This multi-center randomized controlled phase II trial was carried out in several hospitals in China to evaluate the efficacy and safety of radiotherapy or radical prostatectomy combined with intense androgen deprivation therapy for newly diagnosed metastatic prostate cancer.
Histologically or cytologically confirmed prostate adenocarcinoma, with distant metastasis diagnosed by novel imaging modalities (PSMA PET/CT or PSMA PET/MR), involving ≤10 metastatic sites (amenable to local therapy) and without visceral metastasis.
The primary lesion is deemed resectable, or can achieve a resectable state following IADT.
Non-castration range (≥50 ng/dl), or the duration of testosterone levels in the castration range is no more than 3 months.
Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.
Patients with prostatic histopathology exhibiting neuroendocrine, small cell, or sarcomatoid features.
The researchers assessed the primary lesion as unresectable.
Patients who had previously received androgen deprivation therapy (including medical or surgical castration) for more than 3 months, or had undergone focal therapy for prostate cancer, or had received radiotherapy or chemotherapy for prostate cancer.
Patients with severe or uncontrolled underlying diseases who could not tolerate surgery or radiotherapy.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead sponsor
The First Affiliated Hospital of Soochow University
Collaborator
Peking University First Hospital
Collaborator