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NCT02516709 Clinical Trial

Linear Source Registry for Prostate Cancer

Prostate Cancer Clinical Trial

— CaRePC  

Official title:
CivaString Registry for Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02516709
Other study ID # CT003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2015
Est. completion date June 2023

Study information
Verified date September 2023
Source CivaTech Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Ongoing follow up for subjects implanted with the Linear Source String for prostate cancer.

Description:

This registry is being conducted to provide long term analysis on the use of the linear Civastring source for prostate cancer. Prospective data collection will record and demonstrate biochemical response rates. Long term side effects and adverse events will be monitored.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date June 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age > 18 years old - Plans to remain in care of enrolling physician for 5 years - > 5 years life expectancy - Signed informed consent - Enrolled within 6 weeks of implant or within 365 days of prior implant Exclusion Criteria: - Not willing or able to comply with protocol visit schedule

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Linear LDR Source
The Linear LDR source is a permanent interstitial brachytherapy implant containing palladium-103 sources for the treatment of prostate cancer.

Locations
Country Name City State
United States Chicago Prostate Cancer Center Chicago Illinois
United States Manhattan Medical Researcch New York New York
United States Bon Secours DePaul Medical Center Norfolk Virginia

Sponsors (1)
Lead Sponsor Collaborator
CivaTech Oncology

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Biochemical Response Rate (PSA) Up to 5 years
Secondary Side Effects (IPSS, IIEF, RFAS score) Up to 5 years
Secondary Adverse Events Up to 5 years
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