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
Treatment
Metastatic castration-sensitive prostate cancer
Study Contact Information:
For more information about the study, visit www.Talapro3ClinicalTrial.com
TALAPRO-3: A Clinical Trial in Men with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) and DNA Damage Repair (DDR) Gene Alteration
About the Study
TALAPRO-3 is a trial for men who have been diagnosed with castration-sensitive 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 , is effective and safe when given alongside enzalutamide, an existing, approved treatment for prostate cancer.
For more information about the study, visit www.Talapro3ClinicalTrial.com
Type of Trial
People with castration-sensitive cancer may be able to take part. This is a Phase 3, , double blind, study. The goal is to assess if (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 . Placebos are inactive ingredients; it is normal in clinical research like this to measure results against a in order to be sure that the study drug is responsible for any effects seen.
- Participants will be into two different treatment groups. One will be given (the study drug) and enzalutamide, while the other group will receive a 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 .
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
Men with castration-sensitive cancer if they:
- are at least 18 years old
- are willing to provide saliva, blood, and tumor tissue samples for genetic testing
- are otherwise in reasonably good health
- have a damage repair (DDR) gene alteration, such as: , FANCA, , , , MRE11A, , , , ATR, or CDK12
Men who have already received certain types of cancer treatment. These include:
- prior ADT in the adjuvant/neoadjuvant setting, where the completion of ADT was less than 12 months prior to randomization and the total duration of ADT exceeded 36 months
- prior treatment with a
- prior treatment with platinum-based chemotherapy within 5 years prior to randomization, except for indications other than cancer
- treatment with systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to randomization, intended for treatment of cancer
- current use of potent P-gp inhibitors within 7 days prior to randomization