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

Phase 1

• Conditions: High- or very high-risk, localized or locally advanced prostate cancer; MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-20
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• 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 stage per AJCC 8th Edition,
2) Gleason score 7, PSA >=20 nanogram per mililiters (ng/mL), and >=cT2c stage per AJCC 8th Edition,
- Charlson comorbidity index (CCI) <=3
- An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1
- Adequate organ function: 1)aspartate aminotransferase (AST), alanine aminotransferase (ALT), within normal limits (WNL)
2) total bilirubin WNL
3) Serum creatinine <1.5 mg/dL (<133 µmol/L)
4) Platelets =140,000/µL, independent of transfusion and/or growth factors within 3 months prior to randomization
5) Hemoglobin = 12.0 g/dL (7.4 mmol), independent of transfusion and/or growth factors within 3 months prior to randomization
- 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 (clinical stage M1). Isolated pelvic nodal
disease below the iliac bifurcation (clinical stage N1) is not an exclusion.
Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Patients are considered eligible only if the central radiological review confirms clinical stage M0.
- 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 local (eg, radical prostatectomy, cryotherapy) treatment for prostate cancer
- History of seizure or any 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 (including cyproterone acetate) 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 subject 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 apalutamide, 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