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Brachytherapy

HDR Brachytherapy for Prostate Cancer

Q: What is the maximum capacity of participants being accepted into this research project?

<p>Affirmative. The information hosted on clinicaltrials.gov reveals that this research endeavour is actively recruiting participants. It was first posted online in February 2018 and the latest update occurred in March 2022, with a goal of enrolling 30 patients from 1 site.</p>

Q: Is this experiment currently open to enrolling additional participants?

<p>Affirmative, the information on clinicaltrials.gov shows that this medical experiment is actively enrolling volunteers. The trial was first made available to the public on February 27th 2018 and its criteria were recently updated March 14th 2022. 30 participants are necessary at a single investigation centre.</p>

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 below

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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 3 months after completion of implant for all patients enrolled (estimated to be 5 years and 3 months) for reporting.

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

Group III: HDR brachytherapy - 21 GyExperimental Treatment1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,776 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

Media Library

HDR brachytherapy (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03424850 — Phase 1 & 2

Prostate Cancer Research Study Groups: HDR brachytherapy - 21 Gy, HDR brachytherapy - 23 Gy, HDR brachytherapy - 25 Gy

Prostate Cancer Clinical Trial 2023: HDR brachytherapy Highlights & Side Effects. Trial Name: NCT03424850 — Phase 1 & 2

HDR brachytherapy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03424850 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity of participants being accepted into this research project?

"Affirmative. The information hosted on clinicaltrials.gov reveals that this research endeavour is actively recruiting participants. It was first posted online in February 2018 and the latest update occurred in March 2022, with a goal of enrolling 30 patients from 1 site."

Answered by AI

Is this experiment currently open to enrolling additional participants?

"Affirmative, the information on clinicaltrials.gov shows that this medical experiment is actively enrolling volunteers. The trial was first made available to the public on February 27th 2018 and its criteria were recently updated March 14th 2022. 30 participants are necessary at a single investigation centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy

2018. "Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03424850.

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