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


Phase 1
18 Years
N/A
Not Enrolling
Male
Prostate Cancer, Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Neha Vapiwala

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Institutional Review Board

Study ID:

UPCC 10809

NCT ID:

NCT01028885

Start Date:

June 2009

Completion Date:

April 2012

Related Keywords:

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

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283