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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01697384
Recruitment Status : Completed
First Posted : October 2, 2012
Last Update Posted : October 2, 2012
Information provided by (Responsible Party):
Endo Pharmaceuticals

July 13, 2011
October 2, 2012
October 2, 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 ]
Same as current
No Changes Posted
  • PSA measurements [ Time Frame: 52 weeks ]
  • Pain measurements [ Time Frame: 52 weeks ]
  • QoL outcomes [ Time Frame: 52 weeks ]
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.

Phase 3
Intervention Model: Single Group Assignment
Masking: None (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 Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: Male
45 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
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