MRI-Guided Radiation Therapy in Treating Patients Who Have Undergone Surgery to Remove the Prostate

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT01028885
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 108
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Adenocarcinoma of the Prostate; Stage I Prostate Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer	Procedure: radiation therapy treatment planning/simulation; Procedure: intensity-modulated radiation therapy; Procedure: image-guided radiation therapy; Procedure: magnetic resonance imaging; Procedure: computed tomography	Phase 1

Detailed Description

PRIMARY OBJECTIVES:

1. 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:

1. 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Study Implementing MRI Based Treatment Planning for Clinical Target Volume Definition and Immobilization in Post-Prostatectomy Radiation Treatment
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Arm I 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.

Procedure: radiation therapy treatment planning/simulation; Procedure: intensity-modulated radiation therapy; Other Names: IMRT ; Procedure: image-guided radiation therapy; Procedure: magnetic resonance imaging; Other Names: MRI NMR imaging NMRI nuclear magnetic resonance imaging ; Procedure: computed tomography; Other Names: tomography, computed

Outcome Measures

Primary Outcome Measures

1. Clinical treatment target motion and deformation as quantified by co-registration of weekly MRI scans with original treatment planning MRI scans []

2. Avoidance of any unexpected grade 3 or 4 toxicities []

Secondary Outcome Measures

1. Comparison of MRI and CT delineated target volumes defined during the treatment planning process []

2. Distributions of clinical target volume (CTV), bladder and rectum volumes, and percent change from baseline []

3. Incidence of CTV falling outside the planned treatment volume (PTV) []

4. Distributions of the proportion of the total CTV which falls outside the PTV []

5. Dose-volume exposures []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of The University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

• Principal Investigator: Neha Vapiwala, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01028885
• Other Study ID Numbers: UPCC 10809; NCI-2009-01441; NCT00977743
• First Posted: Dec 9, 2009
• Last Update Posted: Jul 25, 2019
• Last Verified: Jul 1, 2019

• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Jul 25, 2019