Metastatic castration-resistant prostate cancer (mCRPC) MedDRA version: 21.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic 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: - Subject must be a man age =18 years of age, inclusive - Adenocarcinoma of the prostate - Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). If lymph node metastasis is the only evidence of metastasis, it must be greater than or equal to (>=) 2 centimeter (cm) in the longest diameter - Castration-resistant prostate cancer demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of PSA, at least 1 week apart with the last androgen deprivation therapy (PSA) >= 2 nanogram per milliliters (ng/mL) - Participants who received a first generation anti-androgen (eg, bicalutamide, flutamide, nilutamide) must have at least a 6-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after the washout period - Prostate cancer progression documented by prostate-specific antigen (PSA)according to the Prostate Cancer Clinical Trials Working Group (PCWG2)radiographic progression of soft tissues according to modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST) modified based on PCWG2, or radiographic progression of bone according to PCWG2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 96 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 864
Exclusion criteria
Exclusion criteria: - Small cell or neuroendocrine carcinoma of the prostate - Known brain metastases - Prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting - Previously treated with ketoconazole for prostate cancer for greater than 7 days - Therapies that must be discontinued or substituted at least 4 weeks prior to randomization include the following: a) Medications known to lower the seizure threshold, b) Herbal and nonherbal products that may decrease PSA levels (example [eg], saw palmetto, pomegranate) or c) Any investigational agent - At screening need for parenteral or oral opioid analgesics (eg, codeine, dextropropoxyphene)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the radiographic progression-free survival(rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in subjects with chemotherapy-naïve mCRPC. ;Secondary Objective: 1. To characterize the safety profile of apalutamide in combination with AAP 2. To characterize the pharmacokinetics (PK) of apalutamide and abiraterone;Primary end point(s): The primary endpoint is radiographic progression-free survival (rPFS).;Timepoint(s) of evaluation of this end point: Radiographic progression will be assessed by Bone scan and CT/MRI scan. Bone scan will be performed within 6 weeks of randomisation. CT/MRI will be performed within 42 days of randomisation. Both Bone scans and CT/MRI will be performed on Day 1 of cycle 3, Day 1 of cycle 5 then every 3 subsequent cycles beginning at cycle 7 including EOT visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall survival (OS) is defined as the time from date of randomization to date of death from any cause. 2. Time to chronic opioid use (oral opioid use for =3 weeks; parenteral opioid use for =7 days) is defined as the time from date of randomization to the first date of opioid use 3. Time to initiation of cytotoxic chemotherapy is defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy 4. Time to pain progression defined as the time from date of randomization to the first date a subject experience an increase by 2 points from baseline in the BPI-SF worst pain intensity item 3 observed at 2 consecutive evaluations =4 weeks apart or initiation of chronic opioids, whichever occurs first;Timepoint(s) of evaluation of this end point: Endpoints 1.,2., 3. and 4 will be evaluated at EOT visit and every 3 months during the follow up phase. For Endpoint 4 the BPI-SF will be performed consecutively for 7 days starting 6 days before Day 1 of each cycle including the EOT visit and every 3 months for up to 12 months after treatment discontinuation during the follow up phase | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, France, Germany, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Russian Federation, South Africa, Spain, United Kingdom, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV (Janssen Biologics BV)
Outcome results
None listed