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Vantas Implant Retrieval Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01013025
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : July 14, 2011
Information provided by:
Endo Pharmaceuticals

Brief 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. 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 or disease Intervention/treatment
Prostate Cancer Procedure: Ultrasound or CT or MRI to locate implant

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.

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Study Type : Observational
Actual Enrollment : 12 participants
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
Study Start Date : July 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes 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.

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).
Layout table for additonal information Identifier: NCT01013025    
Other Study ID Numbers: 303
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: July 14, 2011
Last Verified: July 2011
Keywords provided by Endo Pharmaceuticals:
prostate cancer
implant retrieval
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases