Protocol Title: Open-label study of Androgen Receptor Inhibition with dArolutamide plus Androgen Deprivation Therapy (ADT) Versus ADT in men with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Using an External Control Arm (ARASEC)

Sponsor: Amgen Inc

Protocol Number: 21516

Key Criteria

o   Patient has histologically/cytologically confirmed adenocarcinoma of the prostate.
§  They may have started ADT (up to 120 days before enrolling in study). Relugolix is not an acceptable ADT
o   Patient has metastatic disease (classified by high volume or low volume disease).
§  High volume disease includes visceral metastases (extranodal) and/or bone metastases (> 4 lesions with at least one outside of vertebral column and pelvis)
§  Radiographically documented metastatic disease (CT/MRI, bone scan)
o   Patient may have received prior adjuvant/neoadjuvant hormonal therapy as long as it was discontinued > 12 months ago (no more than 24 months in total duration).
§  No evidence of disease at least 12 months after completing hormonal therapy.
o   Patient may receive Bicalutamide, nilutamide or flutamide as single agent therapy < 28 days before medical castration
Excluded if
§  Patient’s PSA level rises and meets criteria for PSA progression from lowest point between starting ADT and enrolling in this study
§  Patient has history of malignancy in past 5 years (except BCC or SCC of skin)
§  Patient has active cardiac disease within 6 months of starting study treatment (MI, unstable angina, CHF, cardiac event resulting in hospitalization)
§  Patient has small cell or neuroendocrine carcinoma of prostate
§  Patient has brain/leptomeningeal metastases
§  Patient has uncontrolled HTN despite medical management (Resting systolic BP >160 mmHg or diastolic BP > 100 mmHg)
§  Patient has history of receiving hormone therapy in metastatic setting
§  Patient has received prior chemotherapy in adjuvant/neoadjuvant setting
§  patient has been treated with second-generation androgen receptor inhibitors (enzalutamide, apalutamide, darolutamide, or other investigational AR inhibitors, Cytochrome P17 enzyme inhibitor like abiraterone acetate or other investigational CYP 17) as antineoplastic treatment for prostate cancer

Talking Points

  • Study objective: This study will compare the efficacy and assess progression-free survival using darolutamide in combination with androgen deprivation therapy (ADT) versus ADT alone in patients with mHSPC. All patients will receive and remain on stable regimen of ADT provided by trial site.
    • Study drug: Darolutamide is an oral, non-steroidal androgen receptor inhibitor and has a favorable efficacy, safety  and drug-to-drug interaction profile.
Scroll to Top