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Brachytherapy

HDR Brachytherapy for Recurrent Prostate Cancer (F-Sharp Trial)

Phase 1 & 2
Waitlist Available
Led By Abhishek Solanki, MD
Research Sponsored by Loyola University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current ECOG Performance status Scale 0-2
Patient must be medically suitable to receive general anesthesia
Must not have
Uncontrolled inter-current illness including ongoing or active infection, severely symptomatic congestive heart failure, cardiac arrhythmia, recent myocardial infarction in last 6 months, or psychiatric illness/social situations that could limit compliance with study requirements
Preregistration GI or GU toxicity grade ≥ 3 as defined in CTCAE version 4.03
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying a new, minimally invasive technique to treat prostate cancer that has come back after prior radiotherapy.

Who is the study for?
Men with prostate cancer that has returned after radiotherapy can join this trial. They must have had a specific initial diagnosis (Stages T1-T3a, Nx/N0, Mx/M0), an ECOG score of 0-2 indicating they are fully active or ambulatory, and an IPSS less than 20 suggesting mild to moderate urinary symptoms. A recent biopsy confirming recurrence is required. The cancer should be localized without spread to lymph nodes or bones.
What is being tested?
The trial tests focal HDR Brachytherapy for recurrent prostate cancer post-radiotherapy. This technique targets the recurrent disease in the prostate with high-dose radiation while sparing healthy tissue. Radioactive material is temporarily placed in the affected area through a minimally invasive procedure and then removed.
What are the potential side effects?
Potential side effects include discomfort at the implant site, urinary issues such as frequency and urgency, bowel changes like diarrhea or rectal bleeding, erectile dysfunction due to nerve damage around the prostate, and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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I am medically cleared to undergo surgery with general anesthesia.
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My prostate cancer came back in the same area after radiation.
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My initial cancer was early to mid-stage without confirmed spread to distant organs.
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I have had a detailed prostate biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.
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I have severe gastrointestinal or urinary side effects.
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I haven't had chemotherapy or immunotherapy in the last month, except for ADT.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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
Toxicity rate

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: HDR BrachytherapyExperimental Treatment1 Intervention
HDR Brachytherapy implant, Up to 30 Gray (Gy) to target lesion in one to two fractions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HDR Brachytherapy
2014
N/A
~100

Find a Location

Who is running the clinical trial?

Loyola UniversityLead Sponsor
160 Previous Clinical Trials
31,369 Total Patients Enrolled
Abhishek Solanki, MDPrincipal InvestigatorLoyola University
1 Previous Clinical Trials
24 Total Patients Enrolled

Media Library

HDR Brachytherapy (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03312972 — Phase 1 & 2
Prostate Cancer Research Study Groups: HDR Brachytherapy
Prostate Cancer Clinical Trial 2023: HDR Brachytherapy Highlights & Side Effects. Trial Name: NCT03312972 — Phase 1 & 2
HDR Brachytherapy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03312972 — Phase 1 & 2
~6 spots leftby Nov 2025
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