Early Changes In Multiparametric MRI In Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Dana-Farber Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fiona Fennessy, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01959542
First received: October 8, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Prostate Cancer
Device: MRI
Other: PSA Blood Test

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Early Changes in Multiparametric MRI in Response to Neoadjuvant Androgen Deprivation and External Beam Radiation Therapy for Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • The primary aim of this study is to explore the feasibility of mpMR as an early imaging biomarker to assess response of intermediate- and high-risk prostate cancer during treatment with neoadjuvant ADT [ Time Frame: 2 month ] [ Designated as safety issue: No ]
    The primary endpoint of this study is whether mpMR parameters measured after 2 months of neoadjuvant ADT therapy (TP1) correlate with nadir PSA post 8-weeks of ADT. In addition, we will determine whether mpMR parameters in areas of tumor (T) in those who fail neoadjuvant ADT (defined as PSA end ADT values >.3 ng/ml) are different to those who respond to ADT (defined as PSA end ADT ≤.3ng/ml)


Secondary Outcome Measures:
  • A secondary aim is to explore the feasibility of mpMR as an imaging biomarker to assess response of bulky localized prostate cancer to combined ADT/EBRT. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    A secondary endpoint of this study is whether mpMR parameters measured after 6 weeks of EBRT (TP2) and 8 weeks after completion of EBRT (TP3) correlate with end PSA (defined as PSA level immediately after EBRT treatment). In addition, we will determine whether mpMR parameters in areas of T in those likely to fail combined ADT/EBRT (defined as PSA end values >.5ng/ml) are different to those of responders (PSA end values ≤.5ng/ml).


Estimated Enrollment: 30
Study Start Date: December 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRIs and PSA Blood Test
  • Visit 1 (8 weeks after starting ADT): PSA blood test and prostate MRI
  • Visit 2 (6 weeks after starting EBRT): PSA blood test and prostate MRI
  • Visit 3 (on last day of EBRT): PSA blood test
  • Visit 4 (6 months after finishing EBRT): PSA blood test and prostate MRI
Device: MRI Other: PSA Blood Test
Serum PSA will also be subsequently checked on the same day as each follow-up MR is performed, i.e. TP 1, 2 and 3, and right after finishing EBRT. 1-2 mls of blood will be sampled per blood test.

Detailed Description:

If the participant chooses to take part in this research study, the participant will have 3 follow up prostate MRIs during a 6 month time period, while the participant is having their ADT/EBRT treatment. These follow-up prostate MRIs will use a standard imaging protocol without the use of an endorectal coil. The participant will also have a total of 4 blood samples to measure serum PSA. 1-2 mls (just less than ½ teaspoon) will be taken for each sample.

Research Study Plan

  • Baseline Visit (routine standard of care screening visit): PSA blood test and prostate MRI
  • Visit 1 (8 weeks after starting ADT): PSA blood test and prostate MRI
  • Visit 2 (6 weeks after starting EBRT): PSA blood test and prostate MRI
  • Visit 3 (on last day of EBRT): PSA blood test
  • Visit 4 (6 months after finishing EBRT): PSA blood test and prostate MRI

Planned Follow-up: The investigator would like to keep track of the participant's prostate cancer status while they continue to see their doctor at DFCI. The investigators would like to do this by collecting the following data from the participant's medical records, to look at long-term outcome of their ADT/EBRT treatment.

  • PSA values
  • Clinical results of your treatment. The investigator will not contact the participant to obtain this information.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01959542

Contacts
Contact: Fiona Fennessy, MD, PhD (617) 632-4785 FFENNESSY@PARTNERS.ORG
Contact: Louise Greenberg, M.eD (617) 755 6158 LGREENBERG@PARTNERS.ORG

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Fiona Fennessy, MD, Ph.D    617-632-4785    FFENNESSY@PARTNERS.ORG   
Principal Investigator: Fiona Fennessy, MD, Ph.D         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Fiona Fennessy, MD, PhD    617-632-4785    FFENNESSY@PARTNERS.ORG   
Principal Investigator: Fiona Fennessy, MD, Ph.D         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Fiona Fennessy, MD, PhD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Fiona Fennessy, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01959542     History of Changes
Other Study ID Numbers: 13-343
Study First Received: October 8, 2013
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Prostate Cancer

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

ClinicalTrials.gov processed this record on July 24, 2014