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Recruiting NCT05948657

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

No phase Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PSMA-PET CT.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Diagnostic test 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 measures

  • Negative predictive value (NPV) [Time frame: Baseline]
  • Negative predictive value (NPV) [Time frame: 12 months]
  • Negative predictive value (NPV) [Time frame: 24 months]
Secondary outcome measures (12)
  • Positive predictive value (PPV) of PSMA PET. [Time frame: Baseline]
  • Positive predictive value (PPV) of PSMA PET. [Time frame: 12 months]
  • Positive predictive value (PPV) of PSMA PET. [Time frame: 24 months]
  • Number of patients with negative PSMA pet scan. [Time frame: Baseline]
  • Number of patients with negative PSMA pet scan. [Time frame: 12 months]
  • Number of patients with negative PSMA pet scan. [Time frame: 24 months]
  • Number of positive scans on mpMRI [Time frame: Baseline]
  • Number of positive scans on mpMRI [Time frame: 12 months]
  • Number of positive scans on mpMRI [Time frame: 24 months]
  • Number of positive scans on PSMA-PET [Time frame: Baseline]
  • Number of positive scans on PSMA-PET [Time frame: 12 months]
  • Number of positive scans on PSMA-PET [Time frame: 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 4 centers
  • UCLA — Los Angeles
  • UCSF — San Francisco
  • Weill Cornell Medicine - New York Presbyterian Hospital — New York
  • UH Cleveland Medical Center — Cleveland

Identifiers

NCT: NCT05948657 · 23-03025893

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗