Early Changes in Multiparametric MRI in Response to Neoadjuvant Androgen Deprivation and External Beam Radiation Therapy for Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01959542

Sponsor: Dana-Farber Cancer Institute

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Adult males with unfavorable intermediate- to high-risk localized disease, defined as having one of the following three categories, Clinical or radiographic T2b-T4 primary tumor or Gleason score 7-10 in any core, or 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:

  • 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.

View trial on ClinicalTrials.gov