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 a type of prostate cancer called adenocarcinoma (including intraductal adenocarcinoma), confirmed by a biopsy — small cell carcinoma is not included
• People whose cancer is classified as stage T1, T2, or T3 based on a physical examination and prostate MRI scan
• People with higher-risk features (such as stage T3 disease, a Gleason score of 8–10, or a PSA level above 15) who have had imaging tests showing no signs that the cancer has spread
• People with no evidence that the cancer has spread to lymph nodes or other parts of the body, based on physical examination or imaging
• People with a Gleason score between 6 and 10 (a measure of how the cancer cells look under a microscope)
• People with a PSA blood test result of 100 ng/mL or lower, taken within the past 3 months (if PSA was above 100 but dropped to 100 or below after a course of antibiotics, this may still be acceptable)
• People who have a suspicious area identified on a specialised prostate MRI scan (called a multiparametric MRI), in either the outer or inner zone of the prostate, meeting specific imaging criteria
• People who have not previously had radiation treatment to the pelvic area
• People who have not previously had the prostate fully removed by surgery (a prior suprapubic prostatectomy, which is a different type of procedure, is acceptable)
• People who do not currently have another active cancer, except for certain non-spreading skin cancers or early-stage chronic lymphocytic leukaemia — or whose prior cancer has been in remission for 5 or more years
• People who are able to understand the trial and are willing to sign a consent form
• People with a general health and activity level rated as reasonably functional (Zubrod performance status of 2 or lower, which means the person may have some symptoms but is still able to care for themselves)
• People aged between 35 and 85 years at the time of signing the consent form
• People whose testosterone level is within an acceptable range (within 40% of the normal limits set by the lab), tested within the past 3 months
• People who are unable to receive iodine or gadolinium contrast dyes (used in some imaging scans) due to allergy or reduced kidney function — this does not prevent joining the trial

Who may not be able to join:

• People who have previously had radiation treatment to the pelvic area
• People who have previously received hormone therapy to reduce androgen (male hormone) levels
• People who have previously had or are planning to have surgery to fully remove the prostate
• People whose imaging shows evidence that the cancer has spread to lymph nodes or distant parts of the body — note that people with small suspicious lymph nodes (under 1.5 cm) on certain PET scans may still be eligible for one part of the trial (HypoLEAD) but not another (FTLEAD), and the treating doctor can discuss this further
• People who currently have another active cancer, other than certain non-spreading skin cancers or early-stage chronic lymphocytic leukaemia — unless a prior cancer has been in remission for more than 5 years
• People whose general health and activity level is rated as too limited (Zubrod status above 2)
• People with a PSA level above 100 ng/mL before treatment starts, or a Gleason score below 6 — unless PSA dropped to 100 or below after antibiotics
• People whose cancer has been classified as stage T4 (meaning it has grown into nearby structures beyond the prostate)
• People who are not able to make their own informed decisions and cannot voluntarily sign a consent form
• People who are unable to tolerate having an MRI scan — note that being unable to tolerate contrast dyes used in MRI does not prevent joining the trial

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