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

December 7, 2009
May 17, 2012
June 2009
April 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01028885 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
MRI-Guided Radiation Therapy in Treating Patients Who Have Undergone Surgery to Remove the Prostate
A Prospective Study Implementing MRI Based Treatment Planning for Clinical Target Volume Definition and Immobilization in Post-Prostatectomy Radiation Treatment

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
    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
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.

Interventions:
  • Procedure: radiation therapy treatment planning/simulation
  • Procedure: intensity-modulated radiation therapy
  • Procedure: image-guided radiation therapy
  • Procedure: magnetic resonance imaging
  • Procedure: computed tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01028885
UPCC 10809, NCI-2009-01441
No
Vapiwala, Neha, Abramson Cancer Center of The University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Not Provided
Principal Investigator: Neha Vapiwala Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP