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Talazoparib Plus Enzalutamide After Progression to Abiraterone in Metastatic Prostate Cancer: (TEAM PC)

NCT06582628 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-12-02

No results posted yet for this study

Summary

The purpose of this clinical trial is to determine the anti-tumor activity of talazoparib plus enzalutamide as first line treatment for metastatic castration resistant prostate cancer (mCRPC) in participants whose disease has progressed on abiraterone.

The main questions it aims to answer are:

* Does talazoparib plus enzalutamide improve efficacy in metastatic castration resistant prostate cancer (mCRPC) compared to enzalutamide alone?
* What is the time to disease progression \[radiographic, Prostate Specific Antigen (PSA), clinical\] in participants treated with talazoparib plus enzalutamide after progression on abiraterone?
* What medical problems do participants have when receiving talazoparib plus enzalutamide?

Researchers will compare the combination of talazoparib and enzalutamide as a first-line treatment for mCRPC to see if the combination improves the PSA response rate and delays progression compared to enzalutamide alone. The safety and tolerability of the combination (talazoparib and enzalutamide) will also be studied

Conditions

Interventions

DRUG

Enzalutamide capsule

Enzalutamide capsules 160 mg orally daily

DRUG

Enzalutamide capsule and Talazoparib capsule

Enzalutamide capsules 160 mg plus talazoparib capsules 0.5 mg, both orally daily

Sponsors & Collaborators

  • Fundacion Oncosur

    lead NETWORK

Principal Investigators

  • Elena Castro, Dra. · Hospital 12 de Octubre

  • Maria Ruiz Vico, Dra. · Hospital 12 de Octubre

  • David Olmos, Dr. · Hospital 12 de Octubre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-05
Primary Completion
2026-01-31
Completion
2027-10-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06582628 on ClinicalTrials.gov