Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer

The goal of this phase 3 clinical trial is to determine the clinical effectiveness and cost effectiveness of using lower doses of Androgen Receptor Pathway Inhibitors (ARPI) to treat patients with prostate cancer that has spread (metastasized). The main questions it aims to answer are: 1. if overall survival for reduced dose ARPI is not worse than standard dose ARPI when treating patients with metastatic prostate cancer, and 2. that fatigue (extreme exhaustion) and not stopping ARPI permanently (due to adverse effects) are better than average with the reduced dose. Participants will: * Be r

Trial Details

NCT ID
NCT07751133
Phase
PHASE3
Sponsor
University College, London
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Abiraterone, Apalutamide, Enzalutamide or Darolutamide (ARPI therapy) (per standard of care) therapy
Locations (sample)
  • Manchester, United Kingdom|53.48095,-2.23743
  • Sutton, United Kingdom|51.35,-0.2

Key Eligibility Criteria

  • Adult males (male sex at birth) aged 18 years or older
  • Newly histologically or cytologically diagnosed prostate cancer (adenocarcinoma) that is metastatic hormone-sensitive (mHSPC) or metastatic castrat…
  • Prior ADT use for prostate cancer (including bilateral orchidectomy and transcutaneous oestrogen), is permitted provided: (a) ADT has been started …
  • ECOG performance status 0-2

For full eligibility, visit ClinicalTrials.gov.

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