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

This study has been completed.
Sponsor:
Information provided by:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01028885
First received: December 7, 2009
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Clinical treatment target motion and deformation as quantified by co-registration of weekly MRI scans with original treatment planning MRI scans [ Designated as safety issue: No ]
  • Avoidance of any unexpected grade 3 or 4 toxicities [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comparison of MRI and CT delineated target volumes defined during the treatment planning process [ Designated as safety issue: No ]
  • Distributions of clinical target volume (CTV), bladder and rectum volumes, and percent change from baseline [ Designated as safety issue: No ]
  • Incidence of CTV falling outside the planned treatment volume (PTV) [ Designated as safety issue: No ]
  • Distributions of the proportion of the total CTV which falls outside the PTV [ Designated as safety issue: No ]
  • Dose-volume exposures [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: June 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: IMRT
Procedure: image-guided radiation therapy Procedure: magnetic resonance imaging
Other Names:
  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging
Procedure: computed tomography
Other Name: tomography, computed

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028885

Locations
United States, Pennsylvania
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
  More Information

No publications provided

Responsible Party: Vapiwala, Neha, Abramson Cancer Center of The University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01028885     History of Changes
Obsolete Identifiers: NCT00977743
Other Study ID Numbers: UPCC 10809, NCI-2009-01441
Study First Received: December 7, 2009
Last Updated: May 17, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 22, 2014