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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-implant day 30
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-implant day 30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-implant day 30
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent tumor coverage
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
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Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
561 Previous Clinical Trials
33,079 Total Patients Enrolled
57 Trials studying Prostate Cancer
3,408 Patients Enrolled for Prostate Cancer
National Institutes of Health (NIH)NIH
2,723 Previous Clinical Trials
7,495,711 Total Patients Enrolled
28 Trials studying Prostate Cancer
6,937 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,728 Previous Clinical Trials
40,965,983 Total Patients Enrolled
565 Trials studying Prostate Cancer
529,188 Patients Enrolled for Prostate Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with prostate adenocarcinoma.You have mild to moderate urinary symptoms, with a score of 20 or less on the International Prostate Symptom Score (IPSS) questionnaire.You have metal implants in your body or have a fear of small spaces that cannot be treated with medication. You also have a medical condition that makes it unsafe for you to have an MRI scan.My breast cancer is in an early stage and may not have spread to lymph nodes or other parts.You have an implanted device that makes it difficult to see internal structures during imaging.My prostate cancer has a Gleason score of 6 to 7.I have been diagnosed with another cancer within the last 3 years.I can do most of my daily activities without help.I can have a PSMA PET scan for cancer staging.I have had radiation therapy in the pelvic area before.
Research Study Groups:
This trial has the following groups:- Group 1: Focal 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.
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