An Efficacy and Safety Study of JNJ- 56021927 (ARN-509) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-76cwjd
• Date of registration: 30/03/2016
• Prospective Registration: No
• Primary sponsor: Fundação Pio XII - Hospital de Câncer de Barretos
• Public title: An Efficacy and Safety Study of JNJ- 56021927 (ARN-509) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy
• Scientific title: 56021927PCR3003 - A Randomized, Double-blind, Placebocontrolled Phase 3 Study of JNJ- 56021927 in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment with Primary Radiation Therapy
• Date of first enrolment: 15/12/2015
• Recruitment status: Not yet recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-76cwjd
• Study type: Intervention
• Study design: Clinical study, parallel, 2-arm, double-blind, randomized controlled, phase 3, prospective
• Phase: 3

Countries of recruitment

Argentina, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Poland, Republic of Korea, Romania, Russian Federation, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: Flavio Mavignier Carcano
• Affiliation: Fundação Pio XII - Hospital de Câncer de Barretos

• Name: Vinicius Righi
• Affiliation: Janssen-Cilag Farmacêutica Ltda.

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion Criteria:Age >= 18 years; Indicated and planned to receive primary radiation therapy for prostate cancer; Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis: 1) Gleason score >=8 and >=cT2c, 2) Gleason score >=7, PSA >=20 nanogram per mililiters (ng/mL), and >=cT2c; Charlson comorbidity index (CCI) <=3 - An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1; Adequate liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), <2 * upper limit of normal (ULN) and total bilirubin <1.5 * ULN - Participants who are sexually active (even men with vasectomies) and willing to use a condom and agree not to donate sperm during the trial ; Signed, written, informed consent; Be able to swallow whole study drug tablets
Exclusion criteria: Exclusion Criteria:Presence of distant metastasis, including pelvic nodal disease below the iliac bifurcation >2 cm in the short axis - Prior treatment with GnRH analogue or anti-androgen or both for >3 months prior to randomization - Bilateral orchiectomy
; History of pelvic radiation; Prior systemic (eg, chemotherapy) or procedural (eg, prostatectomy, cryotherapy) treatment for prostate cancer; 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); Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents for prostate cancer; Prior treatment with radiopharmaceutical agents (eg, strontium-89) or immunotherapy (eg, sipuleucel-T) for prostate cancer; Prior treatment with systemic glucocorticoids ?4 weeks prior to randomization or is expected to require long-term use of corticosteroids during the study; Use of 5-alpha reductase inhibitors (eg, dutasteride, finasteride) <=4 weeks prior to randomization; Use of any investigational agent <=4 weeks prior to randomization; Current chronic use of opioid analgesics for >=3 weeks for oral or >7 days for non-oral formulations; Major surgery <=4 weeks prior to randomization; Current or prior treatment with antiepileptic medications for the treatment of seizures; Gastrointestinal conditions affecting absorption; Known or suspected contraindications or hypersensitivity to JNJ-56021927, bicalutamide or GnRH agonists or any of the components of the formulations - Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject.

Age minimum: 18Y
Age maximum:
Gender: M

Health Condition(s) or Problem(s) studied

Advanced Prostate Cancer; Prostatic Neoplasms; Malignant neoplasm of prostate

C04.588.945.440.770

Intervention(s)

JNJ-56021927 group: 750 Participants will receive JNJ- 56021927 (240 mg) daily, by mouth for 28 months plus bicalutamide placebo by mouth, once daily, for four months from randomization. All participants are treated with gonadotropin releasing hormone (GnRH - agonist) for 28 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.
Control group; 750 participants: Participants will receive bicalutamide 50 mg, by mouth, once daily, for 4 months plus JNJ-56021927 placebo once daily for 28 months from randomization. All participants are treated with GnRH (agonist) for 28 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.

D06.347.065

Drug

Primary Outcome(s)

Metastasis-free survival - Metastasis-free survival is defined as the time from randomization to the date of the first occurrence of radiographic bone metastasis or distant metastasis to soft tissue by BICR, eventual pathological distant metastasis or death from any cause found, whichever comes first.

Secondary Outcome(s)

The time to locoregional recurrence; defined as the time from randomization to the date of local or regional recurrence of disease, defined as one or more of the following: - Increase> 50% in volume of the prostate compared to the smaller volume per test image

Overall Survival (OS); Defined as the time from randomization to the date of death from any cause

Time until CRPC; Defined as the time from randomization to the date when the last of the three increases in PSA collected with at least one month interval exceeds 2 ng / mL above the nadir or evidence of new clinical disease, while the participant research present castrate levels of testosterone (<50 ng / dl), is receiving medical treatment or castration has been subjected to an orchiectomy;

identification of a new regional lymph node biopsy or examination of image-recurrence in prostate gland biopsy confirmed;

Sensing a new palpable pelvic injury in the case of clinical standards previously completed

Time to distant metastasis; defined as the time from randomization to the date of the first occurrence of radiographic bone metastasis or distant metastasis to soft tissue by BICR.;

Source(s) of Monetary Support

Janssen-Cilag Farmacêutica Ltda.

Secondary Sponsor(s)

Janssen-Cilag Farmacêutica Ltda.