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Brachytherapy

Combined Radiation Therapy for Prostate Cancer

Phase 1
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
Must not have
History of prior pelvic irradiation
Documented distant metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had radiation therapy to my pelvic area before.
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My cancer has spread to distant parts of my body.
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I have had surgery or cryosurgery for prostate cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose limiting toxicities (DLT) graded according to the National Cancer Institute, Common Toxicity Criteria (NCI, CTC), v 4.0
Secondary study objectives
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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
Brachytherapy
2007
Completed Phase 3
~2140
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790
Quality-of-life assessment
2015
Completed Phase 2
~650

Find a Location

Who is running the clinical trial?

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
163 Previous Clinical Trials
10,803 Total Patients Enrolled
10 Trials studying Prostate Cancer
1,383 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

High-Dose Rate Brachytherapy (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01655836 — Phase 1
Prostate Cancer Research Study Groups: Treatment (HDR brachytherapy, SBRT)
Prostate Cancer Clinical Trial 2023: High-Dose Rate Brachytherapy Highlights & Side Effects. Trial Name: NCT01655836 — Phase 1
High-Dose Rate Brachytherapy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01655836 — Phase 1
~3 spots leftby Dec 2025
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