Summary

Eligibility
for males ages 18-90 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Matthew Cooperberg, M.D.
Headshot of Matthew Cooperberg
Matthew Cooperberg

Description

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.

Official Title

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

Details

This is a prospective, multicenter, nonrandomized single-arm study assessing the diagnostic accuracy of PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) in determining the absence of clinically significant prostate cancer in patients on active surveillance (AS).The trial will enroll 200 subjects for low and favorable intermediate-risk prostate cancer patients per NCCN guidelines who have elected to pursue active surveillance.

Keywords

Prostate Cancer, Prostatic Neoplasms, PSMA-PET CT

Eligibility

You can join if…

Open to males ages 18-90

  • 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.
  • Ability to complete HRQOL surveys (EPIC, IPSS, IIEF-5).
  • Willingness to undergo yearly prostate biopsies.

You CAN'T join 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.

Locations

  • UCSF not yet accepting patients
    San Francisco California 94143 United States
  • UCLA not yet accepting patients
    Los Angeles California 90005 United States
  • Weill Cornell Medicine - New York Presbyterian Hospital accepting new patients
    New York New York 10065 United States

Lead Scientist at UCSF

  • Matthew Cooperberg, M.D.
    Both clinician and patient decisions influence the choices about the type of treatment a patient will receive for localized prostate and kidney (renal) cancer. Matthew Cooperberg, MD, MPH is conducting an ongoing research program to study national prostate cancer management trends, based on data from CaPSURE and other sources.

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Weill Medical College of Cornell University
ID
NCT05948657
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated