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Incorporating MR Imaging Into Prostate Radiotherapy Treatment Planning

Primary Purpose

Prostate Cancer, Adenocarcinoma of the Prostate Stage I, Adenocarcinoma of the Prostate Stage II

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnetic Resonance Imaging
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, Stage I-III prostate adenocarcinoma

Eligibility Criteria

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

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.

Sites / Locations

  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Magnetic resonance imaging

Arm Description

MRI examination after intraprostatic fiducial markers have been placed and prior to beginning radiotherapy

Outcomes

Primary Outcome Measures

Comparison of Rectal Volume Receiving 70 Gy or More With CT Versus MRI-planned Prostate Radiotherapy.
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

Comparison of Bladder Volume Receiving 70 Gy or More With CT Versus MRI-planned Prostate Radiotherapy.
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.

Full Information

First Posted
June 10, 2015
Last Updated
December 2, 2019
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02470910
Brief Title
Incorporating MR Imaging Into Prostate Radiotherapy Treatment Planning
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 Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Adenocarcinoma of the Prostate Stage I, Adenocarcinoma of the Prostate Stage II, Adenocarcinoma of the Prostate Stage III
Keywords
Prostate Cancer, Stage I-III prostate adenocarcinoma

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
Magnetic resonance imaging
Arm Type
Experimental
Arm Description
MRI examination after intraprostatic fiducial markers have been placed and prior to beginning radiotherapy
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
Comparison of Rectal Volume Receiving 70 Gy or More With CT Versus MRI-planned Prostate Radiotherapy.
Description
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.
Time Frame
within 1 year of MRI examination
Secondary Outcome Measure Information:
Title
Comparison of Bladder Volume Receiving 70 Gy or More With CT Versus MRI-planned Prostate Radiotherapy.
Description
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.
Time Frame
within 1 year of MRI examination

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony D'Amico, MD, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20493642
Citation
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PubMed Identifier
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Citation
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PubMed Identifier
10571190
Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Results Reference
derived

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Incorporating MR Imaging Into Prostate Radiotherapy Treatment Planning

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