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

NCT ID: NCT01028885

Last Updated: 2019-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2018-06-30

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.

Conditions

Prostate Cancer; Adenocarcinoma of the Prostate; Stage I Prostate Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

radiation therapy treatment planning/simulation

Intervention Type: PROCEDURE

intensity-modulated radiation therapy

Intervention Type: PROCEDURE

image-guided radiation therapy

Intervention Type: PROCEDURE

magnetic resonance imaging

Intervention Type: PROCEDURE

computed tomography

Intervention Type: PROCEDURE

Interventions

radiation therapy treatment planning/simulation

Intervention Type: PROCEDURE

intensity-modulated radiation therapy

Intervention Type: PROCEDURE

image-guided radiation therapy

Intervention Type: PROCEDURE

magnetic resonance imaging

Intervention Type: PROCEDURE

computed tomography

Intervention Type: PROCEDURE

Other Intervention Names

IMRT; MRI; NMR imaging; NMRI; nuclear magnetic resonance imaging; tomography, computed

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neha Vapiwala

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

NCI-2009-01441

Identifier Type: -

Identifier Source: secondary_id

UPCC 10809

Identifier Type: -

Identifier Source: org_study_id

NCT00977743

Identifier Type: -

Identifier Source: nct_alias