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

Virginia Commonwealth University (VCU)

Status: Terminated

Conditions: Prostate Adenocarcinoma; Multiparametric MRI; Gleason's Score 6; Prostate Cancer

Treatments: Procedure: TRUS-guided biopsy; Procedure: mpMRI with targeted biopsy

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02564549

NCI-2015-01739 (Registry Identifier)

MCC-14-10633

02147 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 28 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prostate adenocarcinoma diagnosed by biopsy within 12 months prior to study registration.
• Gleason score ≤ 6
• PSA < 10 ng/mL
• Completed and documented history and physical addressing all inclusion/exclusion criteria.

Exclusion criteria

• A diagnosis of prostate adenocarcinoma on more than one set of prostate biopsies, on separate calendar dates.
• Previous MRI imaging of the prostate.
• Prior history of pelvic radiotherapy.
• Prior history of prostatectomy.
• Contraindication to prostate mpMRI (renal failure, hip prosthesis, pacemaker, etc).
• Contraindication to prostate biopsy via transrectal or transperineal approaches (including coagulopathy).
• Patients on testosterone replacement therapy who are unwilling to discontinue.
• Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements.
• Unable to understand, or unwilling to complete the informed consent process.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Group 1 (TRUS-guided biopsy)

Active Comparator group

Description:

* 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.

Treatment:

Procedure: TRUS-guided biopsy

Group 2 (mpMRI with targeted biopsy)

Experimental group

Description:

* 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.

Treatment:

Procedure: mpMRI with targeted biopsy