Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Adenocarcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

* Baseline and annual systematic TRUS-guided biopsy performed as per standard of care by urologists for a total of one baseline diagnostic biopsy and two active surveillance systematic biopsies.
* mpMRI at the end of the 2nd year with targeted biopsy of any Prostate Imaging Reporting and Data System (PI-RADS) 4 or 5 lesion. Patients needing image- guided targeted biopsies will undergo this procedure by interventional radiology, which is a common standard of care at HHM VAMC.
* Optional transperineal template biopsy of the prostate performed at end of 2nd year (month 25-30).
* Patients will be followed, as per standard of care, for any potential infections from biopsies.
* Annual PSA tests performed as per routine standard of care.

* Baseline systematic transrectal ultrasound-guided biopsy performed as per standard of care by urologists.
* Baseline and annual mpMRI with targeted biopsy of any Prostate Imaging Reporting and Data System (PI-RADS) 4 or 5 lesion. Patients needing image- guided targeted biopsies will undergo this procedure by interventional radiology, which is a common standard of care at HHM VAMC.
* Optional transperineal template biopsy of the prostate performed at end of 2nd year (month 25-30).
* Patients will be followed, as per standard of care, for any potential infections from biopsies.
* Annual PSA tests performed as per routine standard of care.

Patients on the TRUS biopsy-based arm will undergo annual systematic biopsies without any MRI staging or guidance.

TRUS-guided biopsy

Patients on the mpMRI- based arm will undergo annual mpMRI surveillance imaging, with image-guided targeted biopsies only as indicated by radiographic findings.

mpMRI with targeted biopsy

Drew Moghanaki, MD, MPH

Phase II non-inferiority randomized trial of annual systematic biopsies versus mpMRI and targeted biopsies for men with low risk prostate cancer on active surveillance with any volume Gleason's Score 6, but no prior MRI imaging of the prostate.

This is an unblinded, randomized trial of TRUS biopsy-based active surveillance versus mpMRI-based active surveillance. Patients on the TRUS biopsy-based arm will undergo annual systematic biopsies without any MRI staging or guidance. Patients on the mpMRI- based arm will undergo annual mpMRI surveillance imaging, with image-guided targeted biopsies only as indicated by radiographic findings.

MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Ca

Multiparametric MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Cancer (MAVERICK)

To compare adherence with active surveillance requirements in Group 1 versus Group 2.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Ca	NCT02564549	Prostate Cancer Prostate Adenoc... Multiparametric... Gleason's Score...	TRUS-guided bio... mpMRI with targ...	40 Years -	Virginia Commonwealth University
MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Ca	NCT02564549	Prostate Cancer Prostate Adenoc... Multiparametric... Gleason's Score...	TRUS-guided bio... mpMRI with targ...	40 Years -	Virginia Commonwealth University

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