Your session is about to expire
← Back to Search
Brachytherapy
Brachytherapy + SBRT for Prostate Cancer
N/A
Recruiting
Led By Michael J Baine, MD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 4, 10, 16, 22, and 28 post-sbrt
Awards & highlights
Study Summary
This trial tests if a type of radiation treatment can effectively treat prostate cancer with potential side effects.
Who is the study for?
Men over 19 with intermediate or high-risk prostate cancer that hasn't spread, who haven't had previous treatments, and are expected to live more than 10 years. They should have a good performance status (able to carry out daily activities), no large prostate issues, and be able to undergo anesthesia.Check my eligibility
What is being tested?
This trial tests combining Stereostatic Body Radiation Therapy (SBRT) for the whole prostate and nearby lymph nodes with High Dose Brachytherapy (HDR) directly in the prostate. It aims to assess safety and effectiveness in treating unfavorable-intermediate risk or higher localized prostate cancer.See study design
What are the potential side effects?
Potential side effects include urinary problems, bowel discomfort, fatigue, skin reactions near treatment areas, erectile dysfunction, and other radiation-related symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 4, 10, 16, 22, and 28 post-sbrt
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 4, 10, 16, 22, and 28 post-sbrt
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Treatment-Related Adverse Events
Secondary outcome measures
Biochemical progression free survival (bPFS)
Number of patients with local control (LC), locoregional control (LRC), distant metastasis (DM), and overall survival (OS)
Proportion of patients with chronic toxicity and side-effects from HDR Brachytherapy and SBRT
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: High Dose Rate (HDR) Brachytherapy and Stereoscopic Body Radiation (SBRT) treatmentExperimental Treatment2 Interventions
High dose rate Brachytherapy in combination with stereoscopic body radiation therapy.
Find a Location
Who is running the clinical trial?
University of NebraskaLead Sponsor
539 Previous Clinical Trials
1,144,681 Total Patients Enrolled
4 Trials studying Prostate Cancer
1,000,054 Patients Enrolled for Prostate Cancer
Michael J Baine, MDPrincipal InvestigatorUniversity of Nebraska
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My risk of cancer spread to lymph nodes is 15% or higher.My doctor says I cannot have radiation therapy due to certain health risks.I have had a Urolift procedure.I have been cancer-free for at least a year, except for prostate or non-melanoma skin cancer.I cannot have general anesthesia due to health reasons.I have a preexisting rectal fistula.I have not received any treatment for my condition yet.My scans show no cancer spread to lymph nodes or distant parts.I can carry out normal activities with minimal symptoms.I am 19 years old or older.I am considered suitable for a specific type of internal radiation treatment.I have had surgery on my rectum before.I have not had major surgery, open biopsy, or significant injury in the last 30 days.My prostate is large, which may affect certain medical procedures.My prostate cancer is confirmed to be at an intermediate or higher risk level.
Research Study Groups:
This trial has the following groups:- Group 1: High Dose Rate (HDR) Brachytherapy and Stereoscopic Body Radiation (SBRT) treatment
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.
How many individuals are participating in the research protocol?
"Affirmative. Clinicaltrials.gov contains information indicating that this clinical trial is actively enrolling patients; it was initiated on August 29th, 2023 and most recently updated the same day with a goal of obtaining 53 participants at one location."
Answered by AI
Are there vacancies for participants in this medical experiment?
"Yes, as per the information available on clinicaltrials.gov, this research endeavour is actively enrolling participants. It was first advertised in August of 2023 and has not been revised since then. The medical trial requires 53 patients from a single location to complete it."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger