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 been diagnosed with prostate adenocarcinoma (a specific type of prostate cancer), confirmed by a tissue sample
• People who are 18 years of age or older
• People who are generally able to carry out daily activities with no or minimal limitations (as assessed by their doctor using a standard performance scale)
• People whose PSA (a prostate cancer marker in the blood) has been rising while on a drug called darolutamide — specifically, three rising PSA measurements taken at least one week apart, while testosterone levels remain at castrate level (very low)
• People whose cancer has not spread to distant parts of the body according to standard scans (CT or bone scan), even if an earlier specialist PET scan showed some spread, provided standard scans now show no distant spread after at least 18 months of hormone therapy plus darolutamide
• People who have small lymph nodes (up to 2cm) in the pelvis area on imaging
• People with a PSA level above 1.0 ng/mL at the time of screening
• People with very low testosterone levels (below 1.7 nmol/L) who are receiving ongoing hormone-suppressing injections or implants
• People with adequate bone marrow, liver, and kidney function, as confirmed by blood tests meeting specific thresholds
• People who are willing and able to follow all study requirements, including treatment schedules

Who may not be able to join:

• People with a life expectancy of less than 3 months
• People who have had a type of prostate cancer called neuroendocrine or small cell prostate cancer identified in any past tissue sample
• People whose cancer has been shown to have spread to distant parts of the body on standard scans (CT or bone scan) at any point during their illness, except for small pelvic lymph nodes under 2cm
• People who have previously been treated with enzalutamide, abiraterone, or apalutamide, or who have had chemotherapy — although people with small pelvic lymph node involvement at original diagnosis who completed docetaxel chemotherapy at least 12 months before starting the trial may still be considered eligible (confirm with trial site)
• People with certain heart or blood clot-related conditions, including: a heart attack or unstable chest pain within the past 24 months; uncontrolled or symptomatic heart disease (such as breathlessness, chest pain, or irregular heartbeat); significant uncontrolled high blood pressure despite treatment; or heart failure rated at a moderate-to-severe level by a doctor
• People diagnosed with another cancer within the past 2 years — although people with a history of certain skin cancers, carcinoma in situ, or early bladder cancer treated with curative intent, or people who have been continuously free of any other cancer for at least 2 years, may still be considered eligible (confirm with trial site)
• People with another ongoing illness that their doctor believes would make participation unsafe or impractical
• People taking other medications that interact with the trial treatment in a way that cannot be managed before joining the trial (confirm with trial site)
• People who have had radiation therapy within the 4 weeks before joining — although people who received a specific type of targeted radiotherapy (SBRT) to areas seen only on a specialist PET scan (not on standard scans) while continuing darolutamide may still be considered eligible (confirm with trial site)

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