Recruiting

PSMA PET/MRI vs. MRI

Sponsor:

NYU Langone Health

Code:

NCT07184970

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT07184970

Start date

Oct 8, 2025

Status verified date

Aug, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Men with Prostate Cancer

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.

Primary outcome measure

  • Sensitivity of PSMA PET/MRI [ Time Frame: Month 12 ]
  • Oncologic Control [ Time Frame: Month 12 ]

Central Contacts and Locations

Central contacts

Majlinda Tafa

(646) 825-6338Majlinda.Tafa@nyulangone.org

Wei Phin Tan, MD

(646) 825-6325weiphin.tan@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-08-27.