PSMA PET/MRI for Predicting and Detecting Prostate Cancer

Inclusion Criteria - Sub-study 1:

• Participant must be ≥ 18 years of age

• Participant must have an ECOG performance status ≤ 1.

• High risk disease (NCCN criteria Gleason 8-10 or PSA>20) or oligometastatic

• Histologic confirmation of prostate adenocarcinoma of the prostate gland, with or without evidence of metastases (oligometastatic <10 sites) on imaging by conventional imaging (MRI, CT, or 99mTc bone scan) or PSMA PET/CT

• Newly diagnosed disease with no prior treatment (surgery, radiation or systemic treatment, hormone therapy or chemotherapy) to the primary disease

  • Participants may have started LHRH agonist or antagonist therapy, and/or androgen receptor signaling inhibitor (ARSI) as long as it was not started more than 30 days before the patient is enrolled on this study

• Participants will have i) enrolled on the METANOVA trial or ii) have selected androgen deprivation therapy prior to surgery as their treatment of choice

• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria - Sub-study 1:

• Castration resistant prostate cancer (CRPC).

• Evidence of visceral or intracranial metastases.

• Participant receiving any other investigational agents for cancer.

• Participant is participating in a concurrent treatment protocol for cancer.

• Contraindications to MRI or intravenous contrast administration per institutional MRI safety screening including severe kidney disease, prior severe allergic reaction to gadolinium-based contrast, prior nephrogenic systemic fibrosis

• Unable to lie flat during or tolerate PET/MRI

• Prior definitive treatment to the primary prostate cancer or pelvis. Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes (HgA1c > 10), active pituitary or adrenal dysfunction, or psychiatric illness/social situations that would limit compliance with study requirements

• History of another active malignancy within the previous 2 years, except for non-melanoma skin cancer, non-muscle invasive bladder cancer, or a malignancy that is considered cured with minimal risk of recurrence.

• Active Crohn's disease or ulcerative colitis despite medical management.

• Refusal to sign informed consent.

• Any condition that in the opinion of the investigator would preclude participation in this study.

• Participants requiring intravenous (IV) conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI scan will be allowed to participate as long as the following criteria are met:

  1. The participant has their own prescription for the medication
  2. The informed consent process is conducted prior to the self-administration of the medication.
  3. The participant comes to the research visit with a driver or an alternative plan for transportation (e.g. Uber, taxi, etc.).

Inclusion Criteria - Sub-study 2:

• Male, 40-85 years of age

• New diagnosis of prostate cancer undergoing additional biopsy evaluation or high clinical suspicion of prostate cancer with elevated and rising PSA level.

• Participant with prostate cancer undergoing:

  • Reevaluation for progression on active surveillance or watchful waiting as manifest by rising PSA and/or change in digital-rectal exam OR
  • Participant on active surveillance or watchful waiting undergoing planned MRI/TRUS prostate biopsy for re-evaluation

• Meet criteria ranging from very low to intermediate risk group:

  • T1c to T2
  • Gleason-group (GG) 1 (Gleason score 6), GG2 (Gleason score 3+4) or GG3 (Gleason score 4+3) prostate adenocarcinoma
  • Any PSA permitted

• Karnofsky performance status of at least 70

• General health and anatomy suitable to undergo transrectal ultrasound-MRI fusion biopsy, as determined by SOC, of the identified lesions and standard 12 core sextent biopsy

• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria - Sub-study 2:

• Prior pelvic external beam radiation therapy or brachytherapy

• Chemotherapy for prostate cancer

• Androgen deprivation therapy for prostate cancer

• Unable to lie flat during or tolerate PET/MRI

• Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.

• Contraindications to MRI or intravenous contrast administration per institutional MRI safety screening including severe kidney disease, prior severe allergic reaction to gadolinium-based contrast, prior nephrogenic systemic fibrosis.

• Participants requiring intravenous (IV) conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI scan will be allowed to participate as long as the following criteria are met:

  1. The participant has their own prescription for the medication
  2. The informed consent process is conducted prior to the self-administration of the medication.
  3. The participant comes to the research visit with a driver or an alternative plan for transportation (e.g. Uber, taxi, etc.).