ClinicalTrials.gg
CompletedNCT02516709CaRePCUpdated Sep 8, 2023

Linear Source Registry for Prostate Cancer

An observational study in Prostate Cancer, sponsored by CivaTech Oncology. Completed at 3 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-08.

Sponsored by CivaTech Oncology · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's enrollment of 60 is below the median of 200 across 1,200 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

CivaTech Oncology is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Not willing or able to comply with protocol visit schedule
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Interventions

  • RadiationLinear LDR Source

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

06

What researchers measure

Primary outcomes

  1. Biochemical Response Rate (PSA)

    Time frame: Up to 5 years

Secondary outcomes

  1. Side Effects (IPSS, IIEF, RFAS score)

    Time frame: Up to 5 years

  2. Adverse Events

    Time frame: Up to 5 years

07

Study locations

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

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2015, a primary completion of Jun 2023 and a completion of Jun 2023. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 4, 2015
First posted
Aug 6, 2015
Start
Jun 2015
Primary completionActual
Jun 2023
CompletionActual
Jun 2023
Last update
Sep 8, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02516709
Lead sponsor
CivaTech Oncology
Responsible party
Sponsor
First posted
Aug 6, 2015
Start date
Jun 2015
Primary completion
Jun 2023
Completion
Jun 2023
Last update
Sep 8, 2023

Study contacts

Kristy Perez, PhD
study director · CivaTech Oncology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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