drugset / Trial / NCT05717582

Maximal Cytoreductive Therapies on Post-treatment Metastases in Pts With mHSPC During Apalutamide Plus ADT Treatment

NCT05717582

Phase 2 Not yet recruiting 47 enrolled Fudan University
NaSingle-groupOpen-labelTreatment

Summary

To assess the feasibility and safety of Maximal cytoreductive therapies in patients with de novo mCSPC who achieve ≤10 oligopersistent metastases on PSMA PET CT after initial 3-month systemic treatment with apalutamide plus ADT. Maximal cytoreductive therapies consist of 1.cytoreductive radical prostatectomy with/without PLND guided by post-treatment PET 2.metastasis-directed therapy with radiation guided by post-treatment oligopersistent metastases. All patients receive continuous systemic treatment with apalutamide plus ADT.

Timeline

Start
2023-05-01
Primary completion
2025-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Apalutamide Small molecule 240 mg Oral