- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01959542
Early Changes In Multiparametric MRI In Prostate Cancer
Early Changes in Multiparametric MRI in Response to Neoadjuvant Androgen Deprivation and External Beam Radiation Therapy for Prostate Cancer
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Fiona Fennessy, MD, PhD, Dana-Farber Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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.
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