Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr

Recruiting now · Not applicable

Conditions studied: Prostate Cancer

In brief

This study will be assessing the ability of PSMA-PET CT to determine the absence of clinically significant prostate cancer in patients on active surveillance (AS) with low risk and favorable intermediate-risk prostate cancer.

Key facts

Study ID

NCT05948657

Run by

Weill Medical College of Cornell University

People needed

200

Starts

2024-02-26

Expected to finish

2028-12-01

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males aged ≥ 18.
• Histologically confirmed low or favorable intermediate risk prostate cancer per NCCN guidelines. (Note: Grade Group 2 must have 20% or less involvement in every core and no presence of cribiform or intraductal carcinoma).
• PSA < 20 ng/ml.
• Ability to undergo yearly PSMA-PET CT.
• Ability to undergo yearly prostate mpMRI.
• Ability to undergo transrectal or transperineal template and fusion prostate biopsy.
• Willingness to undergo yearly prostate biopsies.

You may not qualify if…

• History of prior treatment for prostate cancer.
• History of systemic therapy for prostate cancer.
• Inability to undergo transrectal ultrasound.
• Life expectancy less than 10 years.
• Not interested in pursuing active surveillance.
• Initial diagnosis of prostate cancer greater than 15 months.

Where it is running

• Weill Cornell Medicine - New York Presbyterian Hospital — New York, New York, United States (enrolling)
• UH Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• UCLA — Los Angeles, California, United States
• UCSF — San Francisco, California, United States

Full record on ClinicalTrials.gov

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