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Early Changes In Multiparametric MRI In Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01959542
Recruitment Status : Completed
First Posted : October 10, 2013
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Fiona Fennessy, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE October 8, 2013
First Posted Date  ICMJE October 10, 2013
Last Update Posted Date July 24, 2018
Study Start Date  ICMJE December 2013
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2013)
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 ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01959542 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2013)
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 ]
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Changes In Multiparametric MRI In Prostate Cancer
Official Title  ICMJE Early Changes in Multiparametric MRI in Response to Neoadjuvant Androgen Deprivation and External Beam Radiation Therapy for Prostate Cancer
Brief Summary 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.
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 starting ADT): 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • 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.
  • Other: Androgen Deprivation Therapy (ADT)
    Patients will receive ADT as part of their standard clinical care, as determined by their clinician.
  • Radiation: External Beam Radiation Therapy (EBRT)
    Patients will receive EBRT as part of their standard clinical care, as determined by their clinician.
Study Arms  ICMJE 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 starting ADT): PSA blood test and prostate MRI
Interventions:
  • Device: MRI
  • Other: PSA Blood Test
  • Other: Androgen Deprivation Therapy (ADT)
  • Radiation: External Beam Radiation Therapy (EBRT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2017)
15
Original Estimated Enrollment  ICMJE
 (submitted: October 8, 2013)
30
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01959542
Other Study ID Numbers  ICMJE 13-343
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fiona Fennessy, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Fiona Fennessy, MD, PhD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP