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Brachytherapy

High-Dose-Rate Brachytherapy for Prostate Cancer

Phase < 1
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Progression Free Survival

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
840 Previous Clinical Trials
534,238 Total Patients Enrolled
7 Trials studying Prostate Cancer
545 Patients Enrolled for Prostate Cancer
Hong ZhangPrincipal InvestigatorUniversity of Rochester Wilmot Cancer Center
5 Previous Clinical Trials
1,308 Total Patients Enrolled

Media Library

High-Dose-Rate Brachytherapy (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04645810 — Phase < 1
Prostate Cancer Research Study Groups: Experimental: High-Dose-Rate prostate brachytherapy
Prostate Cancer Clinical Trial 2023: High-Dose-Rate Brachytherapy Highlights & Side Effects. Trial Name: NCT04645810 — Phase < 1
High-Dose-Rate Brachytherapy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04645810 — Phase < 1

Frequently Asked Questions

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

Are there any available slots still open for participants to join this trial?

"Affirmative. As per the clinicaltrials.gov database, applications are still being accepted for this experiment which was posted on October 29th 2021 and last modified on the same day. The research is looking to include 12 volunteers from a single medical centre in its cohort."

Answered by AI

What is the cap for individuals taking part in this research?

"Affirmative. The clinical trial, which was initially published on October 29th 2021 and recently updated the same day, is currently in search of 12 participants from a single medical centre. This information can be found on clinicaltrials.gov."

Answered by AI
~0 spots leftby May 2024