Prostate CancerCaRePCNCT02516709
Linear Source Registry for Prostate Cancer
An observational study of Prostate Cancer, run by CivaTech Oncology at 3 sites in United States.
Trial summary
Ongoing follow up for subjects implanted with the Linear Source String for prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Linear LDR Source
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2015to Jun 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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
Who cannot join
- Not willing or able to comply with protocol visit schedule
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Chicago Prostate Cancer Center
Chicago, Illinois, 60559
Manhattan Medical Researcch
New York, New York, 10016
Bon Secours DePaul Medical Center
Norfolk, Virginia, 23505
About this study
Official title: CivaString Registry for Prostate Cancer
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.
- Conditions
- Prostate Cancer
- Being tested
- Linear LDR Source
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linear LDR SourceRadiation
The Linear LDR source is a permanent interstitial brachytherapy implant containing palladium-103 sources for the treatment of prostate cancer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Response Rate (PSA)
Measured: Up to 5 years
Secondary outcomes (2)
Side Effects (IPSS, IIEF, RFAS score)
Measured: Up to 5 years
Adverse Events
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2023
- Study completionJun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- CivaTech Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristy Perez, PhD, Study director, CivaTech Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516709
- Sponsor's protocol ID
- CT003
- Acronym
- CaRePC
- Status last verified
- Sep 2023
- First submitted
- 4 Aug 2015
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CivaString Registry for Prostate Cancer
- ClinicalTrials.gov ID
- NCT02516709
- Acronym / sponsor ID
- CaRePC / CT003
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CivaTech OncologyIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jun 2023 (actual)
- Study completion
- Jun 2023 (actual)
- First posted
- 6 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Not willing or able to comply with protocol visit schedule
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linear LDR SourceThe Linear LDR source is a permanent interstitial brachytherapy implant containing palladium-103 sources for the treatment of prostate cancer. | Radiation | – |
Primary outcome
Biochemical Response Rate (PSA)
Time frame: Up to 5 years
2 secondary outcomes
Side Effects (IPSS, IIEF, RFAS score)
Time frame: Up to 5 years
Adverse Events
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristy Perez, PhD study director
CivaTech Oncology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by CivaTech Oncology at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical Response Rate (PSA) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.