Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Mężczyźni w wieku 18 lat i starsi
- •Nowo wykryty rak prostaty, który rozprzestrzenił się na inne części ciała
- •Pacjent kwalifikuje się do leczenia lekami hamującymi receptory androgenowe w połączeniu z terapią hormonalną
- •Poprzednie leczenie hormonalne jest dozwolone, jeśli zostało rozpoczęte mniej niż 12 tygodni przed włączeniem do badania
- •Ogólny stan zdrowia pozwalający na podjęcie leczenia (ECOG 0-2)
- •Gotowość do podpisania świadomej zgody na udział w badaniu
✗ Disqualifies
- •Inne rodzaje raka prostaty niż gruczolakorak
- •Brak możliwości lub chęci przyjmowania terapii hormonalnej równocześnie z lekami hamującymi receptory androgenowe
- •Inny nowotwór wymagający aktywnego leczenia w ciągu ostatnich 2 lat przed włączeniem do badania
- •Problemy psychiczne, rodzinne lub społeczne uniemożliwiające uczestnictwo w badaniu
- •Uczestnictwo w innym badaniu klinicznym w ciągu ostatnich 30 dni
- •Otrzymywanie chemioterapii lub innych leków przeciwnowotworowych jednocześnie z terapią hormonalną i lekami hamującymi receptory androgenowe
- •Uczulenie na składniki leku badanego
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 4, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (1)
The Christie NHS Foundation Trust
Manchester, United Kingdom
Trial contact
ENHANCE Trial Manager
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/5/2026.
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