International Phase 3 Trial of Docetaxel Added to Apalutamide and Hormone Therapy in Men with Metastatic Hormone-Sensitive Prostate Cancer Without Deep PSA Response

What this Trial Is About

Researchers are evaluating treatment intensification with docetaxel plus apalutamide and androgen deprivation therapy ADT in men with metastatic hormone-sensitive prostate cancer mHSPC who have not achieved a deep PSA response after initial treatment with apalutamide and ADT. This phase III, randomized, open-label, multi-center study aims to assess whether adding docetaxel improves event-free survival compared to continuing standard treatment with apalutamide and ADT alone. Approximately 320 male patients will be randomly assigned to one of two groups. The experimental group will receive docetaxel 75 mgm2 every three weeks for six cycles along with daily oral apalutamide 240 mg and ADT. The control group will continue with standard treatment of apalutamide and ADT alone. Randomization will consider factors like timing of metastasis, presence of visceral metastasis, and PSA levels at study entry. Safety will be regularly monitored by an independent data monitoring committee. Participants will be closely followed over 48 months to evaluate event-free survival, time to castration resistance, radiographic and PSA progression-free survival, overall survival, and quality of life measures. Other assessments include safety evaluations, skeletal event monitoring, and time to opioid use. Participants must meet specific health and laboratory criteria before enrollment and will be monitored throughout for treatment response and adverse events.

Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial.