Study on Adaptive Androgen Deprivation and Docetaxel for Metastatic Castration Sensitive Prostate Cancer

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06734130

Provider View

This clinical trial is exploring whether a combination of hormone therapy and the chemotherapy drug Docetaxel can extend the time during which stage IV prostate cancer remains sensitive to hormone treatment.

Patient Parameters

Program Overview

The purpose of this study is to test if using a combination of hormone therapy (called androgen deprivation therapy or ADT) and the chemotherapy drug Docetaxel can help prolong the period during which stage IV prostate cancer responds to hormone treatment. This is a phase IIa study, meaning it is in the early stages of testing this treatment approach in patients.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of prostate cancer through a biopsy.
  • Have not received hormone therapy (ADT) for more than 4 weeks after being diagnosed with metastatic prostate cancer. Previous hormone therapy is allowed if it was given more than 2 years before the diagnosis of metastatic cancer.
  • Have shown a significant drop in PSA levels (more than 50%) and a PSA level below 4 ng/ml after the initial treatment period.
  • Have good organ function, including specific blood cell counts and normal kidney and liver function.
  • Have no uncontrolled heart rhythm problems and, if there is a history of heart issues, have a heart function test showing adequate heart pumping ability.
  • Be in good overall health, with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Men who are not sterilized and are sexually active with a female partner of childbearing potential must agree to use effective birth control during the study and for 6 weeks after the last dose of treatment.
  • Be able to understand and sign a consent form or have a representative do so, and be willing to follow all study procedures and attend appointments.

Exclusion Criteria

  • Have previously been treated with specific medications like TAK-700, abiraterone, apalutamide, or enzalutamide.
  • Have had surgical removal of the testicles.
  • Have cancer that has spread to the liver or brain.
  • Have a history of allergic reactions to similar drugs as Docetaxel or LHRH analogs.
  • Have taken any experimental drugs within 30 days before starting the study treatment.
  • Have been diagnosed or treated for another cancer within 2 years before starting the study, unless it was early-stage skin cancer or carcinoma in situ that was completely removed.
  • Have uncontrolled health issues, such as active infections, heart failure, unstable chest pain, irregular heartbeats, or mental health conditions that would interfere with the study.
  • Have wounds, ulcers, or bone fractures that are not healing properly.

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