Prostate CancerESCAPENCT05948657
Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr
A study testing PSMA-PET CT in people with Prostate Cancer, run by Weill Medical College of Cornell University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PSMA-PET CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Feb 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
UH Cleveland Medical Center
Cleveland, Ohio, 44106
Matt Ferrebee, Matthew.Ferrebee@UHhospitals.org
Jonathan Shoag, M.D.
- Not yet recruiting
UCLA
Los Angeles, California, 90005
Sarah Yuan, say7008@med.cornell.edu
Wayne Brisbane, M.D.
- Recruiting
Weill Cornell Medicine - New York Presbyterian Hospital
New York, New York, 10065
Timothy McClure, M.D., tim9047@med.cornell.edu
Timothy McClure, M.D.
- Not yet recruiting
UCSF
San Francisco, California, 94143
Sarah Yuan, say7008@med.cornell.edu
Matthew Cooperberg, M.D.
About this study
Official title: ESCAPE - Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- PSMA-PET CT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: PSMA-PET CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 24 months
Secondary outcomes (33)
Positive predictive value (PPV) of PSMA PET.
PPV of PSMA PET. Positive predictive value (PPV): The PPV is defined as the number of positive image results with identified csPCa on biopsy divided by the number of positive image results.
Measured: Baseline
Positive predictive value (PPV) of PSMA PET.
PPV of PSMA PET. Positive predictive value (PPV): The PPV is defined as the number of positive image results with identified csPCa on biopsy divided by the number of positive image results.
Measured: 12 months
Positive predictive value (PPV) of PSMA PET.
PPV of PSMA PET. Positive predictive value (PPV): The PPV is defined as the number of positive image results with identified csPCa on biopsy divided by the number of positive image results.
Measured: 24 months
Number of patients with negative PSMA pet scan.
Measured: Baseline
Number of patients with negative PSMA pet scan.
Measured: 12 months
Number of patients with negative PSMA pet scan.
Measured: 24 months
Number of positive scans on mpMRI
Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.
Measured: Baseline
Number of positive scans on mpMRI
Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.
Measured: 12 months
Number of positive scans on mpMRI
Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.
Measured: 24 months
Number of positive scans on PSMA-PET
Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.
Measured: Baseline
Number of positive scans on PSMA-PET
Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.
Measured: 12 months
Number of positive scans on PSMA-PET
Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.
Measured: 24 months
Number of positive scans on both PSMA-PET and mpMRI
Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.
Measured: Baseline
Number of positive scans on both PSMA-PET and mpMRI
Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.
Measured: 12 months
Number of positive scans on both PSMA-PET and mpMRI
Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.
Measured: 24 months
Number of negative scans on mpMRI
Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.
Measured: Baseline
Number of negative scans on mpMRI
Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.
Measured: 12 months
Number of negative scans on mpMRI
Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.
Measured: 24 months
Number of negative scans on PSMA-PET
Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.
Measured: Baseline
Number of negative scans on PSMA-PET
Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.
Measured: 12 months
Number of negative scans on PSMA-PET
Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.
Measured: 24 months
Number of negative scans on both PSMA-PET and mpMRI
Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.
Measured: Baseline
Number of negative scans on both PSMA-PET and mpMRI
Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.
Measured: 12 months
Number of negative scans on both PSMA-PET and mpMRI
Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.
Measured: 24 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.
The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.
Measured: Baseline
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.
The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.
Measured: 12 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.
The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.
Measured: 24 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.
The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.
Measured: Baseline
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.
The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.
Measured: 12 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.
The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.
Measured: 24 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.
The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.
Measured: Baseline
Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.
The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.
Measured: 12 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.
The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start26 Feb 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) at baseline, 12 month and 24 month time point.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy McClure, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948657
- Sponsor's protocol ID
- 23-03025893
- Acronym
- ESCAPE
- Status last verified
- Apr 2026
- First submitted
- 20 Jun 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESCAPE - Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr
- ClinicalTrials.gov ID
- NCT05948657
- Acronym / sponsor ID
- ESCAPE / 23-03025893
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) at baseline, 12 month and 24 month time point.
| Arm | Type | Receives |
|---|---|---|
| PSMA-PET CT | Other | Diagnostic Test: PSMA-PET CTPatients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) at baseline, 12 month and 24 month time point. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSMA-PET CTPatients 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 |
Primary outcome
Negative predictive value (NPV)
Time frame: Baseline
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.
Negative predictive value (NPV)
Time frame: 12 months
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.
Negative predictive value (NPV)
Time frame: 24 months
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.
33 secondary outcomes
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
Number of positive scans on both PSMA-PET and mpMRI
Time frame: Baseline
Number of positive scans on both PSMA-PET and mpMRI
Time frame: 12 months
Number of positive scans on both PSMA-PET and mpMRI
Time frame: 24 months
Number of negative scans on mpMRI
Time frame: Baseline
Number of negative scans on mpMRI
Time frame: 12 months
Number of negative scans on mpMRI
Time frame: 24 months
Number of negative scans on PSMA-PET
Time frame: Baseline
Number of negative scans on PSMA-PET
Time frame: 12 months
Number of negative scans on PSMA-PET
Time frame: 24 months
Number of negative scans on both PSMA-PET and mpMRI
Time frame: Baseline
Number of negative scans on both PSMA-PET and mpMRI
Time frame: 12 months
Number of negative scans on both PSMA-PET and mpMRI
Time frame: 24 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.
Time frame: Baseline
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.
Time frame: 12 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.
Time frame: 24 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.
Time frame: Baseline
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.
Time frame: 12 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.
Time frame: 24 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.
Time frame: Baseline
Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.
Time frame: 12 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timothy McClure, M.D. principal investigator
Weill Medical College of Cornell University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSMA-PET CT in people with Prostate Cancer, run by Weill Medical College of Cornell University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Holly Kuczynski (646-962-7523, hok4001@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative predictive value (NPV) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.