Advanced Prostate Cancer
Conditions
Interventions
JNJ-56021927 group: 750 Participants will receive JNJ- 56021927 (240 mg) daily, by mouth for 28 months plus bicalutamide placebo by mouth, once daily, for four months from randomization. All participa
750 participants: Participants will receive bicalutamide 50 mg, by mouth, once daily, for 4 months plus JNJ-56021927 placebo once daily for 28 months from randomization. All participants are treated w
Drug
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: Inclusion Criteria:Age >= 18 years; Indicated and planned to receive primary radiation therapy for prostate cancer; Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis: 1) Gleason score >=8 and >=cT2c, 2) Gleason score >=7, PSA >=20 nanogram per mililiters (ng/mL), and >=cT2c; Charlson comorbidity index (CCI) <=3 - An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1; Adequate liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), <2 * upper limit of normal (ULN) and total bilirubin <1.5 * ULN - Participants who are sexually active (even men with vasectomies) and willing to use a condom and agree not to donate sperm during the trial ; Signed, written, informed consent; Be able to swallow whole study drug tablets
Exclusion criteria
Exclusion criteria: Exclusion Criteria:Presence of distant metastasis, including pelvic nodal disease below the iliac bifurcation >2 cm in the short axis - Prior treatment with GnRH analogue or anti-androgen or both for >3 months prior to randomization - Bilateral orchiectomy ; History of pelvic radiation; Prior systemic (eg, chemotherapy) or procedural (eg, prostatectomy, cryotherapy) treatment for prostate cancer; History of seizure or condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness =3 weeks for oral or >7 days for non-oral formulations; Major surgery <=4 weeks prior to randomization; Current or prior treatment with antiepileptic medications for the treatment of seizures; Gastrointestinal conditions affecting absorption; Known or suspected contraindications or hypersensitivity to JNJ-56021927, bicalutamide or GnRH agonists or any of the components of the formulations - Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metastasis-free survival - Metastasis-free survival is defined as the time from randomization to the date of the first occurrence of radiographic bone metastasis or distant metastasis to soft tissue by BICR, eventual pathological distant metastasis or death from any cause found, whichever comes first. | — |
Secondary
| Measure | Time frame |
|---|---|
| The time to locoregional recurrence; defined as the time from randomization to the date of local or regional recurrence of disease, defined as one or more of the following: - Increase> 50% in volume of the prostate compared to the smaller volume per test image ;Sensing a new palpable pelvic injury in the case of clinical standards previously completed ;identification of a new regional lymph node biopsy or examination of image-recurrence in prostate gland biopsy confirmed; ;Time until CRPC; Defined as the time from randomization to the date when the last of the three increases in PSA collected with at least one month interval exceeds 2 ng / mL above the nadir or evidence of new clinical disease, while the participant research present castrate levels of testosterone (<50 ng / dl), is receiving medical treatment or castration has been subjected to an orchiectomy; ;Time to distant metastasis; defined as the time from randomization to the date of the first occurrence of radiographic bone metastasis or distant metastasis to soft tissue by BICR.; ;Overall Survival (OS); Defined as the time from randomization to the date of death from any cause | — |
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Poland, Republic of Korea, Romania, Russian Federation, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactVinicius Righi
Janssen-Cilag Farmacêutica Ltda.
Outcome results
None listed