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

Status: Recruiting
Phase: Phase 2
Diagnosis: Prostate Cancer
NCT ID: NCT01858688 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-056

 

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.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Neil Martin, MD, MPH, Dana Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Amanda Fredericks, 617-632-5514, acfredericks@partners.org
Dana-Farber Cancer Institute: Judith Prisby, 617-632-5068, jprisby@partners.org
Dana-Farber Cancer Institute: Meghara Walsh, 617-632-5264, mwalsh10@partners.org

Eligibility Criteria

Inclusion Criteria: - 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. Exclusion Criteria: - 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
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