Overview

This trial is active, not recruiting.

Conditions prostate cancer, adenocarcinoma of the prostate, stage i prostate cancer, stage ii prostate cancer, stage iii prostate cancer
Treatments radiation therapy treatment planning/simulation, intensity-modulated radiation therapy, image-guided radiation therapy, magnetic resonance imaging, computed tomography
Phase phase 1
Sponsor Abramson Cancer Center of the University of Pennsylvania
Start date June 2009
End date February 2012
Trial size 10 participants
Trial identifier NCT01028885, NCI-2009-01441, NCT00977743, UPCC 10809

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
radiation therapy treatment planning/simulation
intensity-modulated radiation therapy IMRT
image-guided radiation therapy
magnetic resonance imaging MRI
computed tomography tomography, computed

Primary Outcomes

Measure
Clinical treatment target motion and deformation as quantified by co-registration of weekly MRI scans with original treatment planning MRI scans
time frame:
Avoidance of any unexpected grade 3 or 4 toxicities
time frame:

Secondary Outcomes

Measure
Comparison of MRI and CT delineated target volumes defined during the treatment planning process
time frame:
Distributions of clinical target volume (CTV), bladder and rectum volumes, and percent change from baseline
time frame:
Incidence of CTV falling outside the planned treatment volume (PTV)
time frame:
Distributions of the proportion of the total CTV which falls outside the PTV
time frame:
Dose-volume exposures
time frame:

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title A Prospective Study Implementing MRI Based Treatment Planning for Clinical Target Volume Definition and Immobilization in Post-Prostatectomy Radiation Treatment
Principal investigator Neha Vapiwala
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Abramson Cancer Center of the University of Pennsylvania.