Efficacy and safety of nanosomal docetaxel lipid suspension in Indian patients with metastatic castration-resistant prostate cancer (mCRPC): A multicenter, open-label, single-arm phase 4 study.
Authors: Prabrajya NARAYAN Mohapatra, Bharat Vaswani, Padmaj Sudhakar Kulkarni, Rakesh Reddy, Nikhil Ghadyalpatil, Chandan Krushna Das, Ranga Raman Ganta, Radhika Parimkayala, Sourav Kumar Mishra, Francis James, Bhushan Tapiram Nemade, Rajeev Sood, Ateeq Ahmad, Saifuddin Sheikh, Shoukath M Ali, Mahesh Paithankar, Anil Rajani, Deepak Bunger, Alok Chaturvedi, Imran Ahmad
Journal: Journal of Clinical Oncology (2025)

168 Background: Docetaxel combined with prednisone is the first line chemotherapy to improve overall survival in metastatic castration resistant prostate cancer (mCRPC). Nanosomal docetaxel lipid suspension (NDLS) is a novel formulation that eliminates the need for polysorbate 80 and ethanol, reducing infusion-related reactions and the requirement for steroid premedication. This phase 4 trial aims to assess the efficacy and safety of NDLS in patients with mCRPC. Methods: In this multicenter, open-label, single-arm trial, patients with confirmed mCRPC and at least one measurable lesion were enrolled. Exclusions included those with brain lesions or a history of hypersensitivity to taxanes. NDLS was administered at 75 mg/m 2 every three weeks for 10 cycles without steroid premedication. The primary endpoint was the overall response rate (ORR) upon completion of 10 cycles. Results: Between July 2018 and July 2023, 86 patients (safety set) received the study drug. The modified intention-to-treat (mITT) set (included 77 patients who received at least one dose and had at least one efficacy evaluation). The mean age of the mITT set was 67 (±6.2) years, with a median prostate specific antigen (PSA) value of 31.3 ng/mL. At the end of 10 cycles, the overall response rate (ORR) was 16.9% (95% CI: 9.31, 27.14), and the disease control rate (DCR) was 44.2% (95% CI: 32.84, 55.93). A ≥50% reduction in serum PSA was observed in 36 (46.8%) patients. The visual analog score (VAS) decreased significantly from baseline with a mean difference of 12.8 mm (P&lt;0.0001). Median progression free survival (PFS) was 12 months (95% CI: 8.12, 18.12), and the overall survival rates at 1 and 2 years were 31.2% and 19.5% respectively. Adverse events were reported in 64 (84.4%) patients, with only one patient experiencing a grade ≥3 adverse event. Common grade 1/2 adverse events (≥10% of patients) included diarrhea, vomiting, asthenia, alopecia, headache, anemia, fever, infections, and pain. Conclusions: NDLS showed efficacy and safety in patients with metastatic castration-resistant prostate cancer. Clinical trial information: CTRI/2018/02/012212 . Efficacy outcomes at cycle 10 completion. Parameter mITT set (N=77) PR, n (%) 13 (16.9) SD, n (%) 21 (27.3) ORR, (95% CI) 16.9% (9.31, 27.14) DCR, (95% CI) 44.2% (32.84, 55.93) BOR, (95% CI) 26.0% (16.64, 37.23) ≥50% reduction in serum PSA, n (%) 36 (46.8) Change from baseline for VAS (mm), mean (±SD) 12.8 (±22.11) (p&lt;0.0001) Median PFS (months), (95% CI) 12 (8.12, 18.12) Median OS (months) Not reached PR: partial response; SD: stable disease; BOR: Best overall response.