Early Changes In Multiparametric MRI In Prostate Cancer

NCT ID: NCT01959542

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2017-06-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

MRI

Intervention Type: DEVICE

PSA Blood Test

Intervention Type: OTHER

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.

Interventions

MRI

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Fiona Fennessy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fiona Fennessy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

U01CA151261

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-343

Identifier Type: -

Identifier Source: org_study_id