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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
144
Patients received ADT plus second-generation ARi (enzalutamide, apalutamide, darolutamide or rezvilutamide) for 2 years.
Those allocated radiotherapy received 70Gy/2.8Gy/25f schedule for primary tumor and 70Gy/2.6-2.8Gy/25f or 37.5Gy/7.5Gy/5f for metastatic lymph nodes and bone lesions based on the size and location. Radiation should be finished within 2 years' systemic therapy.
Those allocated surgery received robot-assisted laparoscopic radical prostaectomy plus extended pelvic lymph node dissection for local treatment. Surgery should be finished within 2 years' systemic therapy.
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, China
RECRUITINGEvent-free Survival
Following 2 years of treatment, any anti-tumor treatment was terminated for those who met complete remission until two consecutively rised PSA\>0.2ng/ml. Complete remission is interpreted as PSA level\<0.1ng/ml and absence of radiographic as well as clinical progression following the 2-year treatment, both are indispensable. The primary outcome was event-free survival (EFS), defined as the time from disease complete remission to any required anti-tumor treatment.
Time frame: 2 years
progression-free survival
Defined as from treatment initiation to PSA progression or radiographic/clinical progression. PSA progression is defined as PSA \>1 ng/ml, with two consecutive PSA measurements at least one week apart showing a 50% or greater increase from baseline). Radiographic progression is defined as development of two or more new bone metastases or progression of soft tissue lesions according to RECIST 1.1 criteria. Clinical progression is defined as worsening clinical symptoms and signs as determined by the physician.
Time frame: 4 years
Time to CRPC
Time to CRPC (castration-resistant prostate cancer (CRPC) is calculated from treatment initiation to the development of CRPC. CRPC is defined as serum testosterone at castration level (\<50 ng/dl or 1.7 nmol/l), while meeting one of the following criteria: a. Biochemical progression: Three consecutive PSA rises, each measured at least one week apart, with at least two increases exceeding 50% above baseline, and at least one PSA value \>2 ng/ml. b. Radiographic progression: Development of two or more new bone metastases, or progression of soft tissue lesions according to RECIST criteria.
Time frame: 4 years
Adverse events
valuate all adverse events (AEs) and grade them according to NCI-CTCAE v5.0.
Time frame: 4 years
Hongqian Guo, PhD
CONTACT
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