Early Changes In Multiparametric MRI In Prostate Cancer

Status: Recruiting
Phase: N/A
Diagnosis: Prostate Cancer
NCT ID: NCT01959542 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-343

 

In this research study, the investigators are trying to determine if there are measurable changes in prostate MRI that will help predict those who will or will not respond to Androgen Deprivation Therapy (ADT) and External Beam Radiation Therapy (EBRT) The first baseline prostate MRI prior to the start of treatment is standard of care. The participant's ADT/EBRT treatment is also standard of care, as advised by their doctor. It is the 3 follow up prostate MRIs during ADT/EBRT treatment, and 4 follow up serum PSA levels that are part of this research study.

 

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

Overall PI:
Fiona Fennessy, MD, Dana Faber 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: - Adult males with unfavorable intermediate- to high-risk localized disease, defined as: - Clinical or radiographic T2b-T4 primary tumor - Gleason score 7-10 in any core - PSA ≥ 10 prior to initiation of therapy - Patients are deemed suitable for therapy with ADT and EBRT. - Subjects must to able to provide informed written consent prior to study entry. Exclusion Criteria: - The standard exclusion criteria for MRI exams will apply which include patients with pacemakers, non-compatible intra-cranial vascular clips, inner ear implants, and severe claustrophobia. - Patients who because of age, general medical or psychiatric condition, or physiologic status unrelated to the presence of prostate cancer are unlikely to be candidates for repeat MRIs, or cannot give valid informed consent. - Patients unwilling or unable to undergo the multiparametric MRI exam (non-endorectal coil). - Patients with a history of allergic reaction to latex or Gadolinium containing intravenous contrast agents. - Individuals with renal disease or other contraindications to gadolinium will be excluded. The BWH standard MRI contrast screening criteria will be used to establish renal status. - Patients who have had prior prostatectomy or prior androgen therapy. - Patients with hip implant or any other metallic implant or device that results in significant distortion of the local magnetic field and compromise of the quality of the multiparametric MRI data.
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