetic testing;
- otherwise in reasonably good health
- DNA damage repair (DDR) deficient (BRCA2, FANCA, CHEK2, BRCA1, PALB2, MRE11A, NBN, RAD51C, ATM, ATR, MLH1, CDK12)
Men who have already received certain types of cancer treatment. These include:
- any systemic cancer treatment (treatment that enters the bloodstream to reach cells all over the body) after castration resistant prostate cancer diagnosis, not including androgen deprivation therapy or first generation anti-androgens;
- enzalutamide, apalutamide or darolutamide;
- platinum-based chemotherapy within 6 months from the last dose.