To evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy(ADT) and standard salvage radiation therapy(SRT) or SRT combination with ADT in prostate cancer patients with biochemical recurrence of prostate-specific antigen(PSA) persistence after radical prostatectomy(RP).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Specifications of 80 mg; orally, once a day
Androgen deprivation therapy (ADT), the ADT used by each subject will be determined by the investigator,and the dose and frequency of administration will be consistent with the prescription information
SRT according to standard of care (66.6-72 grays will be delivered to the bed of prostate ,\~50.4 grays to the pelvis if needed)
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, China
RECRUITINGThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
RECRUITING3-year biochemical progression-free survival
biochemical progression is defined as a confirmed prostate specific antigen (PSA) greater than (\>) 0.2 nanogram per milliliter (ng/ml) ( the time interval should be over 2 weeks)
Time frame: 48 months
progression-free survival (PFS)
Time from entry to biochemical progression or radiologically confirmed progressive disease or death due to any cause
Time frame: 48 months
metastasis-free survival (MFS)
Time from entry to radiologically confirmed metastasis disease or death due to any cause.
Time frame: 48 months
percentage of undetectable PSA
percentage of undetectable PSA is defined as the proportion of subjects with a PSA level ≤ 0.1 ng/mL after enrollment
Time frame: 48 months
ctDNA-positive rate
ctDNA-positive rate was defined as the number of ctDNA subjects detected in the total enrolled population
Time frame: 48 months
ctDNA clearance rate
Defined as the number of patients who were ctDNA-positive at enrollment to ctDNA-negative after treatment as a proportion of ctDNA-positive patients enrolled
Time frame: 48 months
Adverse Events
According to NCI-CTCAE v5.0
Time frame: 48 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.