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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02564549
• Other study ID #: MCC-14-10633
• Secondary ID: NCI-2015-0173902
• Status: Terminated
• Phase: N/A
• First received: September 28, 2015
• Last updated: October 17, 2017
• Start date: October 5, 2015
• Est. completion date: October 13, 2017

Study information

• Verified date: October 2017
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: October 13, 2017
• Est. primary completion date: June 28, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Gleason's Score 6
• Multiparametric MRI
• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• TRUS-guided biopsy
Patients on the TRUS biopsy-based arm will undergo annual systematic biopsies without any MRI staging or guidance.
• mpMRI with targeted biopsy
Patients on the mpMRI- based arm will undergo annual mpMRI surveillance imaging, with image-guided targeted biopsies only as indicated by radiographic findings.

Locations

Country	Name	City	State
United States	Hunter Holmes Mcguire Veteran Affairs Medical Center	Richmond	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Hunter Holmes Mcguire Veteran Affairs Medical Center, Massey Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	To compare adherence with active surveillance requirements in Group 1 versus Group 2.	3 years
Secondary	To compare the rate of biopsy-related infections in Group 1 versus Group 2.		3 years
Secondary	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