Trial Information

Phase III, Open-Label Randomized, Parallel, Active-Control Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Metastatic Prostate Cancer

This trial was an open-label, randomized, parallel treatment, active-control multicenter
study in adult males with documented metastatic prostate cancer disease who were judged to
be candidates for hormone therapy.

Within 21 days prior to implant insertion, all prospective enrollees were entered into a
screening period to provide medical history, demographic information, physical examination,
laboratory evaluations, 12-lead ECG, bone scan, chest x-ray, liver ultrasound, concomitant
medications and procedures, and a physician assessment including pain level and WHO
performance scale in order to assess eligibility for the study. Written informed consent
was obtained before any procedures were undertaken.

Once inclusion/exclusion criteria were met, baseline evaluations (physical assessment and
examination, vital signs and weight, clinical laboratory evaluations, concomitant
medications and procedures, adverse events, and a Quality of Life questionnaire) were
obtained prior to implant insertion on Day 1 [Visit 1]. All appropriately screened patients
were to then receive either histrelin acetate 50-mg or Zoladex 3-Month 10.8 mg implant based
on 1:1 randomization at Day 1 [Visit 1]. Patients with implants were evaluated at Week 1
and 2 [Visits 2 and 3] post-insertion for testosterone and PSA concentrations, vital signs,
adverse events, and concomitant medications and procedures. The Zoladex implants were
replaced at Weeks 12, 24, 36, and 48 [Visits 6, 9, 12, and 15], while the histrelin acetate
implants were replaced at Week 52 (Visit 16), respectively. Patients were followed monthly
from Weeks 4 to 60 [Visits 4 to 18] to evaluate testosterone and PSA concentrations, adverse
events, concomitant medications and procedures, disease progression, and urine and serum
histrelin in the renal/hepatic impairment subgroup. Periodic clinical and subjective
assessments were completed for all patients.