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Phase I/II Trial Examining Dose-per-Fraction Escalation Using Intensity Modulated Radiation Therapy in the Treatment of Prostate Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Phase I/II Trial Examining Dose-per-Fraction Escalation Using Intensity Modulated Radiation Therapy in the Treatment of Prostate Cancer


Inclusion Criteria:



- Prostate Cancer stage 2b or less, predicted risk of lymph node involvement less then
15%, Gleason <7, No distance mets

Exclusion Criteria:

- distant mets

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate acute and long term tolerances to dose-per-fraction escalation in the treatment of prostate cancer using optimized treatment of IMRT, daily rectal balloon displacement, and transabdominal ultrasound localization of the prostate

Outcome Time Frame:

90 days post radiation

Safety Issue:

Yes

Principal Investigator

Mark Ritter, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Food and Drug Administration

Study ID:

RO02803

NCT ID:

NCT00214097

Start Date:

August 2002

Completion Date:

December 2015

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001