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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen - Cilag International

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

27 Jan 2016 → ongoing

Decision date (initial)

2023-10-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Janssen-Cilag International NV

External identifiers

EU CT number

2023-505246-26-00

EudraCT number

2015-003007-38

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Safety

To determine if apalutamide plus GnRH agonist in subjects with high-risk localized or locally advanced prostate cancer receiving primary RT results in an improvement of MFS based on conventional imaging assessed by BICR.

Conditions and MedDRA coding

High- or very-high risk, localized or locally advanced prostate cancer

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparecy. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. - Age >= 18 years
2. - Indicated and planned to receive primary radiation therapy for prostate cancer
3. - 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
4. - Charlson comorbidity index (CCI) <=3
5. - An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Grade of 0 or 1
6. -Adequate organ function determined by the following central laboratory values: 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
7. - Participants who are sexually active (even men with vasectomies) and willing to use a condom and agree not to donate sperm during the trial
8. - Signed, written, informed consent
9. - Be able to swallow whole study drug tablets

Exclusion criteria 17

1. - 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
2. - Prior treatment with GnRH analog or antiandrogen or both for >3 months prior to randomization
3. - Bilateral orchiectomy
4. - History of pelvic radiation
5. - Prior systemic (eg, chemotherapy) or local (eg, radical prostatectomy, cryotherapy) treatment for prostate cancer
6. - 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)
7. - Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents (including cyproterone acetate) for prostate cancer
8. - Prior treatment with radiopharmaceutical agents (eg, strontium 89) or immunotherapy (eg, sipuleucel-T) for prostate cancer
9. - Prior treatment with systemic glucocorticoids ≤4 weeks prior to randomization or subject expected to require long-term use of corticosteroids during the study
10. - Use of 5-alpha reductase inhibitors (eg, dutasteride, finasteride) <=4 weeks prior to randomization
11. - Use of any investigational agent <=4 weeks prior to randomization
12. - Current chronic use of opioid analgesics for >=3 weeks for oral or >7 days for non-oral formulations
13. - Major surgery <=4 weeks prior to randomization
14. - Current or prior treatment with antiepileptic medications for the treatment of seizures
15. - Gastrointestinal conditions affecting absorption
16. - Known or suspected contraindications or hypersensitivity to apalutamide, 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. MFS is defined as the time from randomization to the date of the first occurrence of radiographic bone or soft tissue distant metastasis based on conventional imaging assesed by BICR, histopathologic diagnosis of distant metastasis, or death from any cause, whichever occurs first.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 2

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen - Cilag International

Sponsor organisation

Janssen - Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Third parties 7

Locations

9 EU/EEA countries · 87 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 113 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications