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An Efficacy and Safety Study of JNJ56021927 (ARN509) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
EU CTIS ID: 2023-505246-26-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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 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
You likely can't join if
- - 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
- - 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
See the full eligibility criteria
Who can join
- - 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 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
- - 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
What rules you out
- - 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
- - 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
- - Prior treatment with GnRH analog 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 expected to require long-term use of corticosteroids during the study
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- Israel
- Mexico
- Canada
- Argentina
- Russian Federation
- United Kingdom
- Turkey
- China
- United States
- Korea, Republic of
- Ukraine
- Malaysia
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; Israel; Mexico; Canada; Argentina; Russian Federation and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.