Phase 2 Prostate Cancer Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who are 18 years of age or older at the time of signing the consent form
- People who have been diagnosed with localised prostate adenocarcinoma (a specific type of prostate cancer), have not previously taken the drug darolutamide, and are planning to have their prostate surgically removed
- People whose cancer is classified as high risk according to a standard set of medical guidelines (NCCN criteria, version 1.2025)
- People who have no signs of cancer that has spread to distant parts of the body, confirmed by CT scan, MRI, and a full-body bone scan done within 42 days before starting the study treatment
- People who are considered suitable for prostate removal surgery that also includes removal of nearby lymph nodes in the pelvic area
- People whose cancer meets at least one of the following high-risk features: a biopsy score (Gleason score) of 8 or higher, a PSA (prostate-specific antigen) blood test result above 20 ng/mL measured during the screening period, or a tumour that has grown to a stage classified as T3a or higher
- People who have cancer that has spread to nearby pelvic lymph nodes (known as N1 disease) may still be eligible
- People who have a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity)
Who may not be able to join:
- People whose prostate cancer has features known as neuroendocrine differentiation or small cell characteristics
- People who have evidence that the cancer has spread to distant parts of the body (note: cancer spread only to nearby pelvic lymph nodes does not automatically exclude someone)
- People who have previously had a bad reaction to darolutamide or to hormone therapy used to reduce testosterone (androgen deprivation therapy)
- People who have had a loss of consciousness, a mini-stroke (transient ischaemic attack), or a stroke within the 6 months before joining the trial
- People who have had a serious heart or cardiovascular condition within the 6 months before joining the trial
- People who have any medical reason that would make prostate removal surgery unsafe or unsuitable for them
- People with high blood pressure that cannot be controlled with treatment
- People who have had a different type of cancer within the 5 years before joining the trial
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: (+)1-888-84 22937
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
The proportion of participants achieving pathologic response rate (pRR: pathologic complete response [pCR] or minimal residual disease [MRD])
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.