Study on Talazoparib and Enzalutamide Before Surgery for Prostate Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT05873192

Provider View

This clinical trial is exploring whether adding the drug talazoparib to standard hormone therapy and enzalutamide can improve treatment outcomes for prostate cancer that has spread to the lymph nodes. The study aims to see if this combination can help control the cancer before surgery.

Patient Parameters

Program Overview

The purpose of this study is to find out if using talazoparib along with hormone therapy and enzalutamide before surgery can effectively treat prostate cancer that has spread to the lymph nodes. Researchers want to see if this combination can lower prostate-specific antigen (PSA) levels one year after surgery and improve long-term outcomes like disease-free survival. The study will also evaluate the safety of this treatment approach and explore how it affects cancer cells at a genetic level.

Description

This study is testing a new treatment approach for prostate cancer that has spread to the lymph nodes. The main goal is to see if adding talazoparib to hormone therapy and enzalutamide before surgery can help control the cancer. Researchers will measure the success of the treatment by checking if PSA levels become undetectable one year after surgery. They will also look at how the cancer responds to the treatment and how long patients remain free of cancer after the treatment.

The study will also assess the safety of the treatment and explore how it affects cancer cells at a genetic level. Researchers will collect tissue samples to study potential biomarkers that could predict how well the treatment works or why it might not work for some patients. This information could help improve future treatments for prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Have prostate cancer that can be surgically removed after treatment.
  • Be considered a good candidate for surgery and agree to have surgery after the treatment.
  • Have a performance status score of 2 or better, meaning you are able to carry out daily activities with some limitations.
  • Have cancer that has spread to the lymph nodes, confirmed by biopsy or imaging tests.
  • Have not received more than 6 weeks of prior hormone therapy.
  • Agree to provide tissue samples for research purposes.
  • Have adequate blood cell counts and organ function based on specific medical tests.
  • Discontinue medications that lower the seizure threshold at least 4 weeks before starting the study.
  • Agree to use effective contraception during the study and for at least 4 months after treatment.
  • Sign an informed consent form and agree to follow the study procedures.
  • Have a consultation with a surgeon and oncologist before joining the study.

Exclusion Criteria

  • Have a type of prostate cancer called small cell or sarcomatoid.
  • Have cancer that has spread to the bones or other areas outside the lymph nodes.
  • Have received chemotherapy or more than 4 weeks of hormone therapy for prostate cancer.
  • Have gastrointestinal issues that prevent taking oral medication or affect absorption.
  • Have a history of certain blood disorders or other cancers with a high chance of returning.
  • Have allergies to the study drugs or their ingredients.
  • Have heart conditions or uncontrolled high blood pressure.
  • Have active infections or liver disease.
  • Have a history of seizures or conditions that increase seizure risk.
  • Have mental health issues that affect the ability to consent or follow the study.
  • Plan to participate in another drug study.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.