High- or very-high risk, localized or locally advanced prostate cancer MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
Male
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 stage per AJCC 8th Edition, 2) Gleason score 7, PSA >=20 nanogram per mililiters (ng/mL), and >=cT2c stage per AJCC 8th Edition - Charlson comorbidity index (CCI) =65 years) yes F.1.3.1 Number of subjects for this age range 600
Exclusion criteria
Exclusion criteria: - Presence of distant metastasis (clinical stage M1). Isolated pelvic nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Patients are considered eligible only if the central radiological review confirms clinical stage M0. - Prior treatment with GnRH analogue or antiandrogen or both for >3 months prior to randomization - Bilateral orchiectomy - History of pelvic radiation - Prior systemic (eg, chemotherapy) or local (eg, radical prostatectomy, cryotherapy) treatment for prostate cancer - History of seizure or any 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 apalutamide, 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 |
|---|---|
| Main Objective: To determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in subjects with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of metastasis-free survival (MFS) evaluated by blinded independent central review (BICR);Secondary Objective: - To characterize the safety profile of apalutamide plus GnRH agonist in subjects with high-risk, localized or locally advanced prostate cancer receiving primary RT - To determine if apalutamide plus GnRH agonist in subjects with high-risk, localized or locally advanced prostate cancer receiving primary RT results in an improvement of: * Event-free survival * Time to PSA progression * Overall survival (OS) * Time to distant metastasis * Time to next local or systemic treatment * MFS by conventional or positron emission tomography (PET) imaging;Primary end point(s): Metastasis-free survival;Timepoint(s) of evaluation of this end point: approximately 84 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Event-free survival - Time to PSA progression - Overall Survival (OS);Timepoint(s) of evaluation of this end point: approximately 84 months | — |
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Czech Republic, France, Germany, Israel, Italy, Korea, Republic of, Malaysia, Mexico, Netherlands, Poland, Romania, Russian Federation, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV (Janssen Biologics BV)
Outcome results
None listed