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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

July 13, 2011
September 27, 2012
April 2000
August 2003   (final data collection date for primary outcome measure)
Suppression of testosterone to chemical castration levels (<= 50 ng/dL) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01697384 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer
Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Advanced Prostate Cancer

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.

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Prostate Cancer
  • Adenocarcinoma of the Prostate
Drug: histrelin acetate
52 week implant
Other Name: Vantas
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.
Intervention: Drug: histrelin acetate
Schlegel PN; Histrelin Study Group. Efficacy and safety of histrelin subdermal implant in patients with advanced prostate cancer. J Urol. 2006 Apr;175(4):1353-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
October 2004
August 2003   (final data collection date for primary outcome measure)

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
Male
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01697384
301
No
Endo Pharmaceuticals
Endo Pharmaceuticals
Not Provided
Study Director: Regulatory Division Endo Pharmaceuticals (formerly Valera/Indevus Pharmaceuticals)
Endo Pharmaceuticals
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP