High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB)
SIB
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
1 other identifier
interventional
80
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Jun 2010
Longer than P75 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 23, 2010
CompletedFirst Submitted
Initial submission to the registry
June 18, 2014
CompletedFirst Posted
Study publicly available on registry
June 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2030
ExpectedJuly 1, 2025
June 1, 2025
15.8 years
June 18, 2014
June 26, 2025
Conditions
Outcome Measures
Primary Outcomes (13)
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
4 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
7 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
10 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
13 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
16 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
19 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
22 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
25 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
31 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
37 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
43 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
49 months
Change from baseline PSA level
PSA level in blood is measured in units of nanograms per milliliter.
55 months
Study Arms (1)
IMRT & IGRT Radiation Therapy
EXPERIMENTALIn 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).
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 17544601BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Hall, MD
Medical College of Wisconsin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 18, 2014
First Posted
June 27, 2014
Study Start
June 23, 2010
Primary Completion
April 1, 2026
Study Completion (Estimated)
June 21, 2030
Last Updated
July 1, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share