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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
Health authority
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.

Study Design


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
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