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Radiation Therapy
Intensity Modulated Radiation Therapy for Prostate Cancer (SIB Trial)
N/A
Waitlist Available
Led By Colleen A Lawton, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 55 months
Awards & highlights
SIB Trial Summary
This trial is testing if newer, more precise radiation treatments are effective and safe.
Who is the study for?
This trial is for men with prostate cancer that hasn't spread to other parts of the body. They must have a specific Gleason score, which measures cancer aggressiveness, and no history of chemotherapy or radiation in the pelvic area. Participants need to be able to perform daily activities without significant assistance (Karnofsky Performance Scale > 70).Check my eligibility
What is being tested?
The study tests high-dose radiation therapy targeting lymph nodes using advanced technologies called Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT), aiming for precise delivery to improve treatment outcomes.See study design
What are the potential side effects?
Potential side effects include skin changes in treated areas, fatigue, urinary issues like increased frequency or discomfort, bowel changes such as diarrhea or rectal bleeding, and erectile dysfunction.
SIB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is at an early stage but has a high risk of spreading, or it's more advanced but hasn't spread to other parts.
Select...
I am able to care for myself and perform normal activities with minimal assistance.
Select...
My prostate cancer has been graded with a Gleason score.
Select...
My prostate cancer is confirmed by a biopsy.
SIB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 55 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~55 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline PSA level
Secondary outcome measures
PSA level
SIB Trial Design
1Treatment groups
Experimental Treatment
Group I: IMRT & IGRT Radiation TherapyExperimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,503 Total Patients Enrolled
7 Trials studying Prostate Cancer
8,359 Patients Enrolled for Prostate Cancer
Colleen A Lawton, MDPrincipal InvestigatorMedical College of Wisconsin
William Hall, MDPrincipal InvestigatorMedical College of Wisconsin
3 Previous Clinical Trials
419 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation therapy in the pelvic area before.My prostate cancer is at an early stage but has a high risk of spreading, or it's more advanced but hasn't spread to other parts.I haven't had radiation or chemotherapy for my pelvic or prostate area, but I may have had hormone therapy.My cancer has spread to distant parts of my body.I have had chemotherapy in the past.I am under 18 years old.I am able to care for myself and perform normal activities with minimal assistance.I have had major surgery for prostate cancer.My prostate cancer has been graded with a Gleason score.My prostate cancer is confirmed by a biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: IMRT & IGRT Radiation Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there open slots for patients to join this scientific experiment?
"The trial, which was initially listed on June 23rd 2010 and last updated on September 27th 2022 is not presently taking in participants. However, there are over 1300 other clinical trials actively recruiting patients at the present moment."
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