A Phase 2, Open-label, Single-arm, Efficacy and Safety Study of MDV3100 in Patients With Hormone-naïve Prostate Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
A Phase 2, Open-label, Single-arm, Efficacy and Safety Study of MDV3100 in Patients With Hormone-naïve Prostate Cancer
Inclusion Criteria:
- Histologically confirmed prostate cancer (all stages) for whom androgen deprivation
therapy is indicated (except when indicated in a neoadjuvant/adjuvant therapy)
- Asymptomatic from prostate cancer
- Non-castrate level of testosterone (≥ 8 nmol/L (230 ng/dL)) at screening
- PSA ≥ 2 ng/mL at screening
Exclusion Criteria:
Has previously or is currently receiving:
- Hormonal therapy with intent to treat prostate cancer
- Systemic glucocorticoids
- Chemotherapy with the intent to treat prostate cancer
- Opiate analgesics for pain from prostate cancer
- Radiation therapy for treatment of the primary tumor or metastases
- Has history of known or suspected brain or skull metastases or leptomeningeal disease
- Has history of seizure including febrile seizure or any condition that may predispose
to seizure or history of loss of consciousness or transient ischemic attack
- Clinically significant cardiovascular disease
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The proportion of subjects with a PSA response
Outcome Description:
A PSA response is defined as a decline from baseline in PSA level of 80% or greater at week 25
Outcome Time Frame:
Day 169
Safety Issue:
No
Principal Investigator
Use Central Contact
Investigator Role:
Study Director
Investigator Affiliation:
Astellas Pharma Europe BV
Authority:
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Study ID:
9785-CL-0321
NCT ID:
NCT01302041
Start Date:
April 2011
Completion Date:
December 2013
Related Keywords:
- Prostate Cancer
- Prostate Cancer
- hormone-naïve
- prostate specific antigen
- bone turnover
- Prostatic Neoplasms
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