Prostate CancerNCT01013025
Vantas Implant Retrieval Study
An observational study of Prostate Cancer, run by Endo USA Inc., a Keenova Therapeutics Company.
Trial summary
The main study objective was to collect implant retrieval information in 10 patients using Vantas®, the 50 mg histrelin implant. Patients who had been identified as having a difficult to locate or non-palpable implant were to have been enrolled. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Ultrasound or CT or MRI to locate implant
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Jun 2007
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The study was planned to include approximately 10 patients with locally advanced or metastatic prostate cancer who satisfied the inclusion and exclusion criteria.
Who may be able to join
- Were male patients with adenocarcinoma of the prostate;
- Were age 45 years or older;
- Had received a Vantas® implant;
- Had difficult to locate or non-palpable implant at time of implant retrieval;
- Had the ability to undergo ultrasound, and/or CT, and/or MRI within two weeks of Screening Visit;
- Voluntarily provided Informed Consent prior to the performance of any study-specific procedures.
Who cannot join
- Major medical or psychiatric illness that would interfere with return visits; patient not suitable (e.g., noncompliance history) for study in opinion of the Investigator or Sponsor;
- Participated in a clinical trial for an investigational agent within 30 days prior to the Screening Visit (unless enrolled in Protocol 301 Extension).
About this study
Official title: Phave IV, Multicenter, Open-label Study to Collect VANTAS® Implant Retrieval Data From Patients With Advanced Prostate Cancer and Difficult to Remove Implants
The main study objective was to collect implant retrieval information in 10 patients using Vantas®, the 50 mg histrelin implant. Patients who had been identified as having a difficult to locate or non-palpable implant were to have been enrolled. Sites were to adhere to the instructions in the Package Insert, which included specialized investigations such as ultrasound, CT, and MRI, to be used for the location and removal of implants.
Read the detailed description
Up to 50 centers using Vantas, the recently approved histrelin implant as part of their urology practice for treating patients with advanced prostate cancer, were to be identified for participation in this Phase IV post-marketing trial. Up to 10 patients who had been implanted with Vantas at these participating centers, and who had difficult to locate or non-palpable implants at the time of removal, were to be enrolled in this trial. A Screening Visit was to be conducted to consent the patient and to collect basic medical and safety information for patient participation. Upon patient enrollment, up to three subsequent Visits (Visits 1, 2, and 3) were to be conducted (within 2 weeks of the Screening Visit). The investigator was to locate and remove the implant by following the instructions provided in the protocol. Methods for location of the implant included ultrasound, CT, or MRI procedures. The visit at which the implant was successfully located and removed was to be the final study visit for the patient. Upon successful retrieval of the implant or a determination that, per Study Instructions, the implant cannot be located/removed, the study was completed for the patient. No information was to be collected on re-implantation of a new implant. Safety was to be monitored throughout the two week study. Blood samples for testosterone and PSA were only collected at the Screening Visit. The implants removed from the patients were to be returned to Indevus Pharmaceuticals for analysis.
- Conditions
- Prostate Cancer
- Being tested
- Ultrasound or CT or MRI to locate implant
- Keywords
- prostate cancer, implant retrieval
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound or CT or MRI to locate implantProcedure or surgery
Also called Vantas
Scanning methods (eg, ultrasound, CT, or MRI) were used to locate the implant.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with Vantas implant | Patients were enrolled if they had had a Vantas implant placed for treatment of adenocarcinoma of the prostate, and if the patients were scheduled for explant of the implant, and the physician had difficulty locating the implant. Receives: Procedure: Ultrasound or CT or MRI to locate implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number (and percent) of successfully located and removed implants was the primary outcome measure.
Measured: cross-sectional design, data collected at time of explant procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startJul 2006
- Primary completionJun 2007
- Study completionJun 2007
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
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013025
- Sponsor's protocol ID
- 303
- Status last verified
- Dec 2023
- First submitted
- 12 Nov 2009
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phave IV, Multicenter, Open-label Study to Collect VANTAS® Implant Retrieval Data From Patients With Advanced Prostate Cancer and Difficult to Remove Implants
- ClinicalTrials.gov ID
- NCT01013025
- Acronym / sponsor ID
- 303
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, implant retrieval
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 13 Nov 2009 (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.
The main study objective was to collect implant retrieval information in 10 patients using Vantas®, the 50 mg histrelin implant. Patients who had been identified as having a difficult to locate or non-palpable implant were to have been enrolled. Sites were to adhere to the instructions in the Package Insert, which included specialized investigations such as ultrasound, CT, and MRI, to be used for the location and removal of implants.
Detailed description
Up to 50 centers using Vantas, the recently approved histrelin implant as part of their urology practice for treating patients with advanced prostate cancer, were to be identified for participation in this Phase IV post-marketing trial. Up to 10 patients who had been implanted with Vantas at these participating centers, and who had difficult to locate or non-palpable implants at the time of removal, were to be enrolled in this trial. A Screening Visit was to be conducted to consent the patient and to collect basic medical and safety information for patient participation. Upon patient enrollment, up to three subsequent Visits (Visits 1, 2, and 3) were to be conducted (within 2 weeks of the Screening Visit). The investigator was to locate and remove the implant by following the instructions provided in the protocol. Methods for location of the implant included ultrasound, CT, or MRI procedures. The visit at which the implant was successfully located and removed was to be the final study visit for the patient. Upon successful retrieval of the implant or a determination that, per Study Instructions, the implant cannot be located/removed, the study was completed for the patient. No information was to be collected on re-implantation of a new implant. Safety was to be monitored throughout the two week study. Blood samples for testosterone and PSA were only collected at the Screening Visit. The implants removed from the patients were to be returned to Indevus Pharmaceuticals for analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with Vantas implant | – | Procedure: Ultrasound or CT or MRI to locate implantPatients were enrolled if they had had a Vantas implant placed for treatment of adenocarcinoma of the prostate, and if the patients were scheduled for explant of the implant, and the physician had difficulty locating the implant. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study was planned to include approximately 10 patients with locally advanced or metastatic prostate cancer who satisfied the inclusion and exclusion criteria.
Key inclusion criteria (6 listed)
- Were male patients with adenocarcinoma of the prostate;
- Were age 45 years or older;
- Had received a Vantas® implant;
- Had difficult to locate or non-palpable implant at time of implant retrieval;
- Had the ability to undergo ultrasound, and/or CT, and/or MRI within two weeks of Screening Visit;
Key exclusion criteria (2 listed)
- Major medical or psychiatric illness that would interfere with return visits; patient not suitable (e.g., noncompliance history) for study in opinion of the Investigator or Sponsor;
- Participated in a clinical trial for an investigational agent within 30 days prior to the Screening Visit (unless enrolled in Protocol 301 Extension).
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 |
|---|---|---|
| Ultrasound or CT or MRI to locate implantAlso: VantasScanning methods (eg, ultrasound, CT, or MRI) were used to locate the implant. | Procedure or surgery | Patients treated with Vantas implant |
Primary outcome
The number (and percent) of successfully located and removed implants was the primary outcome measure.
Time frame: cross-sectional design, data collected at time of explant procedure.
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 2 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Endo USA Inc., a Keenova Therapeutics Company.
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 6 inclusion and 2 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 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The number (and percent) of successfully located and removed implants was the primary outcome measure. (time frame: cross-sectional design, data collected at time of explant procedure.). 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 2 Jan 2024.