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:

• You are male and at least 40 years old.
• After surgery, your prostate tissue was confirmed to be a type of prostate cancer called adenocarcinoma.
• After surgery, your lymph node results showed either no cancer in the lymph nodes, or lymph nodes were not tested.
• Your PSA level dropped below 0.1 ng/ml within 8 weeks after surgery and stayed that way for at least 6 months.
• Your PSA level has since risen twice in a row (at least 2 weeks apart) and is above 0.2 ng/ml, but standard scans (bone scan and CT/MRI) have not shown any sign that the cancer has come back locally or spread elsewhere.
• You have at least one of the following higher-risk features: a CAPRA-S score of 6 or more after surgery (confirm with trial site); a Gleason score of 8–10 on your surgical pathology report; your PSA rose above 0.5 ng/ml after surgery; your cancer was found to have grown beyond the prostate (stage pT3 or pT4) after surgery; or your PSA doubling time is less than 10 months (confirm with trial site).
• Your general health and ability to carry out daily activities is good (rated 0 or 1 on a standard activity scale).
• Your life expectancy is greater than 10 years.
• Your blood test results within the 4 weeks before starting the study show that your blood counts, kidney function, liver function, and heart function are all within acceptable ranges.
• You are willing and able to sign a consent form and follow the study requirements.

Who may not be able to join:

• You have previously received any hormone therapy for prostate cancer or radiation therapy to the pelvis.
• Your PSA level after surgery has risen above 2 ng/ml.
• Your surgical pathology report showed cancer types other than adenocarcinoma, such as neuroendocrine or small cell features.
• You are currently taking part in, or have previously taken part in, a clinical trial involving an experimental drug.
• You have a known or suspected allergy to the study drug (reverumide) or any of its ingredients.
• You have difficulty swallowing, chronic diarrhea, a bowel obstruction, or any other condition that could affect how your body absorbs medication.
• You have a history of epilepsy (seizures), or have had a mini-stroke, stroke, or a serious head injury requiring hospitalisation in the 12 months before starting the trial.
• You have had a significant heart problem in the 6 months before starting the trial, such as a heart attack, severe chest pain, heart failure, or serious heart rhythm problems.
• You have been diagnosed with any other cancer in the past 3 years (with some exceptions for very slow-growing or fully resolved cancers — confirm with trial site).
• You received a medication to boost white blood cell counts within 2 weeks before starting the trial.
• You received a blood transfusion within 2 weeks before starting the trial.
• You have an active hepatitis B or hepatitis C infection above certain levels.
• You have a history of a weakened immune system, HIV, any other immune deficiency condition, or have had an organ transplant.
• You and your partner are able to have children, and you are unwilling to use effective contraception during the trial and for 3 months after your last dose of the study drug.
• The study doctor decides that joining the trial may not be safe or suitable for you for any other reason.

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