Radioactive drugs before prostate surgery for high-risk prostate cancer

Who can take part

• You must be 18 years or older.
• You must have biopsy-confirmed prostate adenocarcinoma.
• You must have at least one high-risk feature: Gleason score 4+4 or higher, or 4+3 with large cribriform pattern, pelvic lymph node spread seen on PSMA PET, or cancer extending outside the prostate on MRI or PSMA PET.
• You must have no distant metastases (cancer spread to organs like bones or lungs) – only pelvic lymph node spread is allowed.
• If you are in a treatment group, the main prostate tumor must have a high PSMA signal (SUVmax > 10) on PSMA PET, and the tumor must be larger than 1 cm on MRI.
• You must be a candidate for and willing to undergo prostate removal surgery (prostatectomy), with or without lymph node dissection.
• Your blood counts and organ function must be adequate: platelets ≥ 100,000, hemoglobin ≥ 10 g/dL, neutrophils ≥ 1,500, creatinine clearance (GFR) ≥ 60 mL/min, albumin ≥ 2.5 g/dL, liver enzymes ≤ 3 times upper normal limit, and bilirubin ≤ 2 times upper normal limit (or ≤ 3 times if you have Gilbert's syndrome).
• You must agree to follow radiation safety precautions, avoid pregnancy, and not father a child during treatment and for at least 14 weeks after.
• You must not have other active cancers (unless treated and disease-free for over 3 years, or non-melanoma skin cancer or superficial bladder cancer).
• You must not have serious medical conditions that could interfere, such as uncontrolled heart failure, congenital long QT syndrome, uncontrolled infection, or active hepatitis B or C.
• You must not have had prior prostate cancer therapy, except that 5-alpha reductase inhibitors (like finasteride) are allowed if stopped at least 3 weeks before starting treatment.
• You must not have had prior external beam radiation to the prostate.
• You must not have severe dry mouth affecting eating.
• If you will receive the therapy through a vein (intraarterial), you must not have a severe allergy to iodinated contrast or severe atherosclerosis, and if you smoke, you must have had a prior imaging test.