A study of apalutamide in metastatic castration-resistant prostate cancer patients

JRCT ID: jRCTs051220077

Registered date:16/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Metastatic Castration-resistant Prostate Cancer
• Date of first enrollment: 05/09/2022
• Target sample size: 110
• Study type: Interventional
• Intervention(s): The dose of apalutamide is 240 mg administered orally once daily.

Outcome(s)

• Primary Outcome: PSA response rate, defined as >= 50% decline in PSA from baseline at 12 weeks

Secondary Outcome

(1) Time to PSA progression
(2) Progression free survival (PFS)
(3) Overall survival (OS)
(4) Progression free survival during second therapy (PFS2)
(5) >= 50% decline in PSA from baseline at 24 and 48 weeks
(6) >= 90% decline in PSA from baseline at 12, 24 and 48 weeks or the achievement below detection limit after the initial dose
(7) PSA maximal changes
(8) Accumulated PSA response from the screening to 24 and 48 weeks
(9) Grade 3 or grater adverse events graded with CTCAE (v4)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

(1) Patients who have histologically significant adenocarcinoma
(2) Patients who have 1 or more distant metastases
(3) Patients who received any one of the following treatments for hormone-sensitive cancer
-Androgen ablative therapy including combined androgen blockade therapy
-Combination therapy with androgen ablative therapy and abiraterone
-Combination therapy with androgen ablative therapy and docetaxel
(4) Patients who were diagnosed as mCRPC, based on at least 1 of the following criteria, in castrate level of blood testosterone < 50 ng/dL after androgen ablative therapy
-PSA level >= 1 ng/mL that has increased on 2 successive occasions at least 1 week apart
-Appearance of 2 or more new lesions in bone
-Nodal or visceral metastases as defined by RECIST 1.1 with PCGW3 modifications
(5) Laboratory requirements within 2 months before enrollment
AST <= 100 U/L, ALT <= 100 U/L, Serum creatinine <= 2.00 mg/dL
(6) ECOG Performance Status 0-2
(7) 20 years or over patients
(8) Patients who provided informed consent for participation in this study

Exclude criteria

(1) Patients who have histologically significant neuroendocrine differentiation or small cell
(2) Patients who have received apalutamide, enzalutamide or darolutamide for metastatic prostate cancer or non-mCRPC
(3) Patients who received local therapy (total prostatectomy or definitive radiotherapy) within 1 year before enrollement
(4) Patients with serious viral active infection
(5) Patients who have a history of malignant tumors considered not cured other than prostate cancer
(6) Patients suffering from other severe acute or chronic diseases
(7) Patients complicated with psychiatric disordersor symptoms and considered difficult to participate in this study
(8) Patients found to be intolerable to components of test drug (or excipients)
(9) For other reasons, patients who are cosidered inappropriate for participation in this study at physician's discretion

Related Information

• Primary Sponsor: Nakano Yuzo
• Source(s) of Monetary Support: Janssen Pharmaceutical K.K.,Janssen Pharmaceutical K.K.