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Radiation Therapy
SBRT with Urethral-Sparing IMRT for Prostate Cancer
N/A
Waitlist Available
Led By Zachary Morris
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical stage N0, M0
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, 1 year, and 2 years
Awards & highlights
Study Summary
This trial studies the side effects and best dose of stereotactic body radiation therapy while using IMRT planning to help avoid radiation to normal tissue in patients with prostate cancer.
Who is the study for?
This trial is for men with prostate cancer confirmed by a biopsy within the last 180 days, Gleason score ≤7 without aggressive patterns, clinical stage ≤T2b, PSA ≤20 ng/ml. Participants should have good performance status (able to carry out daily activities) and no severe urinary blockage or active infections. Men who've had certain other cancers in the past 5 years or specific treatments for prostate cancer aren't eligible.Check my eligibility
What is being tested?
The trial is testing high-dose stereotactic body radiation therapy using IMRT planning to minimize damage to normal tissue in prostate cancer patients. It aims to find the best dose that's effective while sparing healthy tissue like the urethra, delivering treatment over fewer days compared to standard therapy.See study design
What are the potential side effects?
Potential side effects include skin reactions in treated areas, fatigue, urinary issues such as increased frequency and discomfort during urination, bowel changes like diarrhea or rectal bleeding, erectile dysfunction due to nerve damage around the prostate.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has not spread to lymph nodes or other parts of my body.
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I am fully active or can carry out light work.
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My prostate cancer has a Gleason score of 7 or less, with no aggressive patterns.
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My cancer is in an early stage and has not spread deeply.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, 1 year, and 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, 1 year, and 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease-free survival as measured by the Phoenix definition
Incidence of GU and GI Acute Toxicity
Incidence of GU and GI Late Toxicity
Secondary outcome measures
Change in American Urological Association Symptom Score (AUASS)
Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment
Change in International Index of Erectile Dysfunction Questionnaire (IIEF-5)
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (moderate dose SBRT with SIB)Experimental Treatment2 Interventions
Patients undergo 5 fractions of moderate dose SBRT with SIB every other day for 10 days following urethral-sparing IMRT planning.
SBRT: 8.0Gy escalated dose
Group II: Arm B (uniform dose SBRT)Active Control2 Interventions
Patients undergo 5 fractions of uniform dose SBRT every other day for 10 days following urethral-sparing IMRT planning.
SBRT: 7.5Gy conventional dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SBRT
2014
Completed Phase 2
~1060
Radiation Therapy Treatment Planning and Simulation
2014
N/A
~10
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,167,272 Total Patients Enrolled
34 Trials studying Prostate Cancer
8,966 Patients Enrolled for Prostate Cancer
Zachary MorrisPrincipal InvestigatorUniversity of Wisconsin, Madison
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have scleroderma.My prostate cancer was confirmed by a biopsy within the last 6 months.I have had a prostate exam in the last 90 days.You have a serious health condition that is currently active and may interfere with your ability to participate in the study.I had a prostate surgery less than 3 months ago.I am currently on IV antibiotics for a bacterial or fungal infection.My cancer has not spread to lymph nodes or other parts of my body.I am fully active or can carry out light work.I have been cancer-free for at least 5 years, except for non-dangerous skin cancers.I have severe problems with urination.I have had surgery or cryosurgery for prostate cancer.I have Crohn's disease or ulcerative colitis.I have undergone hormone therapy for up to a year.My prostate cancer has a Gleason score of 7 or less, with no aggressive patterns.My cancer is in an early stage and has not spread deeply.I have had radiation therapy or seed implant treatment in my pelvic area.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (uniform dose SBRT)
- Group 2: Arm A (moderate dose SBRT with SIB)
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 still opportunities to volunteer for this research endeavor?
"Based on clinicaltrials.gov, the recruitment phase for this medical trial is no longer active; it was initially posted in July 2015 and most recently updated in August 2022. There are currently 1,969 other trials actively seeking participants."
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