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

> **NIH NIH R37** · WEILL MEDICAL COLL OF CORNELL UNIV · 2024 · $698,716

## Abstract

Prostate cancer (PCa) shows a striking degree of clinical variability, with most aging men harboring
indolent, low risk PCa that will not threaten their health during their natural lifetime. Definitive
treatment for these indolent, low risk cancers with surgery or radiation therapy (RT) risks unnecessary
cost and treatment-related toxicity. Because of this, active surveillance (AS), a management strategy
that avoids or defers treatment, has emerged as a standard of care for low risk PCa. AS consists of
monitoring low risk, clinically insignificant PCa patients, with treatment with curative intent ONLY with
progression to clinically significant PCa (csPCa). Determining when a patient progresses on AS
consists a variable mix of serial prostate specific antigen (PSA) measurements, imaging, and prostate
biopsies . However, no consensus exists as to the ideal set of tests and monitoring frequencies
during AS. Prostate biopsy itself has measurable morbidity and is associated with infection, urinary
retention, pain and worsening of urinary symptoms. There is therefore a need for optimization of AS
protocols and to improve the detection of csPCa for men on AS. Prostate imaging with magnetic
resonance imaging (MRI) has become an integral tool in the diagnosis of PCa and monitoring of men
on AS as it improves the detection of clinically significant PCa compared to prostate biopsy without
MRI targeting, however accuracy is limited. A negative MRI still misses approximately 20% of csPCa
and a positive MRI will result in a negative biopsy 50% of the time. Better imaging is required to
improve the detection of csPCa. Prostate Specific Membrane Antigen Positron Emission
Tomography-Computed Tomography (PSMA-PET CT) is the most sensitive technique available for
detection of metastatic prostate cancer. The accuracy of PSMA-PET CT in localized disease is
limited; however, it has been shown that PSMA-PET CT adds diagnostic value to prostate MRI for
detection of csPCa, specifically improving negative predictive value. We hypothesize that PSMA-PET
CT in AS patients will improve diagnostic accuracy of prostate MRI such that a negative study will
obviate the need for surveillance prostate biopsy. The Evaluation of Prostate Specific Membrane
Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate
CancEr (ESCAPE) trial is a single arm, prospective multi-institutional clinical trial assessing the
negative predictive value of PSMA PET CT in detecting clinically significant prostate cancer. We
hypothesize that PSMA-PET CT can rule out clinically significant prostate in AS patients due to its
high negative predictive value.

## Key facts

- **NIH application ID:** 10882982
- **Project number:** 1R37CA282407-01A1
- **Recipient organization:** WEILL MEDICAL COLL OF CORNELL UNIV
- **Principal Investigator:** Timothy Mcclure
- **Activity code:** R37 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $698,716
- **Award type:** 1
- **Project period:** 2024-04-01 → 2029-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10882982

## Citation

> US National Institutes of Health, RePORTER application 10882982, ESCAPE - Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate Cancer (1R37CA282407-01A1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10882982. Licensed CC0.

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