Phave IV, Multicenter, Open-label Study to Collect VANTAS® Implant Retrieval Data From Patients With Advanced Prostate Cancer and Difficult to Remove Implants
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.
Observational Model: Cohort, Time Perspective: Cross-Sectional
The number (and percent) of successfully located and removed implants was the primary outcome measure.
cross-sectional design, data collected at time of explant procedure.
United States: Food and Drug Administration