Status:
ACTIVE_NOT_RECRUITING
A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC)
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the improvement in time to prostate specific antigen (PSA) progression (TTPP, as defined by Prostate Cancer Working Group 2 \[PCWG2\]) of apalutamide versus pla...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features, with high risk for development of metastases, defined as prostate-specific antigen doubling time (PSADT) less than or equals to (\<=) 10 months. PSADT is calculated using at least 3 prostate-specific antigen (PSA) values obtained during continuous androgen deprivation therapy (ADT)
- Castration-resistant prostate cancer (PC) demonstrated during continuous ADT, defined as 3 PSA rises at least 1 week apart, with the last PSA greater than (\>) 2 nanogram per milliliter (ng/mL)
- Surgically or medically castrated, with testosterone levels of less than (\<) 50 nanogram per deciliter (ng/dL). If the participant is medically castrated, continuous dosing with gonadotropin releasing hormone analog (GnRHa) must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study to maintain castrate levels of testosterone
- Participants who received a first-generation anti-androgen (example: bicalutamide, flutamide, nilutamide) must have at least a 4-week washout prior to randomization and must show continuing disease progression (an increase in PSA) after washout
- At least 4 weeks must have elapsed from major surgery or radiation therapy prior to randomization
Exclusion
- Presence of distant metastases, including central nervous system (CNS) and vertebral or meningeal involvement, or history of distant metastases. Exception: Pelvic lymph nodes \<2 centimeter in short axis (N1) located below the iliac bifurcation are allowed
- Symptomatic loco-regional disease requiring medical intervention, such as moderate or severe urinary obstruction or hydronephrosis, due to primary tumor (example, tumor obstruction of bladder trigone)
- Prior treatment with cytochrome P450 17 alpha-hydroxylase/17,20-lyase (CYP17) inhibitors (example: abiraterone acetate, orteronel, galerterone, ketoconazole, aminoglutethimide) for PC
- Prior chemotherapy for PC, except if administered in the adjuvant/neoadjuvant setting
- Prior treatment with second generation anti-androgens (example, enzalutamide)
- History of seizure or condition that may pre-dispose to seizure (example: prior stroke within 1 year prior to randomization, brain arteriovenous malformation, schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
Key Trial Info
Start Date :
December 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04108208
Start Date
December 17 2019
End Date
June 5 2026
Last Update
December 18 2025
Active Locations (27)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China, 100021
2
Peking University First Hospital
Beijing, China, 100034
3
Peking University People s Hospital
Beijing, China, 100044
4
Beijing Friendship Hospital
Beijing, China, 100050