Prostatic Neoplasms
Conditions
Interventions
investigational material(s)
Generic name etc : Apalutamide
INN of investigational material : Apalutamide
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigat
Sponsors
Janssen Pharmaceutical K.K.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - 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 PSA according to the Prostate Cancer Clinical Trials Working Group (PCWG2) or radiographic progression of soft tissue 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 - Participants who cross-over from Prednisone alone to open-label apalutamide plus AAP should still be in the double-blind phase of the study, should be receiving AAP alone and should have ECOG 0-1-2.
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 non-herbal 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 |
|---|---|
| efficacy Radiographic Progression-free Survival (rPFS) Time from randomization until death or lost to follow-up or withdrawal of consent or study termination, whichever occurs first, up to 5 years Radiographic progression of bone is determined if there are more than or equal (>=) to 2 new lesions if less than (= 2 new lesions after more than 12 weeks from randomization and the same is confirmed 6 weeks later or, progression of soft tissue lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Overall Survival(OS) Time from randomization until death or lost to follow-up or withdrawal of consent or study termination, whichever occurs first, up to 5 years The OS is defined as the time from randomization to date of death from any cause. efficacy Time to Chronic Opioid Use Baseline up to 5 years Time to chronic opioid use is defined as the time from date of randomization to the first date of opioid use. efficacy Time to Initiation of Cytotoxic Chemotherapy Baseline up to 5 years Time to initiation of cytotoxic chemotherapy is defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy. efficacy Time to Pain Progression Baseline up to 5 years Time to pain progression is defined as time from randomization to progression in worst pain over the last 24 hours (item 3) in the Brief pain inventory-short form (BPI-SF). BPI-SF is a self-evaluated pain assessment form consisting of 15 items. The Worst Pain-item 3 of the BPI-SF scale is used to assess pain on 11-point Likert scale which has range: 0 (no pain) to 10 (pain as bad as you can imagine). | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South Africa, South America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed