The optimal treatment for oligometastatic prostate cancer (OMPC) is still on its way. Accumulating evidence has proven the safety and feasibility of radical prostatectomy and local or metastasis-directed radiotherapy for oligometastatic patients. The aim of this trial is to compare the safety and feasibility outcomes of metastasis-directed neoadjuvant radiotherapy (naRT) and neoadjuvant androgen deprivation therapy (naADT) followed by robotic-assisted radical prostatectomy (RARP) to ADT combined with abiraterone for treating OMPC.
The present study will be conducted as a prospective, open-label, two arms clinical trial. Patients with ≤ 3 de novo oligometastatic PCa, diagnosed on Ga-68 prostate-specific membrane antigen (PSMA) PET/CT, will be randomized in a 1:1 ratio between arm A (hormone) and arm B (neoadjuvant hormone and RT). The patients in arm A with oligometastatic PCa will receive long-term ADT combined with abiraterone. The patients in arm B with oligometastatic PCa will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued. The primary endpoints of the study are progression-free survival (PFS) including biochemical recurrence-free survival (bPFS), and radiological progression-free survival (RPFS). The secondary endpoints include quality of life (QoL), time to CRPC, positive surgical margin (pSM), overall survival (OS), postoperative continence, and toxicities parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The patients will receive long-term ADT combined with abiraterone.
The patients will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued.
the First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
First Affiliated Hospital and Medical College of Soochow University
Suzhou, Jiangsu, China
Jiangnan University Medical Center
Wuxi, Jiangsu, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
3-year progression-free survival (PFS)
To assess progression-free survival (PFS) including biochemical recurrence-free survival (bPFS), and radiological progression-free survival (RPFS).
Time frame: Assessment progression-free survival (PFS) at 3 years
quality of life (QoL)
quality of life (QoL)
Time frame: through study completion, an average of 3 years
time to castration-resistant prostate cancer (CRPC)
To assess the time to castration-resistant prostate cancer (CRPC)
Time frame: through study completion, an average of 3 years
5-year overall survival (OS)
To assess the overall survival (OS)
Time frame: Assessment overall survival (OS) at 5 years
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The Second Affiliated Hospital of Naval Medical University
Shanghai, China
The First Affiliated Hospital of Naval Medical University
Shanghai, China