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 aged 18 or older.
• People who are able to give informed consent to participate.
• People who are generally well enough to carry out daily activities with little or no limitation (this is measured using a standard medical scale called ECOG, scores 0–2).
• People who are well enough to complete all parts of the trial treatment and follow-up appointments.
• People with a life expectancy of more than 5 years.
• People with a confirmed prostate cancer diagnosis (a specific type called adenocarcinoma), classified as low or intermediate risk according to standard medical guidelines (NCCN), with a biopsy taken within the last 18 months. Low risk means the cancer is at an early, localised stage with a Gleason score of 6 or less and a PSA below 10 ng/mL. Intermediate risk means at least one of: a slightly more advanced localised stage (cT2b/T2c), a PSA between 10–20 ng/mL, or a Gleason score of 7, but not classified as high risk (confirm with trial site).
• People with a higher-tier intermediate risk disease (called "unfavourable intermediate risk") may also be eligible, and in these cases, 6 months of hormone therapy (called ADT, which lowers testosterone) is permitted as part of treatment.
• For those already started on ADT before joining the trial, this is permitted provided radiation treatment can be completed before the 6 months of ADT is finished.
• People whose prostate gland measures less than 100cc in size, based on imaging or physical examination.
• People who have had a PSA blood test within the 90 days before registering for the trial (or within 90 days before the first ADT injection, if hormone therapy was started before registration).
• People who have had a CT scan of the abdomen and pelvis within 6 months before registration (this may not be required for low-risk participants — confirm with trial site).
• People who have had a bone scan within 6 months before registration (this may not be required for low-risk participants — confirm with trial site).
• People who are willing and suitable to have small markers (called fiducial markers) and a gel spacer (called Space OAR Hydrogel) inserted into the prostate area as part of the radiation treatment process.

Who may not be able to join:

• People whose cancer has reached a more advanced local stage (cT3 or higher).
• People with a Gleason score of 8 or higher.
• People with a PSA level above 20 ng/mL.
• People whose cancer is classified as high or very high risk under standard guidelines.
• People whose cancer has spread to lymph nodes in the pelvis.
• People whose cancer has spread to other parts of the body (distant metastases).
• People who have had another cancer within the last 5 years, except for certain common skin cancers (basal cell or squamous cell carcinoma of the skin).
• People who have previously had radiotherapy to the pelvic area.
• People who have previously had any active treatment directly targeting the prostate (note: people who were on active surveillance without receiving treatment may still be eligible if all other criteria are met).
• People who have a hip replacement on one or both sides.
• People with medical conditions that would make radiotherapy unsafe, such as inflammatory bowel disease.
• People with a medical condition that would make it unsafe to have the fiducial markers or gel spacer inserted, as determined by the treating doctor (for example, an abscess in or near the prostate).
• People with a medical condition or implanted device that prevents them from having an MRI scan, such as a pacemaker.
• People who have had certain prostate procedures (TURP, GreenLight Laser, or Holmium Laser procedures) within 6 months of starting radiotherapy.

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