Study of Histrelin Subdermal Implant in Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01394263
First received: July 13, 2011
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

This trial was an open-label, multi-national, 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.


Condition Intervention Phase
Prostate Cancer
Adenocarcinoma of the Prostate
Drug: Histrelin hydrogel implant
Drug: Zoladex goserelin implant
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III, Open-Label Randomized, Parallel, Active-Control Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Metastatic Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • 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. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary efficacy was assessed by serum LH, PSA, and PAP, WHO Performance Status, Pain Level assessment, the National Prostatic Cancer Project (NPCP) assessment for objective clinical status, PSA status, time to disease progression, and QoL. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 59
Study Start Date: May 2000
Study Completion Date: December 2003
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Zoladex goserelin implant.
Zoladex goserelin implant: D, L-lactic and glycolic acids copolymer. Injected subcutaneously into the upper abdominal wall.
Drug: Zoladex goserelin implant
goserelin implant injection.
Other Name: Zoladex
Experimental: Histrelin Acetate implant
Histrelin hydrogel implant, 3 cm x 3.5 mm, containing 50 mg of histrelin acetate, surgically placed subdermally into the inner aspect of the upper arm.
Drug: Histrelin hydrogel implant
50 mg histrelin acetate in hyrogel implant
Other Name: Vantas

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Key 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
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01394263     History of Changes
Other Study ID Numbers: 302
Study First Received: July 13, 2011
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
prostate cancer
PSA
testosterone suppression

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014