A Phase II, Prospective Study of MRI in the Reclassification of Men Considering Active Surveillance in Prostate Cancer

NCT01858688 | Completed Results DMC

• 1 other identifier: 13-056
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 2

Brief Summary

Some men newly diagnosed with prostate cancer do not require immediate treatment. Rather, they can be followed closely with regular physical exams, blood work and repeated biopsies of the prostate. If the prostate cancer is becoming more aggressive, curative treatment can be offered at that time. This strategy of delaying treatment until necessary is called active surveillance in prostate cancer. Active surveillance is a way of monitoring prostate cancer which aims to avoid or delay unnecessary treatment in men with less aggressive cancer. Prostate cancer can be slow growing and, for many men, the disease may never progress or cause any symptoms. In other words, many men with prostate cancer will never need any treatment. Treatments for prostate cancer may cause side effects which can affect your quality of life. By monitoring the cancer with regular tests, you can avoid or delay these side effects. Active surveillance is generally suitable for men with low risk early stage prostate cancer that is contained within the prostate gland (localized prostate cancer). If doctors had a better way of identifying who might be best suited for this approach, it would likely become more appealing for more men. In this study, the investigators are looking at how accurate a magnetic resonance imaging (MRI) scan is at identifying high-risk prostate cancer, which might make a man a poor candidate for active surveillance. To do this, the investigators are collecting data from the MRI scan of men and comparing it to a trans-rectal biopsy performed following the scan. The results of this study will help inform doctors how accurate the MRI is in identifying men who should not be on active surveillance.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; MRI; Active surveillance in prostate cancer

Outcome Measures

Primary Outcomes (2)

• MP-erMRI Classification Sensitivity

  The classification sensitivity of multiparametric endorectal magnetic resonance imaging (MP-erMRI) when compared to the standard of care procedure (transrectal ultrasound-guided (TRUS) re-biopsy) The sensitivity is equivalent to the proportion of patients who were reclassified by MP- erMRI out of the total number of patients who should have been reclassified (given their TRUS re-biopsy result). In other words, it is the proportion of participants reclassified appropriately by MP- erMRI.

  From baseline biopsy to final biopsy, up to 18 months

• MP- erMRI Classification Specificity

  The classification specificity of multiparametric endorectal magnetic resonance imaging (MP-erMRI) when compared to the standard of care procedure (transrectal ultrasound-guided (TRUS) re-biopsy) The specificity is equivalent to the proportion of patients who were not reclassified by MP- erMRI out of the total number of patients who should have been not reclassified (given their TRUS re-biopsy result). In other words, it is the proportion of participants not reclassified appropriately by MP- erMRI.

  From baseline biopsy to final biopsy, up to 18 months

Secondary Outcomes (7)

• Frequency of Reclassification

  From baseline biopsy to final MRI, up to 18 months

• Median Change in Illness-Related Uncertainty, Anxiety, and Distress

  From baseline biopsy to final MRI, up to 18 months

• Median Change in Service Satisfaction

  From baseline biopsy to final MRI, up to 18 months

• Median Change in Prostate Cancer Symptoms

  From baseline biopsy to final MRI, up to 18 months

• Median Change in Urinary Symptoms

  From baseline biopsy to final MRI, up to 18 months

Study Arms (1)

Accuracy of multi-parametric MRI relative to prostate biopsy

EXPERIMENTAL

Determine the sensitivity and specificity of MP-erMRI relative to repeat 12 core TRUS biopsy for classifying upgrading of disease extent or Gleason grade in men considering AS.

Device: Multiparametric MRI; Procedure: Prostate biopsy

Interventions

Multiparametric MRI DEVICE

an MRI of the prostate will be performed

Accuracy of multi-parametric MRI relative to prostate biopsy

Prostate biopsy PROCEDURE

a biopsy of the prostate will be performed according to standard procedures for men on active surveillance

Accuracy of multi-parametric MRI relative to prostate biopsy

Eligibility Criteria

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

You may qualify if:

• Participants must meet the following criteria on screening examination to be eligible to participate in the study:
• The subject will have histologically confirmed prostate cancer with all of the following features:
• Minimum 10 core prostate biopsy showing histologically-confirmed prostate cancer within 12 months of enrollment reviewed by a pathologist from one of the DF/HCC associated hospitals
• Gleason ≤3+3
• No tertiary Gleason grade ≥4
• ≤3 total cores positive
• ≤50% of any given core involved with cancer
• No evidence on biopsy of extracapsular extension
• PSA within one month of enrollment: \<10 ng/mL
• Clinical stage: ≤T2a \& N0 or NX \& M0
• The subject is able and willing to abide by the study protocol or cooperate fully with the investigator or designee
• The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document
• Age ≥18
• Life expectancy of greater than 10 years
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
• First diagnosis of prostate cancer \> 12 months prior to enrollment
• Prior prostate cancer-directed therapy including:
• androgen deprivation therapy
• radiation therapy to the prostate (external beam or brachytherapy)
• cryotherapy
• high-intensity focused ultrasound (HIFU)
• chemotherapy for prostate cancer
• Prior transurethral resection of prostate
• Subject who is deemed by the treating physician to have a contraindication to definitive treatment
• Subjects with a contraindication to an MRI including those with a pacemaker, ferromagnetic aneurysm clip, or cochlear implants
• Subjects with a contraindication to receiving Gadolinium containing contrast for the MRI
• Conditions which make repeat TRUS biopsies not feasible

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Neil Martin, MD
• Organization: Brigham and Women's Hospital/Dana-Farber Cancer Institute

NEMARTIN@PARTNERS.ORG

(617) 632-3000

Study Officials

• Neil E Martin, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Evaluation of accuracy of the MRI relative to biopsy

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 21, 2013
• Study Start: September 1, 2013
• Primary Completion: May 1, 2018
• Study Completion: April 1, 2023
• Last Updated: May 3, 2023
• Results First Posted: May 18, 2022

Record last verified: 2023-04

Locations

US (2)