Lower-dose ARPI therapy for metastatic prostate cancer
Official title: Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer
Run by University College, London · NCT07751133 · Data updated 2026-11-12
This trial tests whether using half the usual dose of ARPI therapy can work as well as a full dose for men with metastatic prostate cancer who are also receiving standard hormone therapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 1500 (estimated) |
| Sponsor | University College, London Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Huddersfield and 3 other locations) |
| Status | Recruiting |
| Started | August 28, 2026 |
| Main results expected | August 1, 2029 |
| Study ends | August 1, 2033 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07751133 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men aged 18 or older with newly diagnosed metastatic hormone-sensitive or metastatic castration-resistant prostate cancer planned to receive ARPI plus ADT.
✕Probably not a fit
Patients whose disease does not respond to ARPI or who cannot tolerate lower-dose therapy may not experience the same benefits.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this Phase 3 trial, adult men with metastatic hormone-sensitive or castration-resistant prostate cancer will be randomized to receive either the standard 100% dose or a reduced 50% dose of an ARPI (abiraterone, apalutamide, enzalutamide, or darolutamide) plus standard androgen deprivation therapy. Participants will be followed for about three years with clinic visits, questionnaires, and symptom diaries to assess overall survival, quality of life, and treatment-related fatigue. Biological samples will be collected for translational research and analyzed at a central Manchester lab. The study aims to determine if a lower ARPI dose is not worse than the standard dose in survival and whether it reduces fatigue and treatment discontinuation due to adverse effects.
Why it matters
Potential benefit: If successful, patients may achieve similar survival with fewer side effects and better quality of life due to lower ARPI exposure.
How similar studies have gone: Previous studies have explored dose optimization in cancer therapy, but this trial addresses a specific ARPI dosing strategy in metastatic prostate cancer and is somewhat novel in its direct comparison of 100% vs 50% dosing.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult males (male sex at birth) aged 18 years or older 2. 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 3. 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 4. ECOG performance status 0-2 5. Willing and able to give provide written informed consent. Exclusion Criteria: 1. Pathology other than adenocarcinoma consistent with small cell, ductal, sarcomatoid carcinoma of the prostate 2. Unable or unwilling to receive concurrent ADT alongside an ARPI 3. Any concurrent or previous malignancy that required active anti-cancer therapy in the previous 2 years of randomisation (other than basal cell or squamous cell carcinoma of the skin or adequately treated non-muscle invasive urothelial bladder carcinoma, Tis, Ta and T1 tumours) 4. Adults with unmanaged psychological, familial, or sociological conditions precluding them from the ability to provide informed consent or hampering compliance with the study follow-up, including continued drug and alcohol dependence 5. Patients who have received an investigational drug (either approved or not approved) in any prior clinical study within 30 days or 5 half-lives (whichever is longer) prior to Screening 6. 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 7. Hypersensitivity to any of the active components or excipients of the IMPs or NIMPs listed in this protocol 8. Patients with severe hepatic impairment (Child-Pugh Class C) 9. Patients with uncontrolled or unstable cardiovascular disease, New York Heart Association congestive cardiac failure class III/IV
Where it's running
-
Calderdale and Huddersfield NHS Foundation Trust
Huddersfield, United Kingdom Recruiting -
University Hospitals of Leicester NHS Trust
Huddersfield, United Kingdom Recruiting -
The Christie NHS Foundation Trust
Manchester, United Kingdom Recruiting -
The Royal Marsden NHS Foundation Trust
Sutton, United Kingdom Recruiting
Study contacts
- Principal investigator: Ananya Choudhury, Professor — The Christie NHS Foundation Trust
- Study coordinator: ENHANCE Trial Manager
- Email: ctc.enhance@ucl.ac.uk
- Phone: +44 (0) 207 679 9898
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.