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NOT YET RECRUITING
NCT05717582
PHASE2

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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

DRUG

apalutamide

Patients receive apalutamide 240mg,qd,po.

DRUG

androgen deprivation therapy

Patients receive systemic ADT.

PROCEDURE

cytoreductive radical prostatectomy with/without pelvic lymph node dissection

Patients receive cytoreductive radical prostatectomy with/without pelvic lymph node dissection.

RADIATION

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