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Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer

NCT07751133 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2026-08-07

No results posted yet for this study

Summary

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 randomised to take full dose (100%) of ARPI or half dose (50%) of ARPI.
* Receive standard of care ADT.
* Be on treatment for approximately 3 years according to standard of care.
* Have clinic assessments and visits in clinic or remotely, as per their treating hospital's standard routine local practice in line with standard of care. Additional visits are not expected.
* Complete quality of life questionnaires at week 0 (pre-treatment) and weeks 4, 16, 32, 48 and 64.
* Keep a diary of their symptoms.

Translational research samples will be collected as follows:

* Blood samples at week 0 (pre-treatment) and weeks 24, 32, 48 and at disease progression.
* Urine samples at week 0 (pre-treatment) and week 24 and at disease progression.
* FFPE Tumour: Routinely collected diagnostic blocks. The duration of follow-up is approximately 3 years after the last patient is recruited (minimum follow-up is 3 years; maximum follow-up is approximately 6 years for the the first patient recruited) and the trial is expected to complete August 2032 (Last Patient Last Visit).

Conditions

Interventions

DRUG

Abiraterone, Apalutamide, Enzalutamide or Darolutamide (ARPI therapy) (per standard of care) therapy

ARPI therapy (Abiraterone, Apalutamide, Enzalutamide or Darolutamide) selected by local investigator per standard of care

Sponsors & Collaborators

Principal Investigators

  • Ananya Choudhury, Professor · The Christie NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-03
Primary Completion
2029-08-01
Completion
2033-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07751133 on ClinicalTrials.gov