Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer

Официальное название

Efficacy and Safety of Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer: A Prospective, Multi-centre Study

Обзор

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).

Вмешательства

• Препарат Rezvilutamide
  Specifications of 80 mg; orally, once a day
• Препарат Androgen deprivation therapy (ADT)
  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
• Лучевая терапия SRT
  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)

Первичные конечные точки

• 2-year biochemical progression-free survival [Срок оценки: 24 months]
• 3-year biochemical progression-free survival [Срок оценки: 36 months]

Вторичные конечные точки (9)

• biochemical progression-free survival [Срок оценки: 36 months]
• progression-free survival (PFS) [Срок оценки: 36 months]
• metastasis-free survival (MFS) [Срок оценки: 36 months]
• Quality of life as determined by FACT-P scores [Срок оценки: At baseline, 3 months, 6 months, every 3 months up to 3 years]
• Quality of life as determined by EPIC-26 questionnaire [Срок оценки: At baseline, 3 months, 6 months, every 3 months up to 3 years]
• Number of Adverse Events [Срок оценки: 36 months]
• Duration of testosterone recovery [Срок оценки: 36 months]
• Time to testosterone recovery to >50 ng/dl [Срок оценки: 36 months]
• Time to testosterone recovery to >300 ng/dl [Срок оценки: 36 months]

Критерии участия

Main Inclusion Criteria:

• 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;
• Biochemical recurrence (two consecutive rises in PSA with absolute values > 0.2ng/ml, the time interval ≥ 2 weeks apart ) and no local recurrence or distant metastatic lesions on conventional imaging (bone scan and CT/MRI scan);
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
• Estimated life expectancy >10 year;
• Adequate laboratory parameters

• Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\^9/L
• Platelet count (PLT) ≥ 100 x 10\^9/L
• Haemoglobin (Hb) ≥ 90 g/L
• Serum creatinine (Cr) ≤ 1.5 x upper limit of normal(ULN) or creatinine clearance > 50 ml/min.
• Total bilirubin (TBIL) ≤ 1.5 x ULN.
• Glutamic oxaloacetic transaminase (AST/SGOT) or glutamic alanine transaminase (ALT/SGPT) levels ≤ 2.5 x ULN.
• International normalised ratio (INR) ≤1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT)≤1.5 x ULN .
• Left ventricular ejection fraction (LVEF) ≥ 50%.
• Patients able to comply with the protocol. Arm 1 subjects are proposed to receive salvage radiation therapy, while arm 2 subjects are not suitable for or refuse radiation therapy.
• Signed informed consent.

Main Exclusion Criteria:

• 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.
• History of any of the following:

• Seizure or known condition that may pre-dispose to seizure
• Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to entry.
• Active infection (eg, human immunodeficiency virus \[HIV\] or viral hepatitis)
• Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Нанкин
• JiangSu Cancer Hospital — Нанкин

Идентификаторы

NCT: NCT05753566 · IUNU-PC-119

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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