Vantas Implant Retrieval Study

Launched by ENDO PHARMACEUTICALS · Nov 12, 2009

Keywords

ClinConnect Summary

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 enroll...

Gender

MALE

Eligibility 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).