NCT Number: NCT02669147
This is a prospective observational study to evaluate effectiveness and safety of Enzalutamide for Castration Resistant Prostate Cancer (CRPC) patients who decided to administer Enzalutamide after anti-androgen therapy.
CRPC Patients who are observed PSA or disease progression after anti-androgen therapy and decided to administrate Enzalutamide will dose the Enzalutamide 160 mg orally once daily and observed the practical treatment. Total research term is for 4 years, consists of 2-year case registration terms and 2-year observational terms.
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Notify Me20 year and older
Male
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Note 1) anti-androgen alternating therapy is defined as the therapy of flutamide administration after bicalutamide.
Note 2) Disease progression criteria during or after anti-androgen alternating therapy
① PSA progression during or after anti-androgen alternating therapy: PSA increased more than 25% compare to the lowest test results after initial dose of anti-androgen alternating therapy (flutamide) and the increasing is more than 2ng/ml.
②Confirmed disease progression of soft tissue lesion defined as RECIST v1.1.
③Confirmed disease progression of bone lesion defined as 2 or more of new appearance of bone lesion on bone scintigraphy.
Exclusion criteria
Time frame: 50 months
OS is defined as time from date of initial dose until date of death from any cause. In the case of any new chemotherapy added or changed to another treatment to prostate cancer, the conducted date will be applied. When patient is no longer traceable, the final confirmed date as alive will be applied to OS.
Time frame: 50 months
Prostate specific antigen (PSA) progression-free survival is defined as time from date of initial dose until the date of first confirmed PSA progression (an increase in PSA of >= 25% and >= 2 ng/ml above the nadir after initial dose) or date of death from any cause, whichever comes first. In the case of any new chemotherapy added or changed to another treatment to prostate cancer, the conducted date will be applied.
Time frame: 50 months
PFS is defined as time from date of initial dose until the date of first confirmed progression or date of death from any cause, whichever comes first. Progression is defined as followed:① A growth of primary lesion or appearance of neopathy by image diagnosis, aggravation of general condition・PS decrease or noticable weight loss which investigator assess as progression. ②Unmeasurable or difficult to measure lesion which newly appeared or investigator assess as obvious aggravation. ③ In the case of any new chemotherapy added or changed to another treatment to prostate cancer
Time frame: 50 months
TTTF is defined as time from date of initial dose until the date of any new chemotherapy added or changed to another treatment to prostate cancer.
Time frame: 50 months
TTPP is defined as time from date of initial dose until the date of first confirmed PSA progression (an increase in PSA of >= 25% and >= 2 ng/ml above the nadir after initial dose). In the case of any new chemotherapy added or changed to another treatment to prostate cancer, the conducted date will be applied.
Time frame: 50 months
PSA response rate is defined as ratio of patients who have an decrease in PSA of >= 50% above baseline since initial dose.
Time frame: 50 months
TTFS is defined as time from date of initial dose until the date of first confirmed skeletal-related event. In the case of any new chemotherapy added or changed to another treatment to prostate cancer, the conducted date will be applied. Symptomatic Skeletal Events (SSE) defined as followed: ・Operation of EBRT External Beam Radiation Therapy (EBRT) to mitigate skeletal events ・New appearance of symptomatic pathological fracture ・Appearance of spinal cord compression ・Orthopedic intervention related to tumor
Time frame: 2 years
The state of administration is assessed by Relative Dose Intensity (RDI). RDI is calculated by dosage and dosing period. RDI calculation formula =∑ (daily dosage ×dosing days) / (160mg ×total dosing number of days). ∑ means all total dose which adds up in different dosage. Total number of days mean treatment term of this trial.
Time frame: 50 months
Safety assessment by the incidence and severity of adverse events as assessed by Japanese version of the Common Terminology Criteria for Adverse Events (CTCAE) version 4.00
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Other
Acronym: DELC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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