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Completed

NCT Number: NCT01028885

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

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.

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Key information

Conditions

Prostate Cancer Adenocarcinoma of the Prostate Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Stage I Prostate Cancer Stage II Prostate Cancer Stage III Prostate Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radiation therapy treatment planning/simulation

Procedure

Intensity-Modulated Radiation Therapy

Procedure

Other names: IMRT

image-guided radiation therapy

Procedure

Magnetic Resonance Imaging

Procedure

Other names: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Computed Tomography

Procedure

Other names: tomography, computed

Primary outcomes

  1. Clinical treatment target motion and deformation as quantified by co-registration of weekly MRI scans with original treatment planning MRI scans

  2. Avoidance of any unexpected grade 3 or 4 toxicities

Secondary outcomes

  1. Comparison of MRI and CT delineated target volumes defined during the treatment planning process

  2. Distributions of clinical target volume (CTV), bladder and rectum volumes, and percent change from baseline

  3. Incidence of CTV falling outside the planned treatment volume (PTV)

  4. Distributions of the proportion of the total CTV which falls outside the PTV

  5. Dose-volume exposures

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2018
First posted
Dec 9, 2009
Registry last updated
Jul 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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