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Incorporating MR Imaging Into Prostate Radiotherapy Treatment Planning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02470910
Recruitment Status : Completed
First Posted : June 12, 2015
Results First Posted : November 27, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute

Brief Summary:
This research study is evaluating whether a standard prostate MRI examination can improve radiation therapy planning for prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Adenocarcinoma of the Prostate Stage I Adenocarcinoma of the Prostate Stage II Adenocarcinoma of the Prostate Stage III Device: Magnetic Resonance Imaging Not Applicable

Detailed Description:

In this research study, the investigators want to determine if prostate radiotherapy treatment planning can be improved by using an MRI scan to help doctors more accurately target the prostate with radiation and decrease radiation dose to the rectum, which is just behind the prostate.

To do this, the investigators will create a treatment plan based on the MRI scan and compare it to the standard treatment, which currently uses a CT scan rather than an MRI. The results of this study will help inform doctors whether it is beneficial to routinely use an MRI scan for prostate radiotherapy treatment planning.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Incorporating MR Imaging Into Prostate Radiotherapy Treatment Planning: A Pilot Study to Quantitate the Potential to Limit Radiation Dose to Normal Tissues.
Study Start Date : July 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Magnetic resonance imaging
MRI examination after intraprostatic fiducial markers have been placed and prior to beginning radiotherapy
Device: Magnetic Resonance Imaging
Other Name: MRI




Primary Outcome Measures :
  1. Comparison of Rectal Volume Receiving 70 Gy or More With CT Versus MRI-planned Prostate Radiotherapy. [ Time Frame: within 1 year of MRI examination ]
    The volume of rectum receiving or exceeding 70 Gy will be calculated from the dose-volume histogram. Results will be compared for CT and MRI-based plans.


Secondary Outcome Measures :
  1. Comparison of Bladder Volume Receiving 70 Gy or More With CT Versus MRI-planned Prostate Radiotherapy. [ Time Frame: within 1 year of MRI examination ]
    The volume of bladder receiving or exceeding 70 Gy will be calculated from the dose-volume histogram. Results will be compared for CT and MRI-based plans.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have histologically confirmed prostate cancer.
  • PSA level and prostate biopsy must be reviewed at Brigham and Women's Hospital or the Dana Farber Cancer Institute and should support a diagnosis of stage I-III prostate adenocarcinoma.
  • Candidates with PSA greater than 20, digital rectal exam consistent with disease outside the prostate (clinical T3/T4 disease), or Gleason score 8 or greater, should have a bone scan and diagnostic pelvic CT or MRI to exclude metastatic disease.
  • Prostate biopsy, serum PSA measurement, and any indicated diagnostic imaging studies must be performed within 60 days of the date of registration.
  • Participants should not have had prior curative local treatment for prostate cancer, including no radiotherapy or prostatectomy. A maximum 90 days of systemic androgen deprivation therapy prior to registration is allowed.
  • Participation is limited to adult patients, age 18 years or older.
  • ECOG performance status ≥2 (Karnofsky ≥60%)
  • Life expectancy of greater than 10 years.
  • Able to tolerate an MRI examination.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Participants with known or suspected metastatic (stage IV) prostate cancer.
  • Participants with an implanted device, prosthesis, or any other foreign body with ferromagnetic properties that would make them ineligible to undergo MRI examination.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470910


Locations
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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Anthony D'Amico, MD, PhD Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute:
Publications:

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Responsible Party: Anthony V. D'Amico, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02470910    
Other Study ID Numbers: 14-585
First Posted: June 12, 2015    Key Record Dates
Results First Posted: November 27, 2019
Last Update Posted: December 11, 2019
Last Verified: December 2019
Keywords provided by Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute:
Prostate Cancer
Stage I-III prostate adenocarcinoma
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type