Study on Talazoparib with Hormone Therapy and Abiraterone for Treating Prostate Cancer Sensitive to Hormone Therapy

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04734730

Provider View

This clinical trial is exploring whether adding the drug talazoparib to standard hormone therapy and abiraterone can improve treatment for men with prostate cancer that still responds to hormone therapy. Talazoparib is a targeted therapy that may help kill cancer cells by preventing them from repairing their DNA.

Patient Parameters

Program Overview

This phase II study is testing the effects of combining talazoparib, a PARP inhibitor, with hormone therapy and abiraterone in men with prostate cancer that is sensitive to hormone treatment. Talazoparib works by blocking an enzyme that helps repair damaged DNA in cancer cells, potentially causing them to die. Hormone therapy reduces the levels of androgens, which are hormones that can promote the growth of prostate cancer cells. By combining these treatments, researchers hope to improve cancer control in patients.

Description

The main goals of this study are to see if adding talazoparib to standard hormone therapy and abiraterone can make the treatment more effective for men with metastatic prostate cancer that is still sensitive to hormone therapy. The study also aims to understand how this combination works in a diverse group of patients and whether certain genetic variations in the androgen receptor can help identify patients who might benefit more from this treatment.

Participants will take talazoparib, abiraterone, and prednisone by mouth daily. They will also receive hormone therapy through injections or pills, depending on the specific treatment plan. The treatment cycles repeat every 28 days as long as the cancer does not progress and the side effects are manageable. After finishing the study treatment, participants will have a follow-up visit 30 days later.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of prostate cancer.
  • Cancer must have spread to other parts of the body.
  • Recent imaging tests must have been done to assess the cancer.
  • May have started hormone therapy for metastatic prostate cancer within the last 60 days.
  • Must have a performance status score indicating they are able to carry out daily activities.
  • Men must agree to use effective contraception during the study and for 4 months after.
  • Must have adequate liver and kidney function based on blood tests.
  • Must have sufficient blood cell counts.
  • Must be able to understand and sign a consent form.
  • May have had previous hormone therapy, but it must not have lasted more than 36 months.
  • May have received prior surgery or radiation therapy, provided they have recovered from side effects.

Exclusion Criteria

  • Must not have received certain other cancer treatments like ketoconazole or enzalutamide.
  • Must not have had chemotherapy for metastatic prostate cancer.
  • Must not have brain metastases.
  • Must not have severe heart conditions or recent heart problems.
  • Must not have uncontrolled high blood pressure.
  • Must not have certain infections or serious medical conditions.
  • Must not have a history of adrenal insufficiency.
  • Must not have allergies to study drugs.
  • Must not be participating in other clinical trials or receiving other cancer treatments.
  • Must not have gastrointestinal issues that affect medication absorption.
  • Must not have had other cancers, except for certain skin cancers or early-stage cancers in remission.

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