Phase 2 Prostate Cancer Trial, Recruiting

Written by an AI model from the 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 are male and aged 18 or older.
• People who are willing to sign a consent form before joining the trial, as required by local regulations.
• People whose imaging scans (including MRI, bone scan, and a special PET/CT scan called PSMA PET/CT) have confirmed locally advanced or limited-spread prostate cancer with no more than 5 bone spots involved and no spread to internal organs, and who doctors have assessed as able to tolerate surgery (prostate removal and lymph node removal) after an initial treatment phase.
• People whose prostate cancer has been confirmed by a tissue sample (biopsy) as a specific type called adenocarcinoma, without certain rare aggressive features (small cell or neuroendocrine).
• People who are in generally good physical condition (rated 0 or 1 on a standard health scale) and have a life expectancy of at least 3 years.
• People whose blood and organ function tests — including blood counts, liver function, kidney function, and protein levels — meet the minimum levels required, tested within 4 weeks before joining.
• People who are willing to have genetic testing done before enrolling.
• People who have not had any prior treatment for prostate cancer, although up to 28 days of certain hormone-related medications (LHRHa, non-steroidal anti-androgen, or rezvilutamide) is allowable beforehand.
• People who are able to swallow oral (tablet or capsule) medication and follow study procedures.
• People who are willing to use reliable contraception such as condoms and not donate sperm throughout the study and for 3 months after the last treatment dose.
• People who have no known reasons they cannot safely take any of the medications used in this trial.

Who may not be able to join:

• People who have had an allergic reaction to any of the drugs involved in this trial.
• People who received more than 28 days of certain hormone therapies (LHRHa, non-steroidal anti-androgen, or rezvilutamide) before registering, participated in another treatment-focused clinical trial within 28 days before enrolling, or received any approved cancer treatment within 28 days before enrolling.
• People who have already had local treatment to their prostate cancer or any spread sites before enrolling.
• People who have had both testicles surgically removed (bilateral orchiectomy) before enrolling.
• People with very low testosterone levels (more than 50 ng/dL below the institution's normal range) due to a hormone condition.
• People with a history of cancer that has spread to the brain, or a history of epilepsy (seizures).
• People with serious heart or blood vessel conditions, including: a heart attack or blood clot in the past 6 months; unstable chest pain (angina); a documented history of significant heart failure; a prolonged electrical signal in the heart on ECG (QT interval above 480 ms); or blood pressure that cannot be controlled (resting readings above 170/105 mmHg).
• People with significant digestive system problems that could affect how the study medications are absorbed, such as being unable to swallow, chronic diarrhoea, bowel blockage, or having had the entire stomach removed.
• People with other serious ongoing health conditions judged by the trial doctor to make participation unsafe, including uncontrolled lung disease, active brain or nervous system disease, or active infections requiring treatment.
• People with another active cancer currently requiring treatment, or who have had another cancer in the past 5 years.
• People who had surgery (other than a diagnostic prostate biopsy) within 4 weeks before enrolling.
• People with active or known HIV with a detectable viral load; active hepatitis B (confirmed by viral testing); or hepatitis C, unless it has been treated and the viral load is undetectable.
• People with a history of not following medical treatment plans, or who for any other reason are considered by the trial team to be unsuitable for participation.

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