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Maximal Cytoreductive Therapies on Post-treatment Metastases in Pts With mHSPC During Apalutamide Plus ADT Treatment
Sponsor: Fudan University
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.
Official title: A Prospective Study of Maximal-Cytoreductive Therapies for Patients With de Novo Metastatic Hormone-sensitive Prostate Cancer Who Achieve Oligopersistent Metastases During Systemic Treatment With Apalutamide Plus ADT (CHAMPION Study)
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
47
Start Date
2023-05-01
Completion Date
2026-12-31
Last Updated
2023-02-08
Healthy Volunteers
No
Interventions
apalutamide
Patients receive apalutamide 240mg,qd,po.
androgen deprivation therapy
Patients receive systemic ADT.
cytoreductive radical prostatectomy with/without pelvic lymph node dissection
Patients receive cytoreductive radical prostatectomy with/without pelvic lymph node dissection.
metastasis-directed therapy with radiation
Patients receive metastasis-directed therapy with radiation guided by post-treatment oligopersistent metastases.
Locations (2)
Fudan University Shanghai Cancer Center Pudong Hospital
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center Xuhui Hospital
Shanghai, Shanghai Municipality, China