Phase 3 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 laboratory test on a tissue or cell sample
• People who still have their prostate intact, with no prior treatments aimed at the prostate cancer itself (though previous procedures done for non-cancer reasons, such as relieving urinary blockage, are acceptable)
• People who have cancer that has spread to other parts of the body, confirmed by a bone scan and CT or MRI scan within the past 42 days before starting standard treatment
• People whose cancer has spread to more than one site, or, if only one site is found or it was only detected by certain advanced scans (such as PET scans), the spread must be confirmed by a tissue or cell sample
• People who have received no more than 28 weeks of standard systemic therapy (the currently recommended treatment for metastatic prostate cancer) before registering for the trial
• People whose cancer has not gotten worse while on standard treatment
• People who have had treatment directed at a small number of spread sites (up to four) before being assigned to a study group
• People who have had a full physical exam and medical history review within 28 days before joining the trial
• People who have had their PSA (a prostate-related protein measured in the blood) tested before starting standard treatment and again within 28 days before joining
• People who have had their testosterone level tested within 28 days before being assigned to a study group
• People who have no other current cancers, with limited exceptions: adequately treated skin cancers, certain early-stage cancers that are in full remission, or any other cancer from which the person has been cancer-free for at least three years
• People who are willing to provide biological samples for research purposes
• People who speak English, Spanish, or French and are willing to complete quality-of-life questionnaires
• People who have been informed about the research nature of the trial and have signed a written consent form
• People whose cancer has not progressed (based on PSA levels, scans, or worsening symptoms) during the 28 weeks of standard treatment, confirmed within 28 days before being assigned to a study group
• People who have been assessed by a urologist and whose cancer is considered surgically removable, regardless of whether surgery is planned
• People who have received between 22 and 28 weeks of standard systemic therapy, measured from the date of their first hormonal treatment or surgical procedure to lower testosterone
• People whose side effects from standard treatment have largely resolved (to a mild level or better) before being assigned to a study group
• People who have a testosterone level below 50 ng/dL within 28 days before being assigned to a study group
• People who are in good general health and able to carry out daily activities with little or no limitation (confirmed within 28 days before being assigned to a study group)

Who may not be able to join:

• People whose prostate cancer is a type other than adenocarcinoma, such as pure small cell carcinoma, sarcomatoid, or squamous cell carcinoma
• People who have already had a treatment directed at the prostate cancer itself, such as radiation seeds (brachytherapy), high-intensity focused ultrasound, cryotherapy, or laser ablation of the cancer
• People whose cancer spread is only visible on certain advanced PET scans and not on standard bone scans, CT, or MRI — unless the spread has been confirmed by a tissue or cell sample
• People who have cancer that has spread to the brain, or whose brain imaging (if performed) shows signs of cancer
• People whose cancer got worse while on standard treatment
• People who plan to receive a chemotherapy drug called docetaxel after being assigned to a study group
• People with a current cancer diagnosis other than the exceptions listed above (certain skin cancers, early-stage cancers in full remission, or cancers from which the person has been cancer-free for three or more years)

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