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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

radiotherapy

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

University Of Wisconsin Hospital and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

prostate radiation to 70Gy, lymph nodes to 56Gy

Outcomes

Primary Outcome Measures

Number of Participants Experiencing Expected Toxicities

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT00214136

First Posted

September 13, 2005

Last Updated

August 2, 2021

Sponsor

University of Wisconsin, Madison

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00214136

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

March 2005 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

prostate radiation to 70Gy, lymph nodes to 56Gy

Intervention Type

Radiation

Intervention Name(s)

radiotherapy

Intervention Description

prostate radiation to 70Gy; nodal radiation to 56Gy

Primary Outcome Measure Information:

Title

Number of Participants Experiencing Expected Toxicities

Description

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

Time Frame

Up to 5 years

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

5 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Ritter, MD, PhD

Organizational Affiliation

University of Wisconsin, Madison

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Of Wisconsin Hospital and Clinics

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

12. IPD Sharing Statement

Links:

URL

https://cancer.wisc.edu/

Description

University of Wisconsin Carbone Cancer Center

Learn more about this trial

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

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