Early Changes In Multiparametric MRI In Prostate Cancer
May 22, 2020 updated by: Fiona Fennessy, Dana-Farber Cancer Institute
Early Changes in Multiparametric MRI in Response to Neoadjuvant Androgen Deprivation and External Beam Radiation Therapy for Prostate Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MRIs and 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation Between MRI Parameter at Visit 1 and Nadir PSA
Time Frame: 2 months after starting ADT (Visit 1)
|
Pearson correlation coefficient between MRI parameters at visit 1 and nadir PSA
|
2 months after starting ADT (Visit 1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation Between MRI Parameter at Visit 2 With Nadir PSA
Time Frame: 6 weeks after starting EBRT (Visit 2)
|
Pearson correlation coefficient between MRI parameters at visit 2 with nadir PSA
|
6 weeks after starting EBRT (Visit 2)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Fiona Fennessy, MD, PhD, Dana-Farber Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
October 8, 2013
First Submitted That Met QC Criteria
October 8, 2013
First Posted (Estimate)
October 10, 2013
Study Record Updates
Last Update Posted (Actual)
June 2, 2020
Last Update Submitted That Met QC Criteria
May 22, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-343
- U01CA151261 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.