Early Changes In Multiparametric MRI In Prostate Cancer

NCT01959542 | Completed Results DMC

• 2 other identifiers: 13-343U01CA151261
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Correlation Between MRI Parameter at Visit 1 and Nadir PSA

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

  2 months after starting ADT (Visit 1)

Secondary Outcomes (1)

• Correlation Between MRI Parameter at Visit 2 With Nadir PSA

  6 weeks after starting EBRT (Visit 2)

Study Arms (1)

MRIs and PSA Blood Test

EXPERIMENTAL

* 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

Device: MRI; Other: PSA Blood Test

Interventions

MRI DEVICE

MRIs and PSA Blood Test

PSA Blood Test 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.

MRIs and PSA Blood Test

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Fiona Fennessy
• Organization: Brigham and Women's Hospital/Dana-farber Cancer Institute

ffennessy@bwh.harvard.edu

617 632 4891

Study Officials

• Fiona Fennessy, MD, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 10, 2013
• Study Start: December 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 2, 2020
• Results First Posted: May 4, 2020

Record last verified: 2020-05

Locations

US (2)