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Brachytherapy

Focal Brachytherapy for Prostate Cancer

Phase < 1
Recruiting
Led By Daniel Song, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adenocarcinoma of the prostate
Clinical stages (not radiographic stage) T1c - T2a, Nx or N0, Mx or M0
Must not have
History of other malignancy diagnosed within the past 3 years
Prior history of pelvic radiation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-implant day 30
Awards & highlights
No Placebo-Only Group

Summary

This trial will help the PI learn if 18F-DCFPyl PSMA can help identify clinically significant tumors in patients who will undergo brachytherapy, as well as areas which are uninvolved or contain only clinically insignificant disease.

Who is the study for?
Men with prostate cancer can join this trial if they have a specific type of tumor (adenocarcinoma), are in fairly good health, and their cancer hasn't spread far. Their prostate must be below a certain size, and they need to be able to handle a special PET scan. They can't participate if they've had pelvic radiation before or other major illnesses that could affect the treatment.
What is being tested?
The study is testing focal brachytherapy guided by an advanced imaging technique using PSMA PET scans. The goal is to target only significant tumors while reducing damage to healthy areas, potentially lowering side effects.
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort from the procedure, urinary issues due to inflammation or damage near the treated area, and typical risks associated with undergoing PET scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with prostate adenocarcinoma.
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My breast cancer is in an early stage and may not have spread to lymph nodes or other parts.
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My prostate cancer has a Gleason score of 6 to 7.
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I can do most of my daily activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with another cancer within the last 3 years.
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I have had radiation therapy in the pelvic area before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-implant day 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-implant day 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent tumor coverage

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: Focal brachytherapyExperimental Treatment2 Interventions
Drug: 18F-DCFPyl Other names: PET, PSMA Procedure: Focal brachytherapy with PSMA PET imaging Other names: Radiotherapy, Radiation, Prostate seed implant, Focal therapy

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
570 Previous Clinical Trials
33,210 Total Patients Enrolled
57 Trials studying Prostate Cancer
3,408 Patients Enrolled for Prostate Cancer
National Institutes of Health (NIH)NIH
2,811 Previous Clinical Trials
8,161,238 Total Patients Enrolled
26 Trials studying Prostate Cancer
6,175 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,445 Total Patients Enrolled
515 Trials studying Prostate Cancer
332,940 Patients Enrolled for Prostate Cancer

Media Library

Focal Brachytherapy (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03861676 — Phase < 1
Prostate Cancer Research Study Groups: Focal brachytherapy
Prostate Cancer Clinical Trial 2023: Focal Brachytherapy Highlights & Side Effects. Trial Name: NCT03861676 — Phase < 1
Focal Brachytherapy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03861676 — Phase < 1
~13 spots leftby Dec 2028