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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
F-Sharp Trial 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.Check my eligibility
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.See study design
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.
F-Sharp Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
F-Sharp Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Toxicity rate
F-Sharp 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
156 Previous Clinical Trials
30,884 Total Patients Enrolled
Abhishek Solanki, MDPrincipal InvestigatorLoyola University
1 Previous Clinical Trials
24 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.I am on hormone therapy for my cancer and can provide the duration of this treatment.I can take care of myself and am up and about more than half of my waking hours.I am medically cleared to undergo surgery with general anesthesia.I am willing and able to sign the consent form for this study.My prostate cancer has returned locally without spreading to distant parts or bones.My prostate cancer came back in the same area after radiation.My initial cancer was early to mid-stage without confirmed spread to distant organs.I have had a detailed prostate biopsy.I have received specific types of radiation therapy for my cancer.I have severe gastrointestinal or urinary side effects.I haven't had chemotherapy or immunotherapy in the last month, except for ADT.
Research Study Groups:
This trial has the following groups:- Group 1: HDR Brachytherapy
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still available for this clinical experiment?
"Affirmative. Per the data on clinicaltrials.gov, this scientific experiment is actively enrolling individuals and was first posted in August 2017 with a most recent update occurring in May 2020 - targeting 50 participants at two locations."
Answered by AI
What is the enrollment capacity of this investigation?
"Affirmative. The clinicaltrials.gov website displays that this research initiative, which was initially uploaded on August 28th 2017, is currently recruiting participants. 50 potential patients need to be sourced from 2 distinct medical centers."
Answered by AI
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