Apalutamide for Metastatic castration-resistant prostate cancer

Inclusion criteria

• {"criterion_text":"- Subject must be a man age ≥18 years of age, inclusive\n- Adenocarcinoma of the prostate\n- 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\n- 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)\n- Patients 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\n- 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 Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST) modified based on PCWG2, or radiographic progression of bone according to PCWG2."}

Exclusion criteria

• {"criterion_text":"- Small cell or neuroendocrine carcinoma of the prostate\n- Known brain metastases\n- Prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting\n- Previously treated with ketoconazole for prostate cancer for greater than 7 days\n- 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\n- At screening need for parenteral or oral opioid analgesics (eg, codeine, dextropropoxyphene)"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is radiographic progression-free survival (rPFS).","definition_or_measurement_approach":"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 endpoints

• {"endpoint_text":"- Overall survival (OS) is defined as the time from date of randomization to date of death from any cause.","definition_or_measurement_approach":"Overall survival (OS) is defined as the time from date of randomization to date of death from any cause."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"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."}
• {"endpoint_text":"- Time to initiation of cytotoxic chemotherapy is defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy","definition_or_measurement_approach":"Time to initiation of cytotoxic chemotherapy is defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Time to pain progression is defined as the time from date of randomization to the first date a subject experiences 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."}

Netherlands

Earliest CTIS Part Ii Submission Date

25-01-2024

Latest Decision Or Authorization Date

24-06-2025

Processing Time Days

516

Number Of Sites

10

Number Of Participants

1

Spain

Earliest CTIS Part Ii Submission Date

25-01-2024

Latest Decision Or Authorization Date

24-06-2025

Processing Time Days

516

Number Of Sites

1

Number Of Participants

2

Germany

Earliest CTIS Part Ii Submission Date

25-01-2024

Latest Decision Or Authorization Date

27-06-2025

Processing Time Days

519

Number Of Sites

2

Number Of Participants

2

Primary sponsor

Full Name

Janssen Cilag International

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

Expert Brand Solutions Limited

Responsibilities

Drug Destruction

Name

Perceptive Eclinical Limited

Responsibilities

Clinical IP Supply Management

Third parties

• {"country":"United Kingdom","full_name":"Expert Brand Solutions Limited","duties_or_roles":"Drug Destruction","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"Clinical IP Supply Management","organisation_type":"Pharmaceutical company"}