To evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy(ADT) and standard salvage radiation therapy(SRT) or rezvilutamide in combination with ADT in prostate cancer patients with biochemical recurrence of prostate-specific antigen(PSA) persistence after radical prostatectomy(RP).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
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)
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
RECRUITINGJiangSu Cancer Hospital
Nanjing, Jiangsu, China
NOT_YET_RECRUITING2-year biochemical progression-free survival
For arm 1, biochemical progression is defined as a confirmed prostate specific antigen (PSA) greater than (\>) 0.2 nanogram per milliliter (ng/ml)
Time frame: 24 months
3-year biochemical progression-free survival
For arm 2, biochemical progression is defined as a confirmed PSA greater than (\>) 0.2 ng/ml( the time interval should be over 2 weeks)
Time frame: 36 months
biochemical progression-free survival
Time from entry to biochemical progression or death due to any cause.
Time frame: 36 months
progression-free survival (PFS)
Time from entry to biochemical progression or radiologically confirmed progressive disease or death due to any cause.
Time frame: 36 months
metastasis-free survival (MFS)
Time from entry to radiologically confirmed metastasis disease or death due to any cause.
Time frame: 36 months
Quality of life as determined by FACT-P scores
Quality of life as determined by Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores
Time frame: At baseline, 3 months, 6 months, every 3 months up to 3 years
Quality of life as determined by EPIC-26 questionnaire
Quality of life as determined by Expanded Prostate Cancer Index Composite-26 (EPIC-26) questionnaire
Time frame: At baseline, 3 months, 6 months, every 3 months up to 3 years
Number of Adverse Events
Number of Adverse Events
Time frame: 36 months
Duration of testosterone recovery
Duration of testosterone recovery
Time frame: 36 months
Time to testosterone recovery to >50 ng/dl
Time to testosterone recovery to \>50 ng/dl
Time frame: 36 months
Time to testosterone recovery to >300 ng/dl
Time to testosterone recovery to \>300 ng/dl
Time frame: 36 months
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