Prostate Cancer Clinical Trials

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Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 castration resistant prostate cancer (mCRPC), for whom ARPI in combination with androgen deprivation is clinically planned

• Prior ADT use for prostate cancer (including bilateral orchidectomy and transcutaneous oestrogen), is permitted provided: (a) ADT has been started less than 12 weeks prior to randomisation in mHSPC, (b) In the adjuvant setting the completion of adjuvant hormonal therapy was \>12 months prior to randomisation and total duration is capped at 36 months total

• ECOG performance status 0-2

• Willing and able to give provide written informed consent.

Locations
Other Locations
United Kingdom
The Christie NHS Foundation Trust
RECRUITING
Manchester
Contact Information
Primary
ENHANCE Trial Manager
ctc.enhance@ucl.ac.uk
+44 (0) 207 679 9898
Time Frame
Start Date: 2026-08-28
Estimated Completion Date: 2033-08-01
Participants
Target number of participants: 1500
Treatments
Active_comparator: Control Arm
Standard Dose = Standard recommended (100%) dose of ARPI (enzalutamide, apalutamide, darolutamide or abiraterone).
Experimental: Interventional Arm
Reduced Dose = Reduced dose (50%) of the standard recommended dose of ARPI (enzalutamide, apalutamide, darolutamide or abiraterone).
Related Therapeutic Areas
Sponsors
Collaborators: Cancer Research UK, Prostate Cancer UK, University of Manchester
Leads: University College, London

This content was sourced from clinicaltrials.gov