RecruitingPhase 2NCT05873192

Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer

Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in de Novo Metastatic to Lymph Nodes Prostate Cancer


Sponsor

M.D. Anderson Cancer Center

Enrollment

30 participants

Start Date

Jun 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To learn about the effectiveness of adding talazoparib to the standard of care treatment combination of androgen ablation therapy (hormone therapy, also known as ADT) and enzalutamide in patients with prostate cancer that has spread into the lymph nodes.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — talazoparib (a PARP inhibitor that disrupts cancer cell DNA repair) and enzalutamide (a hormone-blocking drug) — given before surgery in men with high-risk prostate cancer, to shrink the tumour and potentially improve surgical outcomes. **You may be eligible if...** - You have prostate adenocarcinoma that a urologist believes could be surgically removed after a response to treatment - You are planning to have a radical prostatectomy (surgical removal of the prostate) at the end of the study period - Your overall health is adequate (ECOG 2 or better) - You meet specific staging criteria (e.g., confirmed lymph node involvement, or other high-risk features) **You may NOT be eligible if...** - Your cancer has spread to distant organs beyond the lymph nodes - You have certain heart conditions or liver problems - You have previously received hormone therapy or chemotherapy for prostate cancer 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

DRUGADT

Given by PO

DRUGEnzalutamide

Given by PO

DRUGTalazoparib

Given by PO

DRUGDegarelix

Given PO or given INJ

DRUGLuprolide

Given PO or given INJ


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT05873192


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