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Brachytherapy
Combined Radiation Therapy for Prostate Cancer
N/A
Waitlist Available
Led By Robert Den, MD
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adenocarcinoma of the prostate with intermediate risk disease T2b-T2c or Gleason score 7 or prostate specific antigen (PSA) 10-20 ng/ml, without metastatic disease
Karnofsky performance status > 70
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment that combines two different types of radiation therapy. The first part of the treatment involves placing radioactive material inside the patient's body for a short time. The second part of the treatment uses a new type of radiation therapy that delivers very high doses of radiation to tumors with high precision. The purpose of the trial is to determine if this new treatment is safe.
Who is the study for?
Men over 18 with intermediate-risk prostate cancer (specific criteria like T2b-T2c, Gleason score of 7, or PSA levels of 10-20 ng/ml) without metastatic disease can join. They must have certain blood cell counts, agree to use contraception for three months post-treatment, and not have had previous pelvic radiation or surgeries that could complicate treatment.Check my eligibility
What is being tested?
The trial is testing the safety of combining two types of radiation therapy: high-dose rate brachytherapy (internal radiation) and stereotactic body radiation therapy (SBRT), which delivers precise doses in a short period. The goal is to see if this combination effectively treats prostate cancer.See study design
What are the potential side effects?
Possible side effects include irritation at the site where radioactive material is placed for brachytherapy, fatigue from SBRT treatments, skin reactions similar to sunburns, urinary issues such as frequency or discomfort, bowel changes like diarrhea or rectal bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is at an intermediate stage, without spread to other parts.
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I am able to care for myself and perform normal activities with minimal assistance.
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I am older than 18 years.
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I have never had radiation therapy to my pelvic area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicities (DLT) graded according to the National Cancer Institute, Common Toxicity Criteria (NCI, CTC), v 4.0
Secondary outcome measures
Acute and late hematologic toxicity profile of HDR and SBRT combination
Correlation of dosimetric parameters, including dose-volume factors for bladder and rectum, with acute toxicity
Late nonhematologic toxicity profile
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (HDR brachytherapy, SBRT)Experimental Treatment4 Interventions
Patients undergo HDR brachytherapy on day 0 followed by SBRT on days 15-30
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quality-of-life assessment
2015
Completed Phase 2
~650
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Brachytherapy
2007
Completed Phase 3
~2100
Find a Location
Who is running the clinical trial?
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
10,869 Total Patients Enrolled
12 Trials studying Prostate Cancer
1,525 Patients Enrolled for Prostate Cancer
Robert Den, MDPrincipal InvestigatorThomas Jefferson University
3 Previous Clinical Trials
68 Total Patients Enrolled
1 Trials studying Prostate Cancer
20 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had a bone scan and CT scan of my abdomen/pelvis in the last 60 days.I have had surgery on my urinary system that might complicate radiation treatment.My cancer has spread to distant parts of my body.I have had surgery or cryosurgery for prostate cancer.My prostate cancer is at an intermediate stage, without spread to other parts.I am able to care for myself and perform normal activities with minimal assistance.I am older than 18 years.I have had radiation therapy to my pelvic area before.I have never had radiation therapy to my pelvic area.I agree to use effective birth control during and for 3 months after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (HDR brachytherapy, SBRT)
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.
Has the FDA sanctioned Stereotactic Body Radiation Therapy?
"Based on the limited data currently collected, our team has assigned Stereotactic Body Radiation Therapy a score of 1 for safety."
Answered by AI
Are there any current openings for participation in this clinical trial?
"As indicated on clinicaltrials.gov, this particular study has closed recruitment, having last been updated in April of 2022 and originally posted in October 2012. Nonetheless, 1,326 other trials are accepting patients at the present moment."
Answered by AI
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