An Efficacy and Safety Study of JNJ56021927 (ARN509) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS

• Register: EUCTR
• Last refreshed on: 22 December 2015
• Main ID: EUCTR2015-003007-38-ES
• Date of registration: 05/11/2015
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International NV
• Public title: An Efficacy and Safety Study of JNJ56021927 (ARN509) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
• Scientific title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ56021927 in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment with Primary Radiation Therapy
• Date of first enrolment: 09/12/2015
• Target sample size: 1500
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003007-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

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

Contacts

• Name: Global Clinical Operations Spain
• Affiliation: Janssen-Cilag, S.A.

• Name: Global Clinical Operations Spain
• Affiliation: Janssen-Cilag, S.A.

Key inclusion & exclusion 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1470
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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 antiandrogen 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:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Low-volume Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
MedDRA version: 18.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Code: JNJ-56021927
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not assigned
CAS Number: 956104-40-8
Current Sponsor code: JNJ-56021927
Other descriptive name: JNJ-56021927-AAA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Casodex
Product Name: Bicalutamide
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BICALUTAMIDE
CAS Number: 90357-06-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: - To characterize the safety profile of JNJ-56021927 plus GnRH agonist in subjects with high-risk, localized or locally advanced prostate cancer receiving primary RT
- To determine if JNJ-56021927 plus GnRH agonist in subjects with high-risk, localized or locally advanced prostate cancer receiving primary RT results in an improvement of:
- Time to local-regional recurrence
- Time to castration-resistant prostate cancer (CRPC)
- Time to distant metastasis
- Overall survival (OS)

Main Objective: To determine if JNJ-56021927 plus gonadotropin releasing hormone (GnRH) agonist in subjects with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of metastasis-free survival (MFS) evaluated by blinded independent central review (BICR)

Primary end point(s): Metastasis-free survival

Timepoint(s) of evaluation of this end point: 72 Months

Secondary Outcome(s)

Secondary end point(s): - Time to Local-regional Recurrence
- Time to Castration-resistant Prostate Cancer (CRPC)
- Time to Distant Metastasis
- Overall Survival (OS)

Timepoint(s) of evaluation of this end point: - 72 Months
- 72 Months
- 72 Months
- 72 Months

Secondary ID(s)

56021927PCR3003

Source(s) of Monetary Support

Janssen-Cilag International NV