RecruitingNot ApplicableNCT05948657

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

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

Sponsor

Weill Medical College of Cornell University

Enrollment

200 participants

Start Date

Feb 26, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

Summary

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.

Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria7

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.

Exclusion Criteria6

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.

Interventions

DIAGNOSTIC_TESTPSMA-PET CT

Patients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) at baseline, 12 month and 24 month time point.