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 are male and at least 18 years old
• People who have had their prostate removed (radical prostatectomy) as the main treatment for confirmed prostate cancer
• People whose PSA levels have risen again after surgery (called biochemical recurrence), meeting specific PSA thresholds depending on when the rise was detected — the exact thresholds depend on timing and imaging results (confirm with trial site)
• People who have had a PET scan (a specialised imaging scan) using an approved radiotracer, completed either before or after registering for the trial, within the timeframes specified by the trial
• People with no clear sign of cancer spread outside the pelvis on standard imaging (CT, MRI, or bone scan), done within about 6 months before joining
• People who are considered suitable candidates for radiation therapy to the prostate bed and pelvic lymph nodes, combined with hormone therapy (ADT)
• People who are able to understand and sign a consent form, or who have an authorised representative or family member who can assist with this
• People with a general health and activity level rated 0, 1, or 2 on a standard medical scale (meaning able to carry out daily activities, with or without some limitations)
• People who have not yet started hormone therapy (ADT) for the current recurrence before their baseline PET scan
• People who are able to lie flat and still for approximately 20–30 minutes for a PET scan and radiation planning
• People who meet their hospital's safety requirements for MRI, if a PET/MRI is being used
• People with blood test results within acceptable ranges, taken within 8 weeks before joining, including: haemoglobin, white blood cell counts, platelets, liver function tests, and kidney function (confirm specific values with trial site)
• People living with HIV who are on effective treatment and have had an undetectable viral level within the past 6 months
• People with a history of heart disease who have been assessed as having Class I or II heart function by symptoms, or Category A or B by objective measurement, using a standard heart health classification system
• People who speak English or Spanish (for the quality-of-life part of the study)
• People who agree not to father children while participating in the trial
• People who, by the time of randomisation (the second step of joining), have completed a qualifying baseline PET scan with results known for cancer spread inside and outside the pelvis

Who may not be able to join:

• People who are currently enrolled in another clinical trial involving treatment
• People who have a history of seizures, or a condition that may increase seizure risk (such as a stroke or head injury causing loss of consciousness) within the past year
• People who have a history of inflammatory bowel disease or any bowel/digestive condition expected to increase the risk of complications from radiation therapy
• People who have previously completed a full course of pelvic radiation therapy for any reason
• People who have already started hormone therapy (ADT) for biochemical recurrence before their baseline PET scan
• People whose blood test results do not meet the required levels for blood counts, liver function, or kidney function (confirm specific values with trial site)
• People with heart disease who are assessed as Class III or IV, or Category C or D, on the standard heart health classification scale
• People who cannot lie flat and still long enough for a PET scan or radiation treatment planning and delivery
• People who have cancer that has spread to more than 5 sites outside the pelvis as seen on PET scan (confirm with trial site regarding how this affects eligibility)

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