Clinical Trials List
Protocol Number56021927PCR3011
NCT Number(ClinicalTrials.gov Identfier)NCT03767244
Active
2019-07-22 - 2026-12-29
Phase III
Recruiting7
ICD-10C61
Malignant neoplasm of prostate
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Who are Candidates for Radical Prostatectomy
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Trial Applicant
Johnson & Johnson
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Sponsor
Janssen Research & Development, LLC
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-Yen Lin Division of Urology
- 吳致瑩 Division of Urology
- Cheng-Che Chen Division of Urology
- Cheng-Kuang Yang Division of Urology
- 盧嘉文 Division of Urology
- Jian-Ri Li Division of Urology
- 林雁婷 Division of Radiology
- Chuan-Shu Chen Division of Urology
- 王樹吉 Division of Urology
- 熊小澐 Division of Radiology
- 夏熠 Division of Others
- 裘坤元 Division of Urology
- 洪晟鈞 Division of Urology
- 洪啟峰 Division of Urology
- 夏熠 Division of Others
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yi-Huei Chang Division of Hematology & Oncology
- Chi-Rei Yang Division of Hematology & Oncology
- 陳冠亨 Division of Hematology & Oncology
- Yu-De Wang Division of Hematology & Oncology
- 謝德鈞 Division of Hematology & Oncology
- Chao-Hsiang Chang Division of Hematology & Oncology
- Han Chang Division of Others -
- Po-Fan Hsieh Division of Hematology & Oncology
- Chi-Ping Huang Division of Hematology & Oncology
- Wei-Ching Lin Division of Hematology & Oncology
- Po-Jen Hsiao Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- - - Division of Radiology
- JIAN-HUA HONG Division of Urology
- PO-MING CHOW Division of Urology
- YU-CHUAN LU Division of Urology
- 王中傑 Division of Others
- YI-KAI CHANG Division of Urology
- CHING-CHU LU Division of Nuclear Medicine
- SHUO-MENG WANG Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ching-Chia Li Division of Urology
- Yung-Chin Lee Division of Urology
- 黃俊農 Division of Urology
- 阮雍順 Division of Urology
- Hsiang Ying Lee Division of Urology
- Sheng-Chen Wen Division of Urology
- Tsu-Ming Chien Division of Urology
- Hung-Lung Ke Division of Urology
- Shu-Pin Huang Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced Prostate Cancer
Objectives
The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) based on conventional imaging, as compared to placebo plus ADT.
Test Drug
Apalutamide (JNJ-56021927)
Active Ingredient
Apalutamide (JNJ-56021927)
Dosage Form
tablets
Dosage
60
Endpoints
Primary Outcome Measures :
Percentage of Participants with Pathologic complete response (pCR) [ Time Frame: Approximately 4 years ]
pCR is assessed by a pathology blinded independent central radiology review (BICR) as defined in the pathology charter.
Metastasis-Free Survival (MFS) [ Time Frame: Approximately 8 years ]
MFS is defined as the time from randomization to the date of the first occurrence of radiographic distant metastasis on conventional imaging [that is, computed tomography (CT)/magnetic resonance imaging (MRI) and bone scan]) evaluated by radiology BICR, incidental pathologic finding of distant metastasis, or death from any cause, whichever occurs first.
Secondary Outcome Measures :
Prostate Specific Antigen (PSA)-Free Survival [ Time Frame: Approximately 4 years ]
PSA-free survival with testosterone recovery defined as the time from randomization to the first detectable serum PSA level with recovered testosterone levels after undetectable PSA post-radical prostatectomy with pelvic lymph node dissection or death, whichever occurs first.
Progression-Free Survival (PFS) [ Time Frame: Approximately 8 years ]
PFS is defined as the time from randomization to first documentation of BICR confirmed radiographic progressive disease or death due to any cause (whichever occurs first) plus 1 day. Progressive disease will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. As per RECIST v1.1. Unequivocal local-regional progression/recurrence or the distant metastasis observed on CT or MRI scans or identified by biopsy will be considered progression. Local-regional progression/recurrence is defined as local tumor recurrence in the prostate bed or occurrence of at least one new regional lymph node.
Number of Participants with Adverse Events [ Time Frame: Up to 30 days after last dose of study drug (Approximately 8 years) ]
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Number of Participants with Laboratory Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Up to 30 days after last dose of study drug (Approximately 8 years) ]
Blood samples for serum chemistry and hematology will be collected at predefined time points for clinical laboratory testing.
Number of Participants with Vital Signs Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Up to 30 days after last dose of study drug (Approximately 8 years) ]
Number of participants with vital signs (including body temperature, heart rate, respiratory rate, and blood pressure) abnormalities will be reported.
Number of Participants with Physical Examinations Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Up to 30 days after last dose of study drug (Approximately 8 years) ]
Number of participants with physical examinations (including general appearance of the subject, height, weight, and examination of the skin, ears, nose, throat, lungs, heart, abdomen, extremities, musculoskeletal system, lymphatic system, and nervous system) abnormalities will be reported.
Number of Participants with Treatment Compliance Rate [ Time Frame: Up to 30 days after last dose of study drug (Approximately 8 years) ]
Number of participants who are complaint with study treatment will be assessed.
Percentage of Participants with Pathologic complete response (pCR) [ Time Frame: Approximately 4 years ]
pCR is assessed by a pathology blinded independent central radiology review (BICR) as defined in the pathology charter.
Metastasis-Free Survival (MFS) [ Time Frame: Approximately 8 years ]
MFS is defined as the time from randomization to the date of the first occurrence of radiographic distant metastasis on conventional imaging [that is, computed tomography (CT)/magnetic resonance imaging (MRI) and bone scan]) evaluated by radiology BICR, incidental pathologic finding of distant metastasis, or death from any cause, whichever occurs first.
Secondary Outcome Measures :
Prostate Specific Antigen (PSA)-Free Survival [ Time Frame: Approximately 4 years ]
PSA-free survival with testosterone recovery defined as the time from randomization to the first detectable serum PSA level with recovered testosterone levels after undetectable PSA post-radical prostatectomy with pelvic lymph node dissection or death, whichever occurs first.
Progression-Free Survival (PFS) [ Time Frame: Approximately 8 years ]
PFS is defined as the time from randomization to first documentation of BICR confirmed radiographic progressive disease or death due to any cause (whichever occurs first) plus 1 day. Progressive disease will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. As per RECIST v1.1. Unequivocal local-regional progression/recurrence or the distant metastasis observed on CT or MRI scans or identified by biopsy will be considered progression. Local-regional progression/recurrence is defined as local tumor recurrence in the prostate bed or occurrence of at least one new regional lymph node.
Number of Participants with Adverse Events [ Time Frame: Up to 30 days after last dose of study drug (Approximately 8 years) ]
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Number of Participants with Laboratory Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Up to 30 days after last dose of study drug (Approximately 8 years) ]
Blood samples for serum chemistry and hematology will be collected at predefined time points for clinical laboratory testing.
Number of Participants with Vital Signs Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Up to 30 days after last dose of study drug (Approximately 8 years) ]
Number of participants with vital signs (including body temperature, heart rate, respiratory rate, and blood pressure) abnormalities will be reported.
Number of Participants with Physical Examinations Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Up to 30 days after last dose of study drug (Approximately 8 years) ]
Number of participants with physical examinations (including general appearance of the subject, height, weight, and examination of the skin, ears, nose, throat, lungs, heart, abdomen, extremities, musculoskeletal system, lymphatic system, and nervous system) abnormalities will be reported.
Number of Participants with Treatment Compliance Rate [ Time Frame: Up to 30 days after last dose of study drug (Approximately 8 years) ]
Number of participants who are complaint with study treatment will be assessed.
Inclution Criteria
Inclusion Criteria:
Histologically confirmed adenocarcinoma of the prostate
High-risk disease defined by a total Gleason Sum Score greater than equal to (>=) 4+3 (=Grade Groups [GG] 3 5) and >=1 of the following 4 criteria: a) Any combination of Gleason Score 4+3 (= 3) and Gleason Score 8 (4+4 or 5+3) in >= 6 systematic cores (with >=1 core Gleason Score 8 [4+4 or 5+3] included); b) Any combination of Gleason Score 4+3 (=GG 3) and Gleason Score 8 (4+4 or 5+3) in >=3 systematic cores and Prostate-specific antigen (PSA) >=20 ng/mL (with >= 1 core Gleason Score 8 [4+4 or 5+3] included); c) Gleason Score >=9 (=GG 5) in at least 1 systematic or targeted core; d) At least 2 systematic or targeted cores with continuous Gleason Score >=8 (=GG 4), each with > 80 percent (%) involvement
Candidate for radical prostatectomy with pelvic lymph node dissection as per the investigator
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Contraceptive use by men and female partners of men enrolled in the study who are of childbearing potential or are pregnant) should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
Able to receive androgen deprivation therapy (ADT) for at least 13 months
Histologically confirmed adenocarcinoma of the prostate
High-risk disease defined by a total Gleason Sum Score greater than equal to (>=) 4+3 (=Grade Groups [GG] 3 5) and >=1 of the following 4 criteria: a) Any combination of Gleason Score 4+3 (= 3) and Gleason Score 8 (4+4 or 5+3) in >= 6 systematic cores (with >=1 core Gleason Score 8 [4+4 or 5+3] included); b) Any combination of Gleason Score 4+3 (=GG 3) and Gleason Score 8 (4+4 or 5+3) in >=3 systematic cores and Prostate-specific antigen (PSA) >=20 ng/mL (with >= 1 core Gleason Score 8 [4+4 or 5+3] included); c) Gleason Score >=9 (=GG 5) in at least 1 systematic or targeted core; d) At least 2 systematic or targeted cores with continuous Gleason Score >=8 (=GG 4), each with > 80 percent (%) involvement
Candidate for radical prostatectomy with pelvic lymph node dissection as per the investigator
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Contraceptive use by men and female partners of men enrolled in the study who are of childbearing potential or are pregnant) should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
Able to receive androgen deprivation therapy (ADT) for at least 13 months
Exclusion Criteria
Exclusion Criteria:
Distant metastasis based on conventional imaging (clinical stage M1). 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. Participants are considered eligible only if the central radiological review confirms clinical stage M0
(a) Prior treatment with androgen receptor antagonists; (b) Treatment with gonadotropin-releasing hormone analog (GnRHa) prior to informed consent form (ICF) signature
History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer
Use of any investigational agent less than or equals to (<=)4 weeks prior to randomization or any therapeutic procedure for prostate cancer at any time
Major surgery <=4 weeks prior to randomization
Any of the following within 12 months prior to first dose of study drug: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (example, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary
Distant metastasis based on conventional imaging (clinical stage M1). 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. Participants are considered eligible only if the central radiological review confirms clinical stage M0
(a) Prior treatment with androgen receptor antagonists; (b) Treatment with gonadotropin-releasing hormone analog (GnRHa) prior to informed consent form (ICF) signature
History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer
Use of any investigational agent less than or equals to (<=)4 weeks prior to randomization or any therapeutic procedure for prostate cancer at any time
Major surgery <=4 weeks prior to randomization
Any of the following within 12 months prior to first dose of study drug: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (example, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary
The Estimated Number of Participants
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Taiwan
110 participants
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Global
2400 participants
