Imaging methods and agents for grading and staging and subsequent treatment of prostate cancer in a patient

A method of treating prostate cancer in a patient population of prostate cancer patients who have been previously graded as having favorable intermediate risk (FIR) prostate cancer or who have been previously assigned less than a grade 3 PCa on the International Society of Urological Pathology (ISUP) grading system and who are currently being treated with active surveillance therapy, comprising the steps of (i) administering piflufolastat F18 to an FIR prostate cancer patient population of at least 2 patients graded as having FIR prostate cancer;

• (ii) imaging the patients in the patient population, optionally within 1-4 hours, after injection of piflufolastat F18 by PET/CT or PET/MRI;
• (iii) obtaining the PET/CT or PET/MRI image from each of the patients in the patient population wherein at least 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75% or more of the patients in the patient population have images that identify an extraprostatic extension (EPE), seminal vesicle invasion (SVI), lymph node involvement (LNI), or ISUP grade ≥3 PCa, and (iv) changing the treatment of one or more patients in the patient population from active surveillance therapy to active therapy if the patient's image identifies an extraprostatic extension (EPE), seminal vesicle invasion (SVI), lymph node involvement (LNI), or ISUP grade ≥3 PCa.