Can a Two-Drug attack stall resistant prostate cancer?
NCT ID NCT07723248
First seen Jul 23, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This phase 3 trial is testing whether adding an experimental drug called rinzimetostat to the standard drug darolutamide can slow the progression of metastatic castration-resistant prostate cancer better than current treatments. The study enrolls men whose cancer has worsened after treatment with abiraterone. Participants will receive either the combination or a standard therapy chosen by their doctor, and researchers will compare how long the cancer stays under control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of rinzimetostat and darolutamide
- What this could lead to
- If successful, this combination could offer a new treatment option for men with metastatic castration-resistant prostate cancer who have already tried abiraterone.
- What could go wrong
- This is an early-phase 3 trial, and the combination may not prove more effective than existing therapies. Side effects from the drug combination are also possible.
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 600 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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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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: * Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features * Progressive disease in the setting of surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required * Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ function Exclusion Criteria: * Prior treatment for prostate cancer at any stage with cytotoxic chemotherapy, radioligand therapy (ie, 177Lu -PSMA-617, radium-223), ARPIs including apalutamide, darolutamide, and enzalutamide, PARP monotherapy or other systemic anticancer treatment (approved drugs or experimental compounds such as, antibody therapy, immunotherapy, gene or cell therapy, angiogenesis inhibitors, CDK4/6 inhibitors, PRC2 inhibitors) with the following exceptions: 1. Treatment with first-generation antiandrogen agents (eg, bicalutamide, flutamide, nilutamide), but must be discontinued prior to the first dose of study medication 2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure or disease progression occurred during treatment or within 3 months of treatment completion * Any other anticancer therapy (drug or vaccine which does not meet exclusion criterion 1 above) within 28 days or 5 half-lives (whichever is longer) prior to randomization * Known or suspected brain metastasis or active leptomeningeal disease * Clinically significant cardiovascular disease defined as: * Any medical (including active or clinically significant bacterial, fungal, or viral infection) or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the patient inappropriate for the study * Active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery are excluded
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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
7 sites. 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. 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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First Urology PSC
RECRUITINGJeffersonville, Indiana, 40207, United States
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Gabrail Cancer Center Research
RECRUITINGCanton, Ohio, 44718, United States
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Houston Metro Urology (HMU)
RECRUITINGHouston, Texas, 77027, United States
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Summit Urology
RECRUITINGMurray, Utah, 84107, United States
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Urology Clinics Of North Texas
RECRUITINGDallas, Texas, 75231, United States
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Urology Partners of North Texas (UPNT)
RECRUITINGFort Worth, Texas, 76132, United States
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Urology Specialists of the Carolinas - University Place
RECRUITINGCharlotte, North Carolina, 29464, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Cancer-Targeting drug slow advanced prostate cancer?
- Can a smart radiation drug hunt down prostate cancer cells?
- Can a new daily pill slow advanced prostate cancer?
- Can a radioactive injection extend life in advanced prostate cancer?
- Chemo combo vs. radioactive drug: which tames aggressive prostate cancer?
- Can a new pill outsmart resistant prostate cancer?