Phase 2 Prostate Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have given written consent to participate, as required by Swiss law and international clinical trial regulations
• People who have a confirmed diagnosis of prostate adenocarcinoma (a specific type of prostate cancer), confirmed through a tissue or cell sample
• People whose prostate cancer has continued to grow despite having very low testosterone levels, either through surgical removal of the testicles or through ongoing hormone-blocking medication
• People who have not had surgical removal of the testicles and who agree to continue taking hormone-blocking medication throughout the trial
• People whose cancer has spread to other parts of the body, confirmed by medical imaging using specific accepted guidelines
• People whose cancer can be measured or assessed through imaging, including bone lesions
• People who have been on a combination of hormone therapy and an advanced prostate cancer drug for at least 12 months, and whose PSA levels dropped by at least 50% or whose cancer showed a meaningful response during that time (confirm with trial site)
• People whose cancer has shown signs of progressing before joining the trial, meeting at least 2 of these 3 signs: a significant rise in PSA levels, new areas of cancer seen on imaging, or noticeable worsening of symptoms (confirm with trial site)
• People who have previously had another type of cancer, where that prior cancer is considered very unlikely to affect the safety or results of this trial
• People aged 18 years or older
• People who are reasonably active and able to care for themselves, as assessed by a standard health scale (WHO performance status 0–2)
• People whose blood counts, liver function, and kidney function meet the minimum levels required for safe participation (confirm specific values with trial site)
• People who agree not to donate sperm or father a child during the trial and for at least 3 months after the last dose of trial treatment
• People who are able and willing to swallow the study tablet (darolutamide) whole

Who may not be able to join:

• People whose prostate cancer includes a small cell component (a particular aggressive cancer subtype)
• People who have already received systemic treatment specifically for castration-resistant prostate cancer
• People who have previously had chemotherapy for metastatic hormone-sensitive prostate cancer, with the exception of a drug called docetaxel
• People who have previously been treated with Lu-PSMA therapy or radium-223 for prostate cancer
• People who are currently taking, or have taken within the past 28 days, another experimental drug as part of a different trial
• People who are currently using other cancer treatments or radiotherapy, other than local pain-relief radiation and hormone-blocking medication
• People with severe or poorly controlled heart or blood vessel disease
• People who have had a serious flare-up of a chronic illness, a significant infection, or major surgery within 28 days before the expected start of treatment
• People who have current evidence of spinal cord compression, based on symptoms or imaging
• People who are taking medications that are known to be unsafe to use alongside the study drug darolutamide
• People who have a known allergy or sensitivity to darolutamide
• People with known digestive system conditions or who have had digestive procedures that could affect how the body absorbs or tolerates darolutamide
• People with any other serious medical, mental health, personal, or geographic circumstances that, in the investigator's judgement, could interfere with treatment, assessments, or follow-up, or place the person at high risk from treatment-related complications

Important: Always verify eligibility with the trial site directly before applying.