PSMA-PET Directed Radiation Therapy for High-Risk Prostate Cancer

Prior treatment

• Inability to complete the investigational imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).
• Patients who have initiated therapy (ADT, systemic therapy, or radiation) for their prostate cancer prior to PSMA-PET imaging.
• History of prostatectomy or previous pelvic radiotherapy.

Other illness

• Any additional medical condition, serious inter-current illness or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study performance, interpretation, or compliance with radiation
• History of inflammatory bowel disease, anal stenosis, colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases.

Age

• Previous malignancy within the last five years, except BCC or SCC skin or a malignancy treated curatively with no evidence of disease for ≥5 years.

Other

• Bilateral hip prostheses will be ineligible for study

• PSMA-N0M0 patients who have a documented history of High Risk localized adenocarcinoma of the prostate are eligible to participate if they meet the following eligibility criteria:
• Participants capable of giving written informed consent.
• Male.
• Age ≥18 years.
• ECOG ≤2.
• Patient has histologically proven adenocarcinoma of prostate gland with an assigned Gleason score and Gleason Grade Group.
• ≥NCCN High-Risk localized disease as per standard imaging investigations including pelvic imaging (CT, MRI) and 99Tc bone scan. High Risk prostate cancer defined as any of the following: cT3-T4 disease OR PSA ≥20 ng/ml OR Gleason grade group 4 or 5.
• No documentation of regional nodal (N1) or metastatic (M1) prostate cancer on standard imaging (CT, MRI, or 99Tc bone scan).
• In the opinion of the treating oncologist, patient is fit to undergo radical external beam radiotherapy to the prostate.
• Patient commits to androgen suppression treatment as per standard of care. 10. Patient is willing to complete symptom and patient reported outcome questionnaires.
  • 11\. Patients of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 6 months after the last dose of radiation therapy. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.
  • Male patients should agree to not donate sperm during the study and for 6 months after completion of radiation therapy.