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Enroll in Research > Research Search & Enroll Tool > TALAPRO-3: A Clinical Trial in Men with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) and DNA Damage Repair (DDR) Gene Alteration
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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 , an existing, approved treatment for prostate cancer.

NOTE: This study is no longer enrolling patients. 


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 is more effective than 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 , while the other group will receive a and .  
  • 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

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.