NCT02516709

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2015

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

8 years

First QC Date

August 4, 2015

Last Update Submit

September 7, 2023

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Biochemical Response Rate (PSA)

    Up to 5 years

Secondary Outcomes (2)

  • Side Effects (IPSS, IIEF, RFAS score)

    Up to 5 years

  • Adverse Events

    Up to 5 years

Interventions

Linear LDR SourceRADIATION

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

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Not willing or able to comply with protocol visit schedule

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chicago Prostate Cancer Center

Chicago, Illinois, 60559, United States

Location

Manhattan Medical Researcch

New York, New York, 10016, United States

Location

Bon Secours DePaul Medical Center

Norfolk, Virginia, 23505, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, serum

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Kristy Perez, PhD

    CivaTech Oncology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2015

First Posted

August 6, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

September 8, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(3)