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

Phase 3

Completed

• Conditions: Prostate Cancer; Adenocarcinoma of the Prostate
• Interventions: Drug: histrelin acetate

• Registration Number: NCT01697384
• Lead Sponsor: Endo Pharmaceuticals

Brief Summary

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.

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.

Study Timeline

• Study Start: 2000-04
• Primary Completion: 2003-08
• Study Completion: 2004-10
• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-10-02
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-29
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
one histrelin acetate 50 mg implant	histrelin acetate	The test product was a histrelin acetate 50 mg hydrogel implant surgically placed subdermally into the inner aspect of the upper arm.

Primary Outcome Measures

Name	Time	Method
Suppression of testosterone to chemical castration levels (<= 50 ng/dL)	52 weeks

Secondary Outcome Measures

Name	Time	Method
Pain measurements	52 weeks
PSA measurements	52 weeks
QoL outcomes	52 weeks