PSMA-PET/MRI Low- and Intermediate-Risk Prostate Cancer

• Status: Not yet recruiting
• Trial end date: 2028-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The goal of this study is to determine the safety of using PSMA-PET/mpMRI to define radiotherapy targets, while meeting all current planning criteria. This study also intends to determine the feasibility of performing stereotactic body radiation therapy with simultaneous integrated boost on the dominant intra-prostatic lesions while meeting all current planning criteria.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Treatments: Edetic Acid

Criteria

Inclusion Criteria:

• Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information

• Male subjects ≥ 18 years of age

• Histologically confirmed prostate adenocarcinoma

• Low or favorable intermediate risk, based on the NCCN criteria

• Subject has adequate performance status as defined by ECOG performance status of 0-2

• Subject is willing and able to comply with the protocol as determined by the Treating Investigator

• Subject speaks English (quality of life instrument is validated in English)

Exclusion Criteria:

• Contraindications for MRI

• Other prior or concomitant malignancies, with the exception of:

• non-melanoma skin cancer

• other cancer for which the subject has been disease free for ≥5 years before the first study treatment and of low potential risk for recurrence

• Inflammatory bowel disease

• Previous transurethral resection of the prostate (TURP) or surgery of the prostate