Intensity Modulated Radiation Therapy (IMRT) Radiotherapy for Treating Prostate Pelvic Nodes
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 |
---|---|---|
|
Phase 2 |
Study Design
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
- 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
- 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
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.- RO04807
- P01CA088960
- H-2004-0472
- NCI-2011-00947
- A533300
- SMPH\HUMAN ONCOLOGY
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
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%
|
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
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 |
ritter@humonc.wisc.edu |
- RO04807
- P01CA088960
- H-2004-0472
- NCI-2011-00947
- A533300
- SMPH\HUMAN ONCOLOGY