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).
Age ≥ 40 years, male.
Patients with histologically-confirmed diagnosis of prostate adenocarcinoma.
pathologically node-negative (pN0) or pathologically node cannot be assessed (pNx);
Patients with PSA < 0.1ng/ml within 8 weeks after radical prostatectomy (RP) and maintained for at least 6 months;
Prior hormonal therapy (antiandrogens or gonadotropin releasing hormone) or prior radiotherapy to pelvic .
Postoperative biochemical recurrence with PSA > 2 ng/ml.
Postoperative pathology containing neuro-endocrine differentiation or small cell features.
Prior malignancy other than prostate cancer in the past three years.
Parallel
Rezvilutamide
DrugSpecifications of 80 mg; orally, once a day
Androgen deprivation therapy (ADT)
DrugAndrogen 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
RadiationSRT 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)
2-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)
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)
biochemical progression-free survival
Time from entry to biochemical progression or death due to any cause.
progression-free survival (PFS)
Time from entry to biochemical progression or radiologically confirmed progressive disease or death due to any cause.
metastasis-free survival (MFS)
Time from entry to radiologically confirmed metastasis disease or death due to any cause.
Quality of life as determined by FACT-P scores
Quality of life as determined by Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborator
