Clinical Trials List
2015-12-01 - 2028-12-29
Phase III
Terminated6
ICD-10C61
Malignant neoplasm of prostate
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects with High risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment with Primary Radiation Therapy
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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
Co-Principal Investigator
- Yen-Hwa Chang Division of Urology
- 沈書慧 Division of Urology
- Hsiao-Jen Chung Division of Urology
- Yu-Ming Liu Division of Radiation Therapy
- Yi-Hsiu Huang Division of Urology
- Tzu-Ping Lin Division of Urology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Wen-Chi Chen Division of Urology
- Chao-Hsiang Chang Division of Urology
- 賴宥良 Division of Urology
- 陳冠亨 Division of Urology
- Chin-Chung Yeh Division of Urology
- Chi-Rei Yang Division of Urology
- Chi-Shun Lien Division of Urology
- Ji-An Liang Division of Radiation Therapy
- Chi-Ping Huang Division of Urology
- Yi-Huei Chang Division of Radiation Therapy
- Po-Fan Hsieh Division of Urology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 吳東霖 Division of Urology
- 黃偉倫 Division of Urology
- Chun-Chieh Wang Division of Urology
- 張國楨 Division of Urology
- 林仁泰 Division of Urology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 黃冠勳 Division of Urology
- Che-Yuan Hu Division of Urology
- 薛尉廷 Division of Radiation Therapy
- Jiann-Hui Ou Division of Urology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Rita cheng Division of Hematology & Oncology
- 范綱行 Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
7 Stop recruiting
Audit
None
Co-Principal Investigator
- CHUNG-HSIN CHEN Division of Urology
- - - Division of Urology
- 劉詩彬 Division of Urology
- CHING-CHU LU Division of Urology
- Yeong-Shiau Pu Division of Urology
- 王嘉儁 Division of Radiation Therapy
- Chia-Hsien Chen Division of Radiation Therapy
- 藍耿學 Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
1. Metastasis-free survival [ Time Frame: 84 Months ]
Secondary Outcome Measures :
1. Time to Local-regional Recurrence [ Time Frame: 84 Months ]
2. Time to Castration-resistant Prostate Cancer (CRPC) [ Time Frame: 84 Months ]
3. Time to Distant Metastasis [ Time Frame: 84 Months ]
4. Overall Survival (OS) [ Time Frame: 84 Months ]
Inclution Criteria
Each potential subject must satisfy all of the following criteria to be enrolled in the study.
1. Subject must be a man ≥18 years of age
2. Each subject must sign an informed consent form (ICF) indicating that he understands
the purpose of and procedures required for the study and is willing to participate in the
study. Subjects must be willing and able to adhere to the prohibitions and restrictions
specified in this protocol (Section 4.3).
3. Indicated and planned to receive primary RT for prostate cancer.
4. Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following
at diagnosis:
Gleason score ≥8 and ≥cT2c
Gleason score ≥7, PSA ≥20 ng/mL, and ≥cT2c
5. Charlson comorbidity index (CCI) ≤3 (Attachment 1)
6. An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0
or 1 (Attachment 2)
7. Adequate liver function determined by the following central laboratory values:
aspartate aminotransferase (AST), alanine aminotransferase (ALT), <2 x upper
limit of normal (ULN) and
total bilirubin <1.5 x upper limit of normal (ULN) [NOTE: in subjects with
Gilbert’s syndrome, if total bilirubin is >1.5 x ULN, measure direct and indirect
bilirubin and if direct bilirubin is ≤1.5 x ULN, subject may be eligible]
8. To avoid risk of drug exposure through the ejaculate (even men with vasectomies),
subjects must use a condom during sexual activity while on study drug and for
3 months following the last dose of study drug. Donation of sperm is not allowed
during the Treatment Phase and for 3 months following the last dose of study drug.
9. Be able to swallow whole study drug tablets
Exclusion Criteria
Each potential subject must NOT satisfy any of the following criteria to be enrolled in the study.
1. Presence of distant metastasis, including pelvic nodal disease below the iliac bifurcation
>2 cm in the short axis
2. Prior treatment with GnRH analogue or anti-androgen or both for >3 months prior to
randomization
3. Bilateral orchiectomy
4. History of pelvic radiation
5. Prior systemic (eg, chemotherapy) or procedural (eg, prostatectomy, cryotherapy)
treatment for prostate cancer
6. Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone,
ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational
agents for prostate cancer
7. Prior treatment with radiopharmaceutical agents (eg, strontium-89) or immunotherapy
(eg, sipuleucel-T) for prostate cancer
8. Prior treatment with systemic glucocorticoids ≤4 weeks prior to randomization or is
expected to require long-term use of corticosteroids during the study
9. Use of 5-α reductase inhibitors (eg, dutasteride, finasteride) ≤4 weeks prior to
randomization
10. Use of any investigational agent ≤4 weeks prior to randomization
11. Current chronic use of opioid analgesics for ≥3 weeks for oral or ≥7 days for non-oral
formulations
12. Major surgery ≤4 weeks prior to randomization
13. History of seizure or condition that may predispose to seizure (including, but not limited
to prior stroke, transient ischemic attack or loss of consciousness ≤1 year prior to
randomization; brain arteriovenous malformation; or intracranial masses such as
schwannomas and meningiomas that are causing edema or mass effect).
14. Current or prior treatment with anti-epileptic medications for the treatment of seizures
15. Gastrointestinal conditions affecting absorption
16. Known or suspected contraindications or hypersensitivity to JNJ-56021927,
bicalutamide or GnRH agonists or any of the components of the formulations
17. Any condition for which, in the opinion of the investigator, participation would not be
in the best interest of the subject
The Estimated Number of Participants
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Taiwan
42 participants
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Global
1500 participants
