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

NCT ID: NCT01697384

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-04-30
• Study Completion Date: 2004-10-31

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.

Conditions

Prostate Cancer; Adenocarcinoma of the Prostate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

histrelin acetate

Intervention Type: DRUG

52 week implant

Interventions

histrelin acetate

52 week implant

Intervention Type: DRUG

Other Intervention Names

Vantas

Eligibility Criteria

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

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Regulatory Division

Role: STUDY_DIRECTOR

Endo Pharmaceuticals (formerly Valera/Indevus Pharmaceuticals)

References

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. doi: 10.1016/S0022-5347(05)00649-X.

Reference Type: RESULT

PMID: 16515997 (View on PubMed)

Other Identifiers

301

Identifier Type: -

Identifier Source: org_study_id