Early Changes In Multiparametric MRI In Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Device: MRI; Other: PSA Blood Test

• Registration Number: NCT01959542
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-10
• Study Start: 2013-12
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Disposition First Submitted: 2018-06-29
• Disposition First Submitted QC: 2018-07-11
• Disposition First Posted: 2018-07-12
• Results First Submitted: 2019-02-06
• Results First Submitted QC: 2020-04-22
• Status Verified: 2020-05
• Results First Posted: 2020-05-04
• Last Update Submitted: 2020-05-22
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRIs and PSA Blood Test	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
MRIs and PSA Blood Test	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

Primary Outcome Measures

Name	Time	Method
Correlation Between MRI Parameter at Visit 1 and Nadir PSA	2 months after starting ADT (Visit 1)	Pearson correlation coefficient between MRI parameters at visit 1 and nadir PSA

Secondary Outcome Measures

Name	Time	Method
Correlation Between MRI Parameter at Visit 2 With Nadir PSA	6 weeks after starting EBRT (Visit 2)	Pearson correlation coefficient between MRI parameters at visit 2 with nadir PSA

Trial Locations

Locations (2)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States