NCT05948657

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
31mo left

Started Feb 2024

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Feb 2024Dec 2028

First Submitted

Initial submission to the registry

June 20, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

February 26, 2024

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

4.8 years

First QC Date

June 20, 2023

Last Update Submit

April 28, 2026

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

  • Negative predictive value (NPV)

    Negative predictive value (NPV): The NPV is defined as the number of negative image results with identified clinically insignificant prostate cancer on biopsy divided by the number of negative image results.

    Baseline

  • Negative predictive value (NPV)

    Negative predictive value (NPV): The NPV is defined as the number of negative image results with identified clinically insignificant prostate cancer on biopsy divided by the number of negative image results.

    12 months

  • Negative predictive value (NPV)

    Negative predictive value (NPV): The NPV is defined as the number of negative image results with identified clinically insignificant prostate cancer on biopsy divided by the number of negative image results.

    24 months

Secondary Outcomes (33)

  • Positive predictive value (PPV) of PSMA PET.

    Baseline

  • Positive predictive value (PPV) of PSMA PET.

    12 months

  • Positive predictive value (PPV) of PSMA PET.

    24 months

  • Number of patients with negative PSMA pet scan.

    Baseline

  • Number of patients with negative PSMA pet scan.

    12 months

  • +28 more secondary outcomes

Study Arms (1)

PSMA-PET CT

OTHER

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

Diagnostic Test: PSMA-PET CT

Interventions

PSMA-PET CTDIAGNOSTIC_TEST

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

PSMA-PET CT

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UCLA

Los Angeles, California, 90005, United States

NOT YET RECRUITING

UCSF

San Francisco, California, 94143, United States

NOT YET RECRUITING

Weill Cornell Medicine - New York Presbyterian Hospital

New York, New York, 10065, United States

RECRUITING

UH Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Timothy McClure, M.D.

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Holly Kuczynski

CONTACT

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

Sarah Yuan

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Patients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) at baseline, 12 month and 24 month time point.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2023

First Posted

July 17, 2023

Study Start

February 26, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(4)