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Early Changes In Multiparametric MRI In Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MRI

PSA Blood Test

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Brigham and Women's Hospital
Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRIs and PSA Blood Test

Arm Description

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

Outcomes

Primary Outcome Measures

Correlation Between MRI Parameter at Visit 1 and Nadir PSA

Pearson correlation coefficient between MRI parameters at visit 1 and nadir PSA

Secondary Outcome Measures

Correlation Between MRI Parameter at Visit 2 With Nadir PSA

Pearson correlation coefficient between MRI parameters at visit 2 with nadir PSA

Full Information

NCT ID

NCT01959542

First Posted

October 8, 2013

Last Updated

May 22, 2020

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01959542

Brief Title

Early Changes In Multiparametric MRI In Prostate Cancer

Official Title

Early Changes in Multiparametric MRI in Response to Neoadjuvant Androgen Deprivation and External Beam Radiation Therapy for Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Prostate Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MRIs and PSA Blood Test

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

MRI

Intervention Type

Other

Intervention Name(s)

PSA Blood Test

Intervention Description

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.

Primary Outcome Measure Information:

Title

Correlation Between MRI Parameter at Visit 1 and Nadir PSA

Description

Pearson correlation coefficient between MRI parameters at visit 1 and nadir PSA

Time Frame

2 months after starting ADT (Visit 1)

Secondary Outcome Measure Information:

Title

Correlation Between MRI Parameter at Visit 2 With Nadir PSA

Description

Pearson correlation coefficient between MRI parameters at visit 2 with nadir PSA

Time Frame

6 weeks after starting EBRT (Visit 2)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fiona Fennessy, MD, PhD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

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Early Changes In Multiparametric MRI In Prostate Cancer

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