TALAPRO-3: A Clinical Trial in Men with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) and DNA Damage Repair (DDR) Gene Alteration
https://www.facingourrisk.org/research-clinical-trials/study/153/talapro-3-a-clinical-trial-in-men-with-metastatic-castration-sensitive-prostate-cancer-mcspc-and-dna-damage-repair-ddr-gene-alteration
Clinicaltrials.gov identifier:
NCT04821622 (https://clinicaltrials.gov/show/NCT04821622)
Treatment
Metastatic castration-sensitive prostate cancer
Study Contact Information:
For more information about the study, visit www.Talapro3ClinicalTrial.com
About the Study
TALAPRO-3 is a trial for men who have been diagnosed with metastatic castration-sensitive prostate cancer (mCSPC) which means that the tumor has spread to other parts of the body but is still sensitive to hormone therapies.
This clinical trial is investigating if a study drug called talazoparib, is effective and safe when given alongside enzalutamide, an existing, approved treatment for metastatic prostate cancer.
NOTE: This study is no longer enrolling patients.
Type of Trial
People with metastatic castration-sensitive prostate cancer may be able to take part. This is a Phase 3, randomized, double blind, placebo-controlled study. The goal is to assess if talazoparib (the study drug) plus enzalutamide is more effective than enzalutamide alone in helping to delay the spread of cancer and is safe.
- 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.
Taking part in the Talapro-3 study will include:
- Taking approximately six capsules by mouth, once a day, for an average of 3 years
- Making around 25 clinic visits for health assessments such as electronic medical questionnaires, physical examinations, blood tests, and CT/MRI and bone scans
- Receiving a safety follow-up approximately 28 days after the last dose
- Continuing to be monitored every 8 or 12 weeks following completion of initial treatment, to assess subsequent treatment(s), disease progression, and survival
Study Sites
This is a global clinical research study. There are 285 study sites planned in 29 countries worldwide, including:
- United States
- Argentina
- Australia
- Belgium
- Bulgaria
- Canada
- China
- Czech Republic
- Finland
- France
- Germany
- Hungary
- India
- Italy
- Japan
- Republic of Korea
- Mexico
- Netherlands
- Norway
- Russian Federation
- Slovakia
- South Africa
- Spain
- Sweden
- Taiwan
- Turkey
- Ukraine
- United Kingdom
For more information about the study, visit www.Talapro3ClinicalTrial.com
This Study is Open To:
NOTE: This study is no longer enrolling patients.
This Study is Not Open To:
NOTE: This study is no longer enrolling patients.
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.