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A Phase II Prostate Cancer Trial Treating Pelvic Lymph Nodes to High Dose Using Intensity Modulated Radiation Therapy


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

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Trial Information

A Phase II Prostate Cancer Trial Treating Pelvic Lymph Nodes to High Dose Using Intensity Modulated Radiation Therapy


Inclusion Criteria:



- Prostate cancer stage T-T3

- Predicted risk of lymph node involvement > 15%

- Gleason > 7

Exclusion Criteria:

- Distance metastases

- Use of anti-coagulant therapy

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 high dose RT to Pelvic Lymph nodes in treatment of prostate cancer

Outcome Time Frame:

5years

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:

RO04807

NCT ID:

NCT00214136

Start Date:

March 2005

Completion Date:

January 2015

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001