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

• Conditions: ow-volume Metastatic Hormone-sensitive Prostate Cancer (mHSPC); MedDRA version: 18.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-003007-38-ES
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-05
• Last Update Posted: 22 December 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 1500

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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);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<br>- 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:<br>- Time to local-regional recurrence<br>- Time to castration-resistant prostate cancer (CRPC)<br>- Time to distant metastasis<br>- Overall survival (OS);Primary end point(s): Metastasis-free survival;Timepoint(s) of evaluation of this end point: 72 Months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Time to Local-regional Recurrence<br>- Time to Castration-resistant Prostate Cancer (CRPC)<br>- Time to Distant Metastasis<br>- Overall Survival (OS);Timepoint(s) of evaluation of this end point: - 72 Months<br>- 72 Months<br>- 72 Months<br>- 72 Months