Site Editor
Sandy Srinivas, MD
Sandy Srinivas, MD
Posted: Friday, March 3, 2023
The controlled phase II EORTC-GUCG 1532 trial of patients with hormone-naive prostate cancer and noncastrate testosterone levels (≥ 230 ng/dL) showed that monotherapy with the androgen receptor inhibitor darolutamide without androgen-deprivation therapy was associated with a significant prostate-specific antigen (PSA) response. Bertrand F. Tombal, MD, PhD, of the Université Catholique de Louvain, Brussels, and colleagues reported on the efficacy and safety results of this open-label, randomized study during the 2023 American Society for Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (Abstract 160).
“Darolutamide monotherapy was associated with significant PSA response in nearly all men with hormone-naive prostate cancer,” the investigators commented. “Testosterone level changes and most common adverse events were consistent with potent androgen receptor inhibition.”
Participants in the 24-week study included 61 men with hormone-naive, histologically confirmed prostate cancer at any stage with a maximum of four metastatic lesions. Patients were randomly assigned to one of two arms: 600 mg of darolutamide two times per day or a commercially available luteinizing hormone–releasing hormone analog.
The baseline median PSA level was 8.9 ng/mL (2.2–333.8 ng/mL). A total of 21 evaluable patients in the darolutamide arm had available PSA values at baseline and at week 24. Patients in the darolutamide arm had a 100% PSA response rate (> 80% PSA decline at week 24) and a median decrease at week 24 of –99.6% (–94.3 to –100) compared with baseline levels. At 24 weeks, serum testosterone levels had increased from baseline by a median of 43.4% (5.7%–144.0%).
Drug-related adverse events were mostly grade 1 or 2 and were reported in 45.2% of patients in the darolutamide arm. Treatment-emergent adverse events most often presented as gynecomastia, fatigue, and hot flush. Serious adverse events were experienced by 3.1% of patients and were not thought to be drug related.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
2023 ASCO GU Cancers Symposium
JNCCN Spotlights
