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Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and at Risk of Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03823001
Recruitment Status : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:
The purpose of this study is to examine the use of MRI surveillance for patients with no prostate cancer, potential prostate cancer, or diagnosed low-grade prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Diagnostic Test: virtual biopsy (VB) monitoring protocol Not Applicable

Detailed Description:
This study will use MRI instead of prostate biopsy in combination with regularly scheduled urologist visits, interval PSA checks, and annual DRE to help establish a non-invasive method for 1) participants with a negative prostate MRI (PI-RADS 1 or 2) who have never had a biopsy; 2) participants with a positive MRI (PI-RADS score of 3, 4, or 5) and negative MRI-targeted biopsy pathology; and 3) monitoring participants with clinically diagnosed low risk prostate cancer who are on active surveillance. However, if at any point, clinical suspicion indicated either by the presence of suspicious lesions on the MRI, rising PSA, and/or positive DRE arises, then an immediate biopsy will be performed.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of a Novel, Non-Invasive Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and Patients at Risk of Harboring Low-Risk Prostate Cancer: A Prospective Non-Randomized Clinical Trial
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Virtual prostate biopsy (VB) monitoring

Prostate-specific antigen (PSA) and digital rectal exam (DRE) are standard of care for monitoring patients on active surveillance or at risk of having low-risk prostate cancer. A novel virtual biopsy (VB) monitoring protocol will be implemented:

  1. PSA bi-annually or more often according to the discretion of the urologist.
  2. Annual DRE.
  3. Visit with the urologist bi-annually.
  4. Multi-parametric MRI (mpMRI) every year for 3 years.
  5. Transrectal ultrasound (TRUS) biopsy at the end of the 3rd year.
Diagnostic Test: virtual biopsy (VB) monitoring protocol
  1. PSA bi-annually or more often according to the discretion of the urologist.
  2. Annual DRE.
  3. Visit with the urologist bi-annually.
  4. Multi-parametric MRI (mpMRI) every year for 3 years.
  5. Transrectal ultrasound (TRUS) biopsy at the end of the 3rd year.




Primary Outcome Measures :
  1. Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria) [ Time Frame: Up to 3 years from start of study ]
    Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria). This metric will determine if the the VB protocol is statistically equal to (or greater than) the negative predictive value of the standard of care TRUS prostate biopsy.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy-naive patients with a negative prostate MRI (PI-RADS score 1 or 2); or
  • Patients with a PI-RADS score of 3, 4, or 5 on MRI and a negative MR-targeted biopsy; or
  • Patients on active surveillance with a negative prostate MRI (PI-RADS 1 or 2).

Exclusion Criteria:

  • Positive DRE;
  • PSA > 10 ng/ml or unstable PSA (doubling time <3 years) during the last year prior to enrolling in this study;
  • PSAD > 0.15 (calculated using most recent PSA divided by MRI prostate volume);
  • First degree relative diagnosed with prostate cancer
  • First degree relative diagnosed with a BRCA2 or Lynch syndrome associated gene causing any cancer.
  • Patient carries a mutation on BRCA2 or a mismatch repair gene associated with Lynch syndrome (MLHl, MSH2, MSH6, PMS2); known BRCA2 or known mismatch repair gene mutation in the family (Lynch Syndrome) and patient has not had testing; or family history consistent with BRCA2 or Lynch syndrome and there is no known BRCA2 or mismatch repair gene in the family.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823001


Contacts
Contact: Lee Ponsky 1-800-641-2422 CTUReferral@UHhospitals.org

Locations
United States, Ohio
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: Lee Ponsky    800-641-2422    CTUReferral@UHhospitals.org   
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Lee Ponsky University Hospitals Cleveland Medical Center

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03823001     History of Changes
Other Study ID Numbers: CASE9818
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Case Comprehensive Cancer Center:
Magnetic Resonance Imaging (MRI)

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases