The purpose of this open-label, single-arm, multicenter, post-marketing trial is to evaluate long-term safety of Firmagon® in approximately 230 Indian patients diagnosed with advanced hormone-dependent prostate cancer requiring androgen deprivation therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
230
S. P Medical College and AG of Hospitals
Bikaner, Rajasthan, India
Krishna Institute of Medical Sciences
Secunderabad, Telangana, India
Frequency of adverse events
Time frame: Up to Day 364
Severity of adverse events
Time frame: Up to Day 364
Clinically significant changes in laboratory values (hematology and clinical biochemistry)
Time frame: From baseline to Day 364
Clinically significant changes in vital signs
Time frame: From baseline to Day 364
Cumulative probability of no Prostate Specific Antigen (PSA) failure
PSA failure defined as an increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart
Time frame: Up to Day 364
Cumulative probability of Progression Free Survival (PFS)
PFS defined as PSA failure, death from any cause, or introduction of additional therapy related to prostate cancer, whichever is first
Time frame: Up to Day 364
Change in International Prostate Symptom Score (IPSS)
Time frame: From baseline to Day 364
Change in physician's satisfaction score
Time frame: From baseline to Day 364
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