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

NCT02564549 | Terminated DMC

• 3 other identifiers: MCC-14-10633NCI-2015-0173902147
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

low risk prostate cancer

Outcome Measures

Primary Outcomes (1)

• To asses the detection rate of Gleason score ≥ 4+3 in patients with low-risk prostate cancer who undergo transrectal ultrasound (TRUS) biopsy-based active surveillance (Group 1) versus patients who undergo mpMRI-based active surveillance (Group 2).

  3 years

Secondary Outcomes (3)

• Percentage of patients in Group 1 versus Group 2 who remain on active surveillance from the time of randomization until the end of study participation.

  3 years

• To compare the rate of biopsy-related infections in Group 1 versus Group 2.

  3 years

• To compare the missed rate of occult Gleason score ≥ 4+3 by template biopsy at end of study in Group 1 versus Group 2.

  3 years

Study Arms (2)

Group 1 (TRUS-guided biopsy)

ACTIVE COMPARATOR

* 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.

Procedure: TRUS-guided biopsy

Group 2 (mpMRI with targeted biopsy)

EXPERIMENTAL

* 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.

Procedure: mpMRI with targeted biopsy

Interventions

TRUS-guided biopsy PROCEDURE

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

Group 1 (TRUS-guided biopsy)

mpMRI with targeted biopsy PROCEDURE

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

Group 2 (mpMRI with targeted biopsy)

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prostate adenocarcinoma diagnosed by biopsy within 12 months prior to study registration.
• Gleason score ≤ 6
• PSA \< 10 ng/mL

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Massey Cancer Center: collaborator
• Hunter Holmes Mcguire Veteran Affairs Medical Center: collaborator

Study Sites (1)

Hunter Holmes Mcguire Veteran Affairs Medical Center

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Drew Moghanaki, MD, MPH

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: September 30, 2015
• Study Start: October 5, 2015
• Primary Completion: June 28, 2016
• Study Completion: October 13, 2017
• Last Updated: October 19, 2017

Record last verified: 2017-10

Locations

US (1)