Half the dose, same hope? trial tests cutting hormone therapy in prostate cancer
NCT ID NCT07751133
First seen Aug 07, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This phase 3 trial is testing whether giving men with metastatic prostate cancer half the standard dose of certain hormone therapies (called ARPIs) can be just as effective as the full dose, while causing less fatigue and fewer treatment stoppages. About 1,500 men with prostate cancer that has spread will be randomly assigned to receive either the full or half dose, alongside standard hormone therapy. The study will compare overall survival, fatigue levels, and how many men can stay on treatment without stopping due to side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Androgen Receptor Pathway Inhibitors (ARPI) at half the standard dose, combined with standard androgen deprivation therapy (ADT)
- What this could lead to
- If successful, this could show that a lower dose of hormone therapy is just as effective but with less fatigue, improving quality of life for men with metastatic prostate cancer.
- What could go wrong
- The trial is large and phase 3, but the lower dose might not be as effective in controlling the cancer, and the results may not apply to all patients. Side effects could still occur even at half dose.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Aug 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Christie NHS Foundation Trust
RECRUITINGManchester, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?