OncoMatch/Clinical Trials/NCT07751133
Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer
Is NCT07751133 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies Abiraterone, Apalutamide, Enzalutamide or Darolutamide (ARPI therapy) (per standard of care) therapy for prostate cancer.
Treatment: Abiraterone, Apalutamide, Enzalutamide or Darolutamide (ARPI therapy) (per standard of care) therapy — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: triplet therapy (systemic anti-cancer therapy such as chemotherapy, radionuclide/molecular radiotherapy, PARPi alongside ADT & ARPI)
Exception: concomitant radiotherapy is allowed
Patients on triplet therapy (i.e. receiving additional systemic anti-cancer therapy such as chemotherapy, radionuclide/molecular radiotherapy, PARPi alongside ADT & ARPI); but concomitant radiotherapy is allowed
Lab requirements
Liver function
Patients with severe hepatic impairment (Child-Pugh Class C) [excluded]
Cardiac function
Patients with uncontrolled or unstable cardiovascular disease, New York Heart Association congestive cardiac failure class III/IV [excluded]
Patients with severe hepatic impairment (Child-Pugh Class C); Patients with uncontrolled or unstable cardiovascular disease, New York Heart Association congestive cardiac failure class III/IV
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07751133 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior triplet therapy (systemic anti-cancer therapy such as chemotherapy, radionuclide/molecular radiotherapy, PARPi alongside ADT & ARPI) disqualifies patients from enrollment.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages