Who is eligible for clinical trial NCT04557059?

Participants must meet protocol criteria for Prostatic Neoplasms. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04557059 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-27

A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer (NCT04557059)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Janssen Pharmaceutica N.V., Belgium

🩺 Plain-English Summary (8th-Grade Level)

The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa alone.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (8 items).

Location: Arizona Urology Specialists — Tucson, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Histologically confirmed adenocarcinoma of the prostate
Previously treated with radical prostatectomy with or without lymph node dissection and either: a) for biochemical recurrence after radical prostatectomy (RP): any post-operative prostate-specific antigen (PSA) measurement of less than (\<) 0.1 nanogram/milliliter (ng/mL) within 12 months after RP and without any PSA greater than and equal to (\>=) 0.1 ng/mL within the 4 to 8-week period after RP or b) for persistent PSA after RP: PSA \>=0.1 ng/mL within the 4 to 8-week period after RP, confirmed by additional measurement at least 3 weeks later
Be able to swallow whole the study drug tablets or follow the instructions for admixing with apple sauce
Results of the Prostate specific membrane antigen-positron emission tomography (PSMA-PET) at screening as determined by blinded independent, central review (BICR), must be: PSMA-PET-negative for any prostate cancer lesions (that is, no loco-regional lesion and no distant lesions); or PSMA-PET-positive for at least one loco-regional (pelvic) lesion without distant extra-pelvic lesion; or PSMA PET- positive for at least one loco--regional (pelvic) lesion with extra-pelvic lesion(s).
High risk of developing metastasis defined as; a) for biochemical recurrence after RP: pathological Gleason score greater than or equal to (\>=) 8 evaluated from prostate tissue specimen at radical prostatectomy, or prostate-specific antigen doubling time (PSADT) less than or equal to (\<=) 12 months at the time of screening; b) for persistent PSA after RP: pathological Gleason score \>=8, evaluated from prostate tissue specimen at radical prostatectomy
Participants with evidence of distant metastasis on screening PSMA-PET scan must have no evidence of prostate cancer metastases on screening CT/MRI of the chest/abdomen/pelvis, Technetium 99m \[99mTc\] whole-body bone scan. Participants with a single bone lesion on 99mTc whole-body bone scan should have confirmatory imaging by CT or MRI; if the confirmatory scan confirms the bone lesion, the participant should be excluded from the study. Conventional images (99mTc-bone scan and CT/MRI) from the screening will be evaluated locally before randomization
Eastern Cooperative Oncology Group Performance Status Grade 0 or 1

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
History of pelvic radiation for malignancy
Previous treatment with androgen deprivation therapy (ADT) for prostate cancer
Previously treated for biochemical recurrence (BCR) or persistent PSA after RP (previous surgical treatment of one or more loco-regional lesions is allowed)
Prior treatment with a CYP17 inhibitor (example, oral ketoconazole, orteronel, abiraterone acetate, galeterone) or any androgen receptor (AR) antagonist including bicalutamide, flutamide, nilutamide, apalutamide, enzalutamide or darolutamide and any other medications that may lower androgen levels (estrogens, progestins, aminoglutethimide, etc.), including bilateral orchiectomy
Known or suspected contraindications or hypersensitivity to apalutamide, Luteinizing Hormone-Releasing Hormone (LHRH) agonist or any of the components of the formulations
Prior chemotherapy for prostate cancer
Any evidence of prostate cancer metastasis on computed tomography/magnetic resonance imaging (CT/MRI) of the chest/abdomen/pelvis or 99mTc whole-body bone scan, at any time prior to screening

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (141 Sites)

Arizona Urology Specialists — Tucson, Arizona
Arkansas Urology — Little Rock, Arkansas
Colorado Clinical Research — Lakewood, Colorado
Urological Research Network — Hialeah, Florida
First Urology, PSC — Jeffersonville, Indiana
Michigan Institute of Urology — Troy, Michigan
Associated Medical Professionals of Ny — Syracuse, New York
The Urology Group — Cincinnati, Ohio
Oregon Urology Institute — Springfield, Oregon
MidLantic Urology — Bala-Cynwyd, Pennsylvania
Urology Austin — Austin, Texas
Houston Metro Urology — Houston, Texas
Spokane Urology — Spokane, Washington
Bundaberg Hospital — Bundaberg,
Hervey Bay Hospital — Bundaberg,
Epworth Healthcare — East Melbourne,
St Vincent's Hospital - Melbourne — Fitzroy,
Genesis Care Hurstville — Hurstville,
Macquarie University Hospital — North Ryde,
Calvary Mater Newcastle — Waratah,
GenesisCare Wembley — Wembley,
Ordensklinikum Linz GmbH Elisabethinen — Linz,
Universitaetsklinikum Salzburg Landeskrankenhaus — Salzburg,
Medizinische Universitaet Wien — Vienna,
ZAS Augustinus — Antwerp,

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗