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Brachytherapy

CivaSheet + Radiation Therapy for Prostate Cancer

N/A
Waitlist Available
Led By Ketan K. Badani, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at least 6 months after ebrt, up to 40 months
Awards & highlights

Study Summary

This trial is testing a new treatment for prostate cancer that involves surgery and radiation therapy. They are testing how well it works and what the side effects are.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at least 6 months after ebrt, up to 40 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at least 6 months after ebrt, up to 40 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
Maximum Tolerable Dose (MTD)
Secondary outcome measures
Number of Participants With Biochemical Recurrence (BCR)
Number of Participants With Erectile Dysfunction
Number of Participants With PSA Persistence
+2 more
Other outcome measures
Number of Participants With Acute Radiation Toxicity
Number of Participants With Late Radiation Toxicity
Number of Radiation Adverse Event(s)

Trial Design

4Treatment groups
Experimental Treatment
Group I: group 2 of 75 Gy doseExperimental Treatment2 Interventions
The fourth 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 75 Gy + Adjuvant external beam radiation therapy
Group II: group 2 of 60 Gy doseExperimental Treatment2 Interventions
The second 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 60 Gy + Adjuvant external beam radiation therapy
Group III: group 1 of 75 Gy doseExperimental Treatment2 Interventions
The third 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 75 Gy + Adjuvant external beam radiation therapy
Group IV: group 1 of 60 Gy doseExperimental Treatment2 Interventions
The first 3 subsequent patients with high risk prostate cancer will be undergoing radical prostatectomy Interventions: Civasheet 60 Gy + Adjuvant external beam radiation therapy

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,280 Total Patients Enrolled
11 Trials studying Prostate Cancer
23,879 Patients Enrolled for Prostate Cancer
Ketan K. Badani, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

CivaSheet (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03657108 — N/A
Prostate Cancer Research Study Groups: group 1 of 60 Gy dose, group 2 of 60 Gy dose, group 2 of 75 Gy dose, group 1 of 75 Gy dose
Prostate Cancer Clinical Trial 2023: CivaSheet Highlights & Side Effects. Trial Name: NCT03657108 — N/A
CivaSheet (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03657108 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
CivaSheet With Radical Prostatectomy & Adjuvant External Beam Radiation
Ketan Badani 2018. "CivaSheet With Radical Prostatectomy & Adjuvant External Beam Radiation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03657108.
~1 spots leftby Apr 2025
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