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

Phase 3
45 Years
Not Enrolling
Prostate Cancer, Adenocarcinoma of the Prostate

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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.


Inclusion Criteria:

- Male patients with histologically confirmed adenocarcinoma of the prostate

- Disease staging of M1 or apparent failure of the initial definitive therapy (e.g.,
prostatectomy, radiation, etc.), suggested by either an elevated PSA (5 ng/mL or
greater within the previous 28 days), or when below 5ng/mL, rising PSA values
(elevation from previous measurement greater than or equal to 0.1 ng/mL on three
consecutive measurements at least two weeks apart with at least one of these
measurements being within the last 28 days which may include the Screening Visit
result, if needed)

- Clinically indicated for androgen suppression therapy

- Age 45 years or older

- Serum testosterone level of 150 ng/dL (5.25 nmol/L) or greater at screening

- PSA level of 5ng/mL or greater within the previous 28 days, or an increase in PSA
(elevation from previous measurements greater than or equal to 0.1ng/mL on three
consecutive measurements at least two weeks apart)

Key Exclusion Criteria:

- Bilateral orchiectomy

- Prior androgen-ablative or systemic corticosteroid therapy within the past year

- Second malignancy within five years, except adequately treated nonmelanomatous skin
cancer or superficial bladder cancer

- Spinal cord compression

- Location of vertebral metastases that indicate risk of spinal cord compression during
initial treatment period in the opinion of the Investigator

- Brain metastasis previously confirmed by CT scan

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Suppression of testosterone via the percent of patients whose testosterone was at or below chemical castration levels (<=50 n/dL) through 52 weeks of treatment.

Outcome Time Frame:

52 weeks

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2000

Completion Date:

December 2003

Related Keywords:

  • Prostate Cancer
  • Adenocarcinoma of the Prostate
  • prostate cancer
  • PSA
  • testosterone suppression
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms