Prostate Cancer Clinical Trial

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

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.

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Full 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.

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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.
Ability to complete HRQOL surveys (EPIC, IPSS, IIEF-5).
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.

Study is for people with:

Prostate Cancer

Estimated Enrollment:

200

Study ID:

NCT05948657

Recruitment Status:

Recruiting

Sponsor:

Weill Medical College of Cornell University

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There are 5 Locations for this study

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UCLA
Los Angeles California, 90005, United States More Info
Pragya Yadav
Contact
646-962-2199
Wayne Brisbane, M.D.
Principal Investigator
UCSF
San Francisco California, 94143, United States More Info
Pragya Yadav
Contact
646-962-2199
[email protected]
Matthew Cooperberg, M.D.
Principal Investigator
Weill Cornell Medicine - New York Presbyterian Hospital
New York New York, 10065, United States More Info
Timothy McClure, M.D.
Contact
Timothy McClure, M.D.
Principal Investigator
Himanshu Nagar, M.D.
Principal Investigator
Case Western University Hospitals
Cleveland Ohio, 44106, United States More Info
Pragya Yadav
Contact
646-962-2199
[email protected]
Jonathan Shoag, M.D.
Principal Investigator
UT Southwestern
Dallas Texas, 75390, United States More Info
Pragya Yadav
Contact
646-962-2196
[email protected]
Sharanya Chandrasekhar
Contact
646-962-3110
[email protected]
Solomon Woldu, M.D.
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

200

Study ID:

NCT05948657

Recruitment Status:

Recruiting

Sponsor:


Weill Medical College of Cornell University

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