High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB) (SIB)
Primary Purpose
Prostate Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed, adenocarcinoma of the prostate
- T1-2N0M0 with risk of pelvic lymph nodes involvement >25% by Roach formula [(2/3xPSA) + (Gleason Score - 6)x10], or any T3-4N0M0
- Karnofsky Performance Scale > 70.
- Prostate tumor biopsy grading by Gleason score classification is mandatory prior to registration.
- No prior pelvic or prostate radiation or chemotherapy for any reason; induction hormonal therapy prior to registration is acceptable.
- Patients must sign a study-specific consent form prior to registration.
- No evidence of distant metastases (Bone scanning)
Exclusion Criteria:
- Clinical or pathological evidence of distant metastases (M1).
- Radical surgery for carcinoma of the prostate
- History of prior chemotherapy
- History of prior pelvic radiation therapy
- Children (age < 18).
Sites / Locations
- Froedtert Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IMRT & IGRT Radiation Therapy
Arm Description
In this study we will deliver a high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy).
Outcomes
Primary Outcome Measures
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
Secondary Outcome Measures
Full Information
NCT ID
NCT02177292
First Posted
June 18, 2014
Last Updated
October 5, 2023
Sponsor
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT02177292
Brief Title
High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB)
Acronym
SIB
Official Title
A Phase II Trial of High-Dose Pelvic Lymph Node IMRT( Intensity Modulated Radiation Therapy) and Hypofractionated Prostate IMRT for High Risk Prostate Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 23, 2010 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to find out the effects (good and bad) of using newer technologies that allow very precise delivery of radiation. These newer technologies are Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).
Detailed Description
In this study the treating physicians will deliver a high dose of radiation to pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy). The study will evaluate the response of the cancer and side effects of radiation to pelvic lymph nodes and to the prostate.
It is hoped that these newer technologies will:
allow a higher daily dose of radiation to the tumor and pelvic nodes
avoid nearby normal tissue and organs like the rectum and bladder
prevent the cancer from spreading or coming back
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
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMRT & IGRT Radiation Therapy
Arm Type
Experimental
Arm Description
In this study we will deliver a high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy).
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).
Intervention Description
A high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy).
Primary Outcome Measure Information:
Title
Change from baseline PSA level
Description
PSA level in blood is measured in units of nanograms per milliliter.
Time Frame
4 months
Title
Change from baseline PSA level
Description
PSA level in blood is measured in units of nanograms per milliliter.
Time Frame
7 months
Title
Change from baseline PSA level
Description
PSA level in blood is measured in units of nanograms per milliliter.
Time Frame
10 months
Title
Change from baseline PSA level
Description
PSA level in blood is measured in units of nanograms per milliliter.
Time Frame
13 months
Title
Change from baseline PSA level
Description
PSA level in blood is measured in units of nanograms per milliliter.
Time Frame
16 months
Title
Change from baseline PSA level
Description
PSA level in blood is measured in units of nanograms per milliliter.
Time Frame
19 months
Title
Change from baseline PSA level
Description
PSA level in blood is measured in units of nanograms per milliliter.
Time Frame
22 months
Title
Change from baseline PSA level
Description
PSA level in blood is measured in units of nanograms per milliliter.
Time Frame
25 months
Title
Change from baseline PSA level
Description
PSA level in blood is measured in units of nanograms per milliliter.
Time Frame
31 months
Title
Change from baseline PSA level
Description
PSA level in blood is measured in units of nanograms per milliliter.
Time Frame
37 months
Title
Change from baseline PSA level
Description
PSA level in blood is measured in units of nanograms per milliliter.
Time Frame
43 months
Title
Change from baseline PSA level
Description
PSA level in blood is measured in units of nanograms per milliliter.
Time Frame
49 months
Title
Change from baseline PSA level
Description
PSA level in blood is measured in units of nanograms per milliliter.
Time Frame
55 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed, adenocarcinoma of the prostate
T1-2N0M0 with risk of pelvic lymph nodes involvement >25% by Roach formula [(2/3xPSA) + (Gleason Score - 6)x10], or any T3-4N0M0
Karnofsky Performance Scale > 70.
Prostate tumor biopsy grading by Gleason score classification is mandatory prior to registration.
No prior pelvic or prostate radiation or chemotherapy for any reason; induction hormonal therapy prior to registration is acceptable.
Patients must sign a study-specific consent form prior to registration.
No evidence of distant metastases (Bone scanning)
Exclusion Criteria:
Clinical or pathological evidence of distant metastases (M1).
Radical surgery for carcinoma of the prostate
History of prior chemotherapy
History of prior pelvic radiation therapy
Children (age < 18).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen A Lawton, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17544601
Citation
Kupelian PA, Willoughby TR, Reddy CA, Klein EA, Mahadevan A. Hypofractionated intensity-modulated radiotherapy (70 Gy at 2.5 Gy per fraction) for localized prostate cancer: Cleveland Clinic experience. Int J Radiat Oncol Biol Phys. 2007 Aug 1;68(5):1424-30. doi: 10.1016/j.ijrobp.2007.01.067. Epub 2007 Jun 4.
Results Reference
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High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB)
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