PRISM Study: Prostate Recurrence Detection Using Imaging With PSMA PET/MRI Post-high Intensity Focused Ultrasound

NYU Langone Health

Status: Enrolling

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT07184970

24-01935

Details and patient eligibility

About

The purpose of this study is to compare the sensitivity of PSMA PET/MRI and standard MRI in detecting focal therapy failure in the prostate one year after High-Intensity Focused Ultrasound (HIFU) treatment. Specifically, the study aims to evaluate whether PSMA PET/MRI offers a higher sensitivity than MRI alone for identifying recurrence or failure in patients undergoing focal therapy.

Enrollment: 60 estimated patients

Sex: Male

Ages: 40 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male patients 40-95 years of age with biopsy-confirmed localized prostate cancer.
• Grade Group ≥2 (Gleason score 3+4 or higher).
• Unifocal disease visible on mpMRI.
• Patients undergoing HIFU as part of their standard of care
• PSA <20 ng/mL.
• No metastatic disease on PSMA PET/CT
• Willingness to comply with follow-up protocols (PSA testing, imaging, biopsies).

Exclusion criteria

• Evidence of metastatic disease on PSMA PET/CT.
• Allergy to POSLUMA or gadolinium.
• Inability to tolerate MRI due to claustrophobia or posture/back-hip issues.

Trial design

60 participants in 1 patient group

Men with Prostate Cancer

Description:

Patients undergoing High-Intensity Focused Ultrasound (HIFU) for focal therapy of prostate cancer. Participants will be followed for one-year post-treatment, with regular monitoring through various clinical assessments.