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The Prostate Immobilization Device Study


N/A
18 Years
N/A
Open (Enrolling)
Male
Adenocarcinoma of the Prostate

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Trial Information

The Prostate Immobilization Device Study


Inclusion Criteria:



- 18 years of age or older

- Clinically localized T1-3 N0-1 M0 adenocarcinoma of the prostate

- Planned definitive radiation therapy

Exclusion Criteria:

- Prior proctectomy

- Rectal surgery within one year

- Proctitis

- Rectal carcinoma

- Anal Stenosis

- History of inflammatory bowel disease

- Scleroderma

- Systemic sclerosis

- Refusal of treatment with immobilization device

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Deviation of the prostate rectal interface from its position at time of simulation.

Outcome Time Frame:

Measurments will be taken for at least 5 points on a weekly basis during each course of treatment. Data will be presented for the duration of a course of radiation therapy, up to nine weeks.

Safety Issue:

No

Principal Investigator

James H Taylor, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wheaton Franciscan Cancer Care - All Saints

Authority:

United States: Institutional Review Board

Study ID:

11-019-ASH

NCT ID:

NCT01408706

Start Date:

August 2011

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location

Wheaton Francsican Cancer Care - All SaintsRacine, Wisconsin  53405