Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Advanced Prostate Cancer
45 Years
N/A
Male
Prostate Cancer, Adenocarcinoma of the Prostate
Trial Information
Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Advanced Prostate Cancer
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Suppression of testosterone to chemical castration levels (<= 50 ng/dL)
Outcome Time Frame:
52 weeks
Safety Issue:
Yes
Principal Investigator
Regulatory Division
Investigator Role:
Study Director
Investigator Affiliation:
Endo Pharmaceuticals (formerly Valera/Indevus Pharmaceuticals)
Authority:
United States: Food and Drug Administration
Study ID:
301
NCT ID:
NCT01697384
Start Date:
April 2000
Completion Date:
October 2004
Related Keywords:
- Prostate Cancer
- Adenocarcinoma of the Prostate
- prostate cancer, PSA
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Prostatic Neoplasms
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