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CivaSheet With Radical Prostatectomy & Adjuvant External Beam Radiation

NCT03657108 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-03-20

Study results available
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Summary

A phase I single-arm open label dose escalation study to evaluate the maximum tolerated dose (MTD) and safety of Civasheet® with radical prostatectomy (RP) and adjuvant external beam radiation therapy (EBRT) in a 3+3 dose escalation design among participants with high risk prostate cancer (PCa).

Conditions

Interventions

RADIATION

Civasheet 60 Gy

implantable proposed doses of Civasheet are 60 Gy

RADIATION

Civasheet 75 Gy

implantable proposed doses of Civasheet are 75 Gy

RADIATION

Adjuvant external beam radiation therapy

45 Gy in 25 fractions

Sponsors & Collaborators

Principal Investigators

  • Ketan K. Badani, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-27
Primary Completion
2020-12-20
Completion
2023-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03657108 on ClinicalTrials.gov