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

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Completed
CT.gov ID
NCT00214136
Collaborator
National Cancer Institute (NCI) (NIH)
30
1
1
132
0.2

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Radiation: radiotherapy
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Prostate Cancer Trial Treating Pelvic Lymph Nodes to High Dose Using Intensity Modulated Radiation Therapy
Study Start Date :
Mar 1, 2005
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

prostate radiation to 70Gy, lymph nodes to 56Gy

Radiation: radiotherapy
prostate radiation to 70Gy; nodal radiation to 56Gy

Outcome Measures

Primary Outcome Measures

  1. Number of Participants Experiencing Expected Toxicities [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 Outcome Measures

  1. To Evaluate Local Tumor Control and Biochemical Progression-free and Metastasis-free Survival [5 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792

Sponsors and Collaborators

  • University of Wisconsin, Madison
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Mark Ritter, MD, PhD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214136
Other Study ID Numbers:
  • RO04807
  • P01CA088960
  • H-2004-0472
  • NCI-2011-00947
  • A533300
  • SMPH\HUMAN ONCOLOGY
First Posted:
Sep 21, 2005
Last Update Posted:
Aug 4, 2021
Last Verified:
Aug 1, 2021
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details This study enrolled patients with high-risk prostate adenocarcinoma or radiographic evidence of pelvic lymph node involvement but absence of distal metastases from the Midwest. The last patient completed in February 2016.
Pre-assignment Detail All participants are assigned to the experimental arm.
Arm/Group Title Experimental
Arm/Group Description Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy
Period Title: Overall Study
STARTED 30
COMPLETED 25
NOT COMPLETED 5

Baseline Characteristics

Arm/Group Title Experimental
Arm/Group Description Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy
Overall Participants 30
Age (Count of Participants)
<=18 years
0
0%
Between 18 and 65 years
10
33.3%
>=65 years
20
66.7%
Sex: Female, Male (Count of Participants)
Female
0
0%
Male
30
100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
Not Hispanic or Latino
30
100%
Unknown or Not Reported
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
0
0%
White
30
100%
More than one race
0
0%
Unknown or Not Reported
0
0%
Region of Enrollment (participants) [Number]
United States
30
100%
T stage (Count of Participants)
T1c
9
30%
T2a
3
10%
T2b,c
7
23.3%
T3a,b
5
16.7%
T4
1
3.3%
Not reported
5
16.7%

Outcome Measures

1. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
Only 25 of 30 participants met the minimum follow up thresholds at the time of analysis; the 5 most recently accrued participants' data was not analyzed and is not reflected.
Arm/Group Title Experimental
Arm/Group Description Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy
Measure Participants 25
Count of Participants [Participants]
13
43.3%
2. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
Data was not collected for this outcome measure. Results can not be reported or analyzed.
Arm/Group Title Experimental
Arm/Group Description Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy
Measure Participants 0

Adverse Events

Time Frame Participants were followed up 1 month upon completion, every 3 months for 1 year after treatment, every 4 months during Years 2 and 3, every 6 months during Years 4 and 5, and then annually, with median follow up time as 25.4 months (range, 4.2 - 57.2 months). Bone scans and CT during follow-ups were not routinely performed but were carried out in the context of rising PSA levels. Of 30 participants, only 25 met the minimum follow up thresholds at the time of analysis.
Adverse Event Reporting Description Toxicity grading is based on a modified RTOG acute/late toxicity grading criteria. Serious adverse events are defined as all Grade 4 and Grade 5 toxicities. Acute toxicities are scored from the start of radiation to 90 days after completion of radiation. Late toxicities are scored > 90 days from the completion of radiation therapy for 5 years.
Arm/Group Title Experimental
Arm/Group Description Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy
All Cause Mortality
Experimental
Affected / at Risk (%) # Events
Total 6/25 (24%)
Serious Adverse Events
Experimental
Affected / at Risk (%) # Events
Total 0/25 (0%)
Other (Not Including Serious) Adverse Events
Experimental
Affected / at Risk (%) # Events
Total 13/25 (52%)
Gastrointestinal disorders
Acute GI Grade 1 13/25 (52%)
Acute GI Grade 2 8/25 (32%)
Late GI Grade 1 5/25 (20%)
Late GI Grade 2 2/25 (8%)
Renal and urinary disorders
Acute GU Grade 1 13/25 (52%)
Acute GU Grade 2 10/25 (40%)
Late GU Grade 1 9/25 (36%)
Late GU Grade 2 5/25 (20%)
Late GU Grade 3 1/25 (4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Mark A. Ritter
Organization University of Wisconsin Carbone Cancer Center
Phone 608-263-8500
Email ritter@humonc.wisc.edu
Responsible Party:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214136
Other Study ID Numbers:
  • RO04807
  • P01CA088960
  • H-2004-0472
  • NCI-2011-00947
  • A533300
  • SMPH\HUMAN ONCOLOGY
First Posted:
Sep 21, 2005
Last Update Posted:
Aug 4, 2021
Last Verified:
Aug 1, 2021