Intensity Modulated Radiation Therapy (IMRT) Radiotherapy for Treating Prostate Pelvic Nodes
A Phase II Prostate Cancer Trial Treating Pelvic Lymph Nodes to High Dose Using Intensity Modulated Radiation Therapy
6 other identifiers
interventional
30
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 prostate-cancer
Started Mar 2005
Longer than P75 for phase_2 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedResults Posted
Study results publicly available
October 12, 2017
CompletedAugust 4, 2021
August 1, 2021
11 years
September 13, 2005
August 8, 2017
August 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to 5 years
Secondary Outcomes (1)
To Evaluate Local Tumor Control and Biochemical Progression-free and Metastasis-free Survival
5 years
Study Arms (1)
1
EXPERIMENTALprostate radiation to 70Gy, lymph nodes to 56Gy
Interventions
Eligibility Criteria
You may qualify if:
- Prostate cancer stage T-T3
- Predicted risk of lymph node involvement \> 15%
- Gleason \> 7
You may not qualify if:
- Distance metastases
- Use of anti-coagulant therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University Of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Mark A. Ritter
- Organization
- University of Wisconsin Carbone Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Ritter, MD, PhD
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
March 1, 2005
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
August 4, 2021
Results First Posted
October 12, 2017
Record last verified: 2021-08