Linear Source Registry for Prostate Cancer (CaRePC)

September 7, 2023 updated by: CivaTech Oncology

CivaString Registry for Prostate Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60559
        • Chicago Prostate Cancer Center
    • New York
      • New York, New York, United States, 10016
        • Manhattan Medical Researcch
    • Virginia
      • Norfolk, Virginia, United States, 23505
        • Bon Secours DePaul Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients currently indicated for brachytherapy, implanted with the linear LDR source for prostate cancer with a life expectancy greater than 5 years

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biochemical Response Rate (PSA)
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Side Effects (IPSS, IIEF, RFAS score)
Time Frame: Up to 5 years
Up to 5 years
Adverse Events
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CivaTech Oncology

Investigators

  • Study Director: Kristy Perez, PhD, CivaTech Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

August 4, 2015

First Submitted That Met QC Criteria

August 5, 2015

First Posted (Estimated)

August 6, 2015

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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