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 low or intermediate risk prostate cancer, confirmed by a tissue sample (biopsy), with the diagnosis verified by the NIH Laboratory of Pathology.
• People whose prostate cancer appears in only one single spot, as seen on both MRI and a special nuclear medicine scan (PSMA PET/CT), and confirmed by a targeted biopsy of that spot.
• People aged 18 or older.
• People who are reasonably active and able to care for themselves, with only limited physical restrictions (confirm with trial site).
• Men who agree to use effective contraception with their partner — such as barrier methods or abstinence — throughout the study and for up to 120 days after the last radiation treatment.
• People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

• People whose prostate cancer is classified as high risk — meaning a Gleason score of 8 or higher, advanced tumour spread beyond a certain stage, or a PSA blood test result of 20 ng/mL or higher.
• People whose biopsy results show a certain level of cancer (grade group 2 or higher) found outside the area visible on imaging scans.
• People who are planned to receive hormone therapy (to reduce testosterone) or chemotherapy at the same time as this study treatment.
• People who are currently taking part in another clinical trial involving an experimental treatment.
• People whose cancer has spread to the pelvis or other parts of the body, as found on pre-treatment scans.
• People with a urinary symptom score above 18 on a standard questionnaire (confirm with trial site).
• People who have previously had any curative treatment for prostate cancer, whether for a past or current diagnosis.
• People with an active urinary tract infection at the time of enrolment.
• People living with HIV who are not on effective HIV medication, or whose virus levels have not been undetectable within the 6 months before registering for the trial.
• People with a hepatitis B (HBV) infection that has not been treated and cleared.
• People with ongoing hepatitis B who do not have undetectable virus levels while on suppressive treatment.
• People with a hepatitis C (HCV) infection that has not been treated and cleared.
• People currently being treated for hepatitis C who do not have undetectable virus levels at the time of screening.
• People where the location of the tumour in relation to surrounding healthy tissue makes the planned treatment technically not feasible, as assessed by the lead investigator.
• People with connective tissue diseases (conditions affecting the body's structural tissues, such as lupus or scleroderma — confirm with trial site).
• People with conditions that make them unusually sensitive to radiation.
• People with active inflammatory bowel disease in the area where radiation would be directed.
• People with past medical conditions or prior pelvic surgery that are expected to significantly increase the risk of side effects from the radiation treatment.
• People who are unable or unwilling to have a contrast-enhanced MRI scan — for example, due to poor kidney function (eGFR below 30), severe claustrophobia, body weight above 350 lbs., body size that does not fit the scanner, or implanted devices that are not compatible with MRI (such as certain heart devices, surgical metal implants, shrapnel, brain aneurysm clips, or similar items).
• People who are unwilling to have a specific type of PET/CT scan (using a tracer called 18F-DCFPyL), or who have a known allergy to that tracer.
• People for whom the placement of small internal markers used to guide radiation (fiducial markers) is not possible or medically inadvisable.
• People who have previously had radiotherapy in the same area of the body that would be treated in this trial.
• People with uncontrolled illness, or personal or social circumstances that would make it difficult to follow the study requirements.

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