An Investigational Scan (rh PSMA 7.3 PET/MRI) for the Detection of Recurrent Disease and Aid in Radiotherapy Planning in Biochemically Recurrent Prostate Cancer

PRIMARY OBJECTIVE:

I. To evaluate the positive predictive value and detection rate of fluorine F 18 rhPSMA-7.3 (F-18 rhPSMA-7.3) positron emission tomography (PET)/magnetic resonance imaging (MRI) in detecting recurrent disease in prostate cancer patients with biochemical recurrence.

SECONDARY OBJECTIVE:

I. To determine the change in salvage radiation treatment plan after F-18 rhPSMA-7.3 PET/MRI imaging.

EXPLORATORY OBJECTIVES:

I. To assess the feasibility of utilizing the PSMA avid recurrent disease on PET/MRI as an alignment tool for MR guided radiotherapy (MR linear accelerator [MR-LINAC]).

II. To assess the treatment response in those patients who demonstrate rhPSMA-7.3 avid disease on the first PET/MRI scan.

OUTLINE:

Patients receive F-18 rhPSMA-7.3 intravenously (IV) and after approximately 60 minutes of uptake time, will undergo PET/MRI over 60 minutes. Patients with evidence of F-18 rhPSMA-7.3 disease in the first PET/MRI scan undergo a second F-18 rhPSMA-7.3 PET/MRI at 6 months after the second dose of standard hormonal therapy.

After completion of study treatment, patients are followed up within 7 days.

Inclusion criteria

• Patient is male and aged > 18 years old
• History of localized adenocarcinoma of the prostate status post (s/p) radical prostatectomy
• An initial elevated PSA >= 0.2 followed by a subsequent confirmatory PSA >= 0.2 clinically suspicious for biochemically recurrent disease
• If the patients were previously taking androgen deprivation therapy (ADT), it should be discontinued at least 12 weeks prior to the study
• Treatment plan includes salvage radiation with or without hormones.
• Patient willing to provide signed informed consent and willing to comply with all required study schedule events, where safe and feasible
• Non-English speaking patients may be enrolled.

Exclusion criteria

• Patients with any medical condition or circumstance that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements
• Patients who are planned to have an Iodinated contrast agent with computed tomography (CT) or gadolinium based contrast agent with MRI or other PET radiotracer < 24 hours prior to the PET scan
• Patients with contraindication to undergo MRI
• Patients with extreme claustrophobia
• Patients with prior allergy to MRI contrast agent
• Patients who are cognitively impaired