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Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01697384
First received: July 13, 2011
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

Objective was to evaluate the efficacy and safety of the histrelin acetate subdermal implant (originally versus Lupron Depot-3 Month) in male patients with advanced prostate cancer during 52 weeks of treatment with the implant. After consultation w/ FDA, design was modified to eliminate the Lupron arm and continued the study as an open-label non-randomized study.

Primary endpoint was testosterone suppression, as assessed by the percent of patients whose testosterone indicated chemical castration levels (<=50 ng/dL) through 52 weeks of treatment with an implant.


Condition Intervention Phase
Prostate Cancer
Adenocarcinoma of the Prostate
Drug: histrelin acetate
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Suppression of testosterone to chemical castration levels (<= 50 ng/dL) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PSA measurements [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Pain measurements [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • QoL outcomes [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 138
Study Start Date: April 2000
Study Completion Date: October 2004
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: one histrelin acetate 50 mg implant
The test product was a histrelin acetate 50 mg hydrogel implant surgically placed subdermally into the inner aspect of the upper arm.
Drug: histrelin acetate
52 week implant
Other Name: Vantas

Detailed Description:

Other outcome measures included serum levels of LH, PSA, as well as non-clinical assessments, eg, WHO Performance Status, pain level assessment, and quality of life questionnaires. Safety was evaluated via adverse events, vital signs, clinical laboratory outcomes, physical examinations, and ECGs. Local tolerability outcomes were also evaluated.

An extension period for the study included annual replacement of the implant until the implant was approved by the FDA (October 12, 2004). Efficacy and safety were followed during the extension period.

  Eligibility

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

Key Inclusion Criteria:

  • Male Age 45 or older
  • Histologically confirmed adenocarcinoma of the prostate
  • Disease Staging III or IV
  • Clinical indication for androgen suppression therapy
  • Serum testosterone at least 150 ng/dL at screening
  • WHO Performance Scale 0 to 3
  • Life expectancy of at least one year

Key Exclusion Criteria:

  • Bilateral orchiectomy
  • Prior androgen-ablative therapy within past year
  • Second malignancy with 5 years (except adequately treated non-melanomatous skin cancer or superficial bladder cancer)
  • Spinal cord compression
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697384

Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Regulatory Division Endo Pharmaceuticals (formerly Valera/Indevus Pharmaceuticals)
  More Information

Publications:
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01697384     History of Changes
Other Study ID Numbers: 301
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

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014