MRI-Guided Radiation Therapy in Treating Patients Who Have Undergone Surgery to Remove the Prostate
Primary Purpose
Prostate Cancer, Adenocarcinoma of the Prostate, Stage I Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
radiation therapy treatment planning/simulation
intensity-modulated radiation therapy
image-guided radiation therapy
magnetic resonance imaging
computed tomography
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion
- Completion of a radical prostatectomy for adenocarcinoma of the prostate
- Scheduled post-operative radiation therapy as part of the patient's treatment for prostate cancer
- Subjects are capable of giving informed consent
Exclusion
- The presence of grossly visualized or palpable disease recurrence
- Patients who are unable to undergo an MRI scan such as those with an implanted permanent pacemaker or ICD
- Patients with metastatic disease or an increasing PSA
Sites / Locations
- Abramson Cancer Center of The University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm I
Arm Description
Patients undergo MRI and CT scan-based simulation for treatment planning with endorectal balloon target immobilization. The treatment target volumes and surrounding organs at risk are contoured, treatment plan developed and approved. Patients then undergo 39 fractions of image-guided intensity-modulated radiotherapy over 8 weeks. Patients also undergo weekly MRI scans of the pelvis (in the planned treatment position) during radiotherapy.
Outcomes
Primary Outcome Measures
Clinical treatment target motion and deformation as quantified by co-registration of weekly MRI scans with original treatment planning MRI scans
Avoidance of any unexpected grade 3 or 4 toxicities
Secondary Outcome Measures
Comparison of MRI and CT delineated target volumes defined during the treatment planning process
Distributions of clinical target volume (CTV), bladder and rectum volumes, and percent change from baseline
Incidence of CTV falling outside the planned treatment volume (PTV)
Distributions of the proportion of the total CTV which falls outside the PTV
Dose-volume exposures
Full Information
NCT ID
NCT01028885
First Posted
December 7, 2009
Last Updated
July 24, 2019
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01028885
Brief Title
MRI-Guided Radiation Therapy in Treating Patients Who Have Undergone Surgery to Remove the Prostate
Official Title
A Prospective Study Implementing MRI Based Treatment Planning for Clinical Target Volume Definition and Immobilization in Post-Prostatectomy Radiation Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective clinical trial examining the use of MRI to measure internal organ motion and any resulting changes in the target volume (shape and location) during a course of post-operative radiation therapy for prostate cancer. The goal is to better understand and characterize these physiologic variations so that they can be accounted for during the treatment planning process. The ultimate longer-term clinical goal here is to provide a form of adaptive radiation therapy in the future, such that if major changes are seen over an 8-week course of radiation therapy in our study. This may argue for hypofractionating those patients who are most likely to have major shifts over time.
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the use of MRI in delineating clinical target volumes, as well as endorectal balloon target immobilization in patients treated with radiation following radical prostatectomy.
SECONDARY OBJECTIVES:
II. Trends over time in CTV, bladder and rectum volumes and percent change from baseline at each time point. III. Frequency of events in which the CTV falls outside the PTV. IV. Proportion of the total CTV which falls outside the PTV at each event. V. Trends over time in dose-volume exposures for bladder and rectum.
OUTLINE: Patients undergo MRI and CT scan-based simulation for treatment planning with endorectal balloon target immobilization. The treatment target volumes and surrounding organs at risk are contoured, treatment plan developed and approved.
Patients then undergo 39 fractions of image-guided intensity-modulated radiotherapy over 8 weeks. Patients also undergo weekly MRI scans of the pelvis (in the planned treatment position) during radiotherapy.
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 Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients undergo MRI and CT scan-based simulation for treatment planning with endorectal balloon target immobilization. The treatment target volumes and surrounding organs at risk are contoured, treatment plan developed and approved.
Patients then undergo 39 fractions of image-guided intensity-modulated radiotherapy over 8 weeks. Patients also undergo weekly MRI scans of the pelvis (in the planned treatment position) during radiotherapy.
Intervention Type
Procedure
Intervention Name(s)
radiation therapy treatment planning/simulation
Intervention Type
Procedure
Intervention Name(s)
intensity-modulated radiation therapy
Other Intervention Name(s)
IMRT
Intervention Type
Procedure
Intervention Name(s)
image-guided radiation therapy
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Other Intervention Name(s)
MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Other Intervention Name(s)
tomography, computed
Primary Outcome Measure Information:
Title
Clinical treatment target motion and deformation as quantified by co-registration of weekly MRI scans with original treatment planning MRI scans
Title
Avoidance of any unexpected grade 3 or 4 toxicities
Secondary Outcome Measure Information:
Title
Comparison of MRI and CT delineated target volumes defined during the treatment planning process
Title
Distributions of clinical target volume (CTV), bladder and rectum volumes, and percent change from baseline
Title
Incidence of CTV falling outside the planned treatment volume (PTV)
Title
Distributions of the proportion of the total CTV which falls outside the PTV
Title
Dose-volume exposures
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion
Completion of a radical prostatectomy for adenocarcinoma of the prostate
Scheduled post-operative radiation therapy as part of the patient's treatment for prostate cancer
Subjects are capable of giving informed consent
Exclusion
The presence of grossly visualized or palpable disease recurrence
Patients who are unable to undergo an MRI scan such as those with an implanted permanent pacemaker or ICD
Patients with metastatic disease or an increasing PSA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neha Vapiwala
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of The University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
MRI-Guided Radiation Therapy in Treating Patients Who Have Undergone Surgery to Remove the Prostate
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