Recruiting

PSMA PET-CT

Sponsor:

Weill Medical College of Cornell University

Code:

NCT05948657

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PSMA-PET CT

Study Details

Brief 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.

Conditions

Prostate Cancer

Study ID

NCT05948657

Start date

Feb 26, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: PSMA-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.

Interventions

PSMA-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.

Primary outcome measure

  • Negative predictive value (NPV) [ Time Frame: Baseline ]
  • Negative predictive value (NPV) [ Time Frame: 12 months ]
  • Negative predictive value (NPV) [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Holly Kuczynski

646-962-7523hok4001@med.cornell.edu

Sarah Yuan

646-962-6040say7008@med.cornell.edu

Locations

Weill Cornell Medicine - New York Presbyterian Hospital

Recruiting

New York, New York, United States, 10065

Contacts

Timothy McClure, M.D.

tim9047@med.cornell.edu

Principal Investigator:

Timothy McClure, M.D.

UH Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Matt Ferrebee

Matthew.Ferrebee@UHhospitals.org

Principal Investigator:

Jonathan Shoag, M.D.

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

May 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-05-04.