RecruitingPhase 2NCT06582628

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

A Multicenter, Open Label, Randomized Phase II Trial to Evaluate the Efficacy of Talazoparib Plus Enzalutamide as First Line Treatment for Patients With Metastatic Castration Resistant Prostate Cancer Following Progression on Abiraterone


Sponsor

Fundacion Oncosur

Enrollment

78 participants

Start Date

Jul 5, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the combination of two drugs — talazoparib (a PARP inhibitor that blocks cancer cell DNA repair) and enzalutamide (a hormone-blocking therapy) — in men with metastatic prostate cancer whose cancer has grown despite prior treatment with abiraterone, another hormone therapy. **You may be eligible if...** - You are male, aged 18 or older - You have been diagnosed with metastatic prostate cancer (cancer that has spread beyond the prostate) - Your cancer progressed while on abiraterone therapy - You have not previously received enzalutamide, apalutamide, or darolutamide **You may NOT be eligible if...** - Your cancer has spread to the brain - You have had prior treatment with PARP inhibitors - You have significant bone marrow suppression or low blood counts Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEnzalutamide capsule

Enzalutamide capsules 160 mg orally daily

DRUGEnzalutamide capsule and Talazoparib capsule

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


Locations(12)

Institut Català d'Oncologia (ICO)

Badalona, Barcelona, Spain

Consorcio Corporación Sanitaria Parc Taulí

Sabadell, Barcelona, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario de Jerez de la Frontera

Cadiz, Cádiz, Spain

Hospital Universitario Cruces

Barakaldo, Vizcaya, Spain

Hospital Universitario Del Mar.

Barcelona, Spain

Hospital Clínico y Provincial de Barcelona

Barcelona, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

View Full Details on ClinicalTrials.gov

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NCT06582628


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