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Brachytherapy

High-Dose-Rate Brachytherapy for Prostate Cancer

N/A
Recruiting
Led By Hong Zhang
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No Rectal fistula/fissure
No pelvic arch interference
Must not have
TURP within 6 months prior to enrollment
Patients with neuroendocrine or small cell carcinoma of the prostate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will help researchers learn more about how effective high-dose-rate brachytherapy is in treating prostate cancer and preventing its recurrence.

Who is the study for?
This trial is for men over 18 with prostate cancer that has come back, seen on an AXUMIN PET scan, after previous treatments like radiation or brachytherapy. They must be fit for anesthesia, have a good performance status (KPS ≥ 70%), and no severe urinary issues (IPSS score <16). Men with bowel diseases, inability to understand English, neuroendocrine prostate cancer types, recent TURP surgery or evidence of cancer spread outside the prostate are not eligible.
What is being tested?
The study tests high-dose-rate (HDR) brachytherapy—a type of internal radiation therapy—on patients whose prostate cancer has returned within the gland only. The effectiveness of this targeted treatment will be evaluated in those who've had prior radiation therapy at least two years ago.
What are the potential side effects?
Potential side effects include discomfort or pain at the implant site, urinary issues such as frequency and urgency, bowel changes like diarrhea or bleeding, erectile dysfunction and rare risks associated with anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have a rectal fistula or fissure.
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My pelvic area does not interfere with medical procedures.
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I am mostly able to care for myself.
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I have never had a urethral stricture.
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I am 18 years old or older.
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I had prostate cancer treated with radiation aimed at curing it over 2 years ago.
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I am healthy enough for general or spinal anesthesia.
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My prostate cancer has come back, confirmed by a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had a prostate surgery within the last 6 months.
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I have neuroendocrine or small cell prostate cancer.
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I have a history of Crohn's disease, ulcerative colitis, or radiation proctitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Number of patients with prostate-specific antigen (PSA) levels rising of 2ng/ml or above
Secondary study objectives
Progression Free Survival

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: Experimental: High-Dose-Rate prostate brachytherapyExperimental Treatment1 Intervention
High-Dose-Rate brachytherapy, 2 fractions

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
872 Previous Clinical Trials
550,079 Total Patients Enrolled
Hong ZhangPrincipal InvestigatorUniversity of Rochester Wilmot Cancer Center
6 Previous Clinical Trials
1,326 Total Patients Enrolled

Media Library

High-Dose-Rate Brachytherapy (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04645810 — N/A
Brachytherapy Research Study Groups: Experimental: High-Dose-Rate prostate brachytherapy
Brachytherapy Clinical Trial 2023: High-Dose-Rate Brachytherapy Highlights & Side Effects. Trial Name: NCT04645810 — N/A
High-Dose-Rate Brachytherapy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04645810 — N/A
~4 spots leftby May 2026
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