To assess the effect of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer
Two doses of ASP3550 were administered to patients with prostate cancer. The primary efficacy variable was the effect of ASP3550 on the maintenance of serum testosterone suppression. In addition, the safety and pharmacokinetics of ASP3550 will be investigated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
273
subcutaneous administration
Unnamed facility
Chugoku, Japan
Unnamed facility
Chūbu, Japan
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kansai, Japan
Unnamed facility
Kanto, Japan
Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment
Time frame: 1 Year
Proportion of patients with testosterone surge
Time frame: 1 Year
Percentage change in serum PSA
Time frame: 1 Year
Changes in serum levels of testosterone, LH, FSH and PSA over time
Time frame: 1 Year
Time to the recurrence of serum PSA
Time frame: 1 Year
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Unnamed facility
Kyusyu, Japan
Unnamed facility
Shikoku, Japan
Unnamed facility
Tōhoku, Japan