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Brachytherapy
HDR Brachytherapy for Prostate Cancer
Phase 1 & 2
Recruiting
Led By Hiram A Gay, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed diagnosis of early stage prostate cancer
Must be considered either low-risk (T1-T2a, Gleason ≤ 6, PSA < 10 ng/mL) or favorable intermediate-risk (Gleason 3 +4 = 7, percentage of positive biopsy cores < 50%, no more than one NCCN intermediate risk factor)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 3 months after completion of implant for all patients enrolled (estimated to be 5 years and 3 months)
Awards & highlights
Study Summary
This trial is testing the effects of high dose rate brachytherapy on early stage prostate cancer.
Who is the study for?
Men at least 18 years old with early stage prostate cancer, either low-risk or favorable intermediate-risk, may join this trial. They can have had hormone therapy within the last 6 months. Participants must be able to perform daily activities with minimal assistance and sign a consent form. Men who've had certain prior treatments or have serious health issues like heart disease, large TURP defects, or other recent cancers cannot participate.Check my eligibility
What is being tested?
This study tests different doses (21 Gy, 23 Gy, and 25 Gy) of high dose rate brachytherapy for treating early stage prostate cancer. Brachytherapy involves placing radioactive material inside the body to kill cancer cells.See study design
What are the potential side effects?
Possible side effects from HDR brachytherapy include discomfort at the implant site, urinary issues such as frequency and urgency, bowel changes like diarrhea or pain during bowel movements, erectile dysfunction, and fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer was confirmed through a biopsy.
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My prostate cancer is classified as low-risk or favorable intermediate-risk.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 3 months after completion of implant for all patients enrolled (estimated to be 5 years and 3 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 3 months after completion of implant for all patients enrolled (estimated to be 5 years and 3 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Biochemical control experienced by patients with prostate cancer treated with an HDR implant
Secondary outcome measures
Rate of acute toxicity experienced by patients with prostate cancer treated with an HDR implant
Rate of late toxicity experienced by patients with prostate cancer treated with an HDR implant
Other outcome measures
Optimal dose of radiation
Trial Design
3Treatment groups
Experimental Treatment
Group I: HDR brachytherapy - 25 GyExperimental Treatment1 Intervention
-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 25 Gy.
Group II: HDR brachytherapy - 23 GyExperimental Treatment1 Intervention
-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 23 Gy.
Group III: HDR brachytherapy - 21 GyExperimental Treatment1 Intervention
-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 21 Gy.
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,947 Previous Clinical Trials
2,307,049 Total Patients Enrolled
17 Trials studying Prostate Cancer
4,241 Patients Enrolled for Prostate Cancer
Hiram A Gay, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
2 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer was confirmed through a biopsy.I cannot have general, spinal, or local anesthesia.My prostate cancer is classified as low-risk or favorable intermediate-risk.I had a prostate surgery that might affect the placement of an implant.I do not have any uncontrolled illnesses like infections or heart problems.I am 18 years old or older.I started hormone therapy for cancer up to 6 months before my planned treatment.I can take care of myself but might not be able to do heavy physical work.I can understand and am willing to sign the consent form.I have had cancer other than skin cancer in the last 5 years.I have had radiation therapy targeting my prostate or the area around it.
Research Study Groups:
This trial has the following groups:- Group 1: HDR brachytherapy - 21 Gy
- Group 2: HDR brachytherapy - 23 Gy
- Group 3: HDR brachytherapy - 25 Gy
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.
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