Vantas Implant Retrieval Study

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01013025
First received: November 12, 2009
Last updated: July 13, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Prostate Cancer
Procedure: Ultrasound or CT or MRI to locate implant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: July 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Procedure: Ultrasound or CT or MRI to locate implant
Scanning methods (eg, ultrasound, CT, or MRI) were used to locate the implant.
Other Name: Vantas

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01013025     History of Changes
Other Study ID Numbers: 303
Study First Received: November 12, 2009
Last Updated: July 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
prostate cancer
implant retrieval

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 29, 2014