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

Prostate Cancer Clinical Trial

Official title:

A Prospective Study Implementing MRI Based Treatment Planning for Clinical Target Volume Definition and Immobilization in Post-Prostatectomy Radiation Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028885
• Other study ID #: UPCC 10809
• Secondary ID: NCI-2009-01441
• Status: Completed
• Phase: Phase 1
• Start date: June 2009
• Est. completion date: June 2018

Study information

• Verified date: July 2019
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00977743

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2018
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostate Cancer
• Prostatic Neoplasms
• Stage I Prostate Cancer
• Stage II Prostate Cancer
• Stage III Prostate Cancer

Intervention

Procedure:
• radiation therapy treatment planning/simulation

• intensity-modulated radiation therapy

• image-guided radiation therapy

• magnetic resonance imaging

• computed tomography

Locations

Country	Name	City	State
United States	Abramson Cancer Center of The University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical treatment target motion and deformation as quantified by co-registration of weekly MRI scans with original treatment planning MRI scans
Primary	Avoidance of any unexpected grade 3 or 4 toxicities
Secondary	Comparison of MRI and CT delineated target volumes defined during the treatment planning process
Secondary	Distributions of clinical target volume (CTV), bladder and rectum volumes, and percent change from baseline
Secondary	Incidence of CTV falling outside the planned treatment volume (PTV)
Secondary	Distributions of the proportion of the total CTV which falls outside the PTV
Secondary	Dose-volume exposures