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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01697384

Enrollment

138

Registered

2012-10-02

Start date

2000-04-30

Completion date

2004-10-31

Last updated

2024-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer, Adenocarcinoma of the Prostate

Keywords

prostate cancer, PSA

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.

Interventions

DRUGhistrelin acetate

52 week implant

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
PSA measurements	52 weeks
Pain measurements	52 weeks
QoL outcomes	52 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026