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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Patients receive apalutamide 240mg,qd,po.
Patients receive systemic ADT.
Patients receive cytoreductive radical prostatectomy with/without pelvic lymph node dissection.
Patients receive metastasis-directed therapy with radiation guided by post-treatment oligopersistent metastases.
Fudan University Shanghai Cancer Center Pudong Hospital
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center Xuhui Hospital
Shanghai, Shanghai Municipality, China
proportion of patients with undetectable PSA level after 6 cycles of treatment (each cycle is 28 days).
It is defined as the proportion of patients with PSA≤0.2 ng/mL without disease progression or symptomatic deterioration after 6 cycles of study treatment (each cycle is 28 days).
Time frame: At the end of the 6th cycle of treatment (each cycle is 28 days).
proportion of patients with undetectable PSA level after 3 cycles of treatment (each cycle is 28 days).
It is defined as the proportion of patients with PSA≤0.2 ng/mL after 3 cycles of study treatment (each cycle is 28 days).
Time frame: At the end of the 3rd cycle of treatment (each cycle is 28 days).
PSA50 response rate and PSA90 response rate at the end of the 3rd treatment cycle (each cycle is 28 days).
It is defined as the proportion of patients with a PSA reduction of over 50% / 90%compared with baseline.
Time frame: At the end of the 3rd cycle of treatment (each cycle is 28 days).
PSA50 response rate and PSA90 response rate at the end of the 6th treatment cycle (each cycle is 28 days).
It is defined as the proportion of patients with a PSA reduction of over 50% / 90%compared with baseline.
Time frame: At the end of the 6th cycle of treatment (each cycle is 28 days).
Conventional imaging and PSMA-PET/CT imaging features at baseline
Imaging features before hormonal therapy
Time frame: Baseline (Before trial treatment)
Proportion of patients with ≤ 10 metastases on PSMA-PET/CT imaging at the end of the third treatment cycle (each cycle is 28 days).
Proportion of patients with ≤ 10 metastases on PSMA-PET/CT imaging at the end of the third treatment cycle (each cycle is 28 days).
Time frame: At the end of the 3rd cycle of treatment (each cycle is 28 days).
Comparison of imaging features between conventional imaging and PSMA PET/CT.
Including prostate volume, tumor burden, distribution of metastatic lesions etc.
Time frame: At the end of the 3rd and 6th cycle of treatment (each cycle is 28 days).
Feasibility and safety of performing cRP±MDT treatment
Feasibility and safety of performing cRP±MDT guided by oligopersistent metastases assessed by PSMA PET/CT
Time frame: At the end of the 6th cycle of treatment (each cycle is 28 days).
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