Study on Tulmimetostat and Darolutamide or Abiraterone for Treating Metastatic Hormone-Sensitive Prostate Cancer

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60

ClinicalTrials ID:NCT07190300

Provider View

This clinical trial is testing two different treatment combinations involving the drug tulmimetostat for men with metastatic hormone-sensitive prostate cancer (mHSPC). The study aims to evaluate the safety and effectiveness of these combinations.

Patient Parameters

Program Overview

The purpose of this study is to test the safety and effectiveness of two different treatment combinations using tulmimetostat in men with metastatic hormone-sensitive prostate cancer (mHSPC). The study includes two phases: Phase I will test tulmimetostat with darolutamide and tulmimetostat with abiraterone to find the best dose. Phase II will further evaluate the recommended dose of tulmimetostat with darolutamide to see how well it works. Participants will continue hormone therapy to keep testosterone levels low. The study includes a screening period, treatment period, and long-term follow-up.

Description

The study is divided into two parts:

  1. Phase I: This part has two groups. Group A will receive tulmimetostat with darolutamide, and Group B will receive tulmimetostat with abiraterone. The main goal is to find the best dose for each combination. Participants will continue hormone therapy to keep testosterone levels low. In Group B, abiraterone will be given with a steroid (prednisone or prednisolone).

  2. Phase II: This part will further test the recommended dose of tulmimetostat with darolutamide to see how effective it is. Participants will be randomly assigned to receive either tulmimetostat with darolutamide or darolutamide alone. This phase aims to provide more evidence on the safety and effectiveness of tulmimetostat-based treatments for men with mHSPC.

The study involves a screening period, a treatment period, and a long-term follow-up after treatment.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older with metastatic hormone-sensitive prostate cancer (mHSPC) that has spread to bones or soft tissues.
  • Must have low testosterone levels (≤ 50 ng/dL).
  • Good overall health with an ECOG performance status of 0 to 2.
  • Adequate bone marrow and organ function.
  • Must have started hormone therapy (ADT) at least 1 month but no more than 24 months before joining the study and be willing to continue it.
  • May have received one prior taxane-based therapy for mHSPC but not progressed on it.
  • Prior use of certain hormone therapies (ARPI) is allowed under specific conditions.
  • Previous local treatments like radiation or surgery for prostate cancer are allowed if completed before joining the study.

Exclusion Criteria

  • Participants with castration-resistant prostate cancer (mCRPC) or only PSA recurrence without known metastatic disease.
  • PSA levels of ≤ 0.2 ng/mL at the start of treatment.
  • History of brain metastases unless treated and stable without steroids.
  • Use of certain anti-androgen drugs or herbal products that affect PSA levels.
  • Previous exposure to specific cancer treatments like radioligand therapy or certain investigational drugs.
  • Use of prohibited medications or herbal products that cannot be stopped before the study.

Locations

FACILITYZIPCITYSTATE
Wichita Urology Group PA67226WichitaKansas

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