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Completed

NCT Number: NCT00214136

Intensity Modulated Radiation Therapy (IMRT) Radiotherapy for Treating Prostate Pelvic Nodes

The purpose of this study is to examine the clinical feasibility and efficacy of uing IMRT to escalate the biologically effective dose to the pelvic lymph nodes in a short course of radiation therapy. An increased total and biologically effective dose will be delivered to the pelvic lymph nodes (56 Gy at 2 Gy/fraction). The prostate will receive standard "short course" IMRT of radiation (70 Gy at 2.5 Gy/fraction).

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University Of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Radiotherapy

Radiation

prostate radiation to 70Gy; nodal radiation to 56Gy

Primary outcomes

  1. Number of Participants Experiencing Expected Toxicities

    Time frame: Up to 5 years

    Tolerances to high dose RT to Pelvic Lymph nodes in treatment of prostate cancer; measured by participants experiencing expected toxicities.

Secondary outcomes

  1. To Evaluate Local Tumor Control and Biochemical Progression-free and Metastasis-free Survival

    Time frame: 5 years

    Clinically evaluate local tumor control and biochemical progression-free and metastasis-free survivals.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2016
Study completion
2016
First posted
Sep 21, 2005
Registry last updated
Aug 4, 2021

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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