Prostate Cancer
Conditions
Interventions
JNJ-56021927 240 mg group (4 tablets of 60 mg)
500 participants
administered once daily orally with or without food
Placebo group(4 tablets)
500 participantes
All participants will receive and remain on a stable regimen of ADT (gonadotropin releasing hormone analog [GnRHa] or surgical castration).
Drug
D06.472.699.327.740.320
Sponsors
Fundação Pio XII - Hospital de Câncer de Barretos
Janssen-Cilag Farmacêutica Ltda.
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adenocarcinoma of prostate; if diagnosed greater than or equal to (>=) 5 years from randomization; Metastatic disease documented by >= 2 bone lesions on 99mTc bone scan; Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0, 1, or 2; Allowed prior treatment for prostate cancer: a) Maximum of 1 course of radiation or surgical intervention; b) Up to 6 cycles of docetaxel for low-volume disease with the last dose within 2 months of randomization; c) Must not have experienced disease progression between the last dose of docetaxel and Screening; Participants who did not receive prior docetaxel may have received less than or equal to ()1 year prior to randomization; May have received radiation therapy or prostatectomy as definitive therapy
Exclusion criteria
Exclusion criteria: Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate - Known brain metastases - Lymph nodes as only site of metastasis – Visceral metastasis observed on computed tomography (CT)/magnetic resonance imaging (MRI) or >= 4 bone lesions on 99mTc bone scan with at least 1 lesion beyond the pelvis or vertebral column - Any prior malignancy within 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer - Prior treatment with other second generation anti-androgens or other CYP17 inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer - History of seizures or medications known to lower seizure threshold
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic Progression-Free Survival (rPFS); up to 76 months; The rPFS is defined as the duration from the date of randomization to the date of first documentation of radiographic progressive disease or death due to any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS); Up to 76 Months ; The OS is defined as the time from date of randomization to date of death from any cause;Time to Skeletal-Related Event (SRE); Up to 76 Months; Time to SRE is defined as the time from the date of randomization to the date of the first occurrence of a fracture or treatment for the fracture. The SRE is defined as the occurrence of either pathological or clinical fracture, spinal cord compression, radiation to bone, or surgery to bone.;Time to Chronic Opioid Use; Up to 76 Months; Time to chronic opioid use is defined as the time from date of randomization to the first date of opioid use or first date of an increase in the total daily dose.;Time to Initiation of Cytotoxic Chemotherapy; Up to 76 Months; Time to initiation of cytotoxic chemotherapy is defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy.;Time to Pain Progression; Up to 76 Months; Time to pain progression is defined as the time from the date of randomization to the date of the first observation of pain progression | — |
Countries
Argentina, Australia, Brazil, Canada, Czech Republic, Democratic Republic Lau, France, Germany, Mexico, Romania, Spain, Turkey, Ukraine, United Kingdom
Contacts
Public ContactVinicius Righi
Janssen-Cilag Farmacêutica Ltda.
Outcome results
None listed