Linear Source Registry for Prostate Cancer | NCT02516709

Studies
Linear Source Registry for Prostate Cancer

NCT02516709

Sponsor

CivaTech Oncology

Status

Completed

Last Update Posted

Sep 8, 2023Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Linear LDR Source

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Jun 2023Actual

Completion Date

Jun 2023Actual

First Submitted Date

Aug 4, 2015

First Submission Date that Met QC Criteria

Aug 5, 2015

First Posted Date

Aug 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2023

Last Update Posted Date

Sep 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Linear LDR Source	Radiation	The Linear LDR source is a permanent interstitial brachytherapy implant containing palladium-103 sources for the treatment of prostate cancer.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kristy Perez, PhD	CivaTech Oncology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chicago Prostate Cancer Center		Chicago	Illinois	60559	United States
Manhattan Medical Researcch

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided