Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
- Conditions
- Prostate CancerBiochemical Recurrence
- Interventions
- Registration Number
- NCT05753566
- Lead Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 96
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Age ≥ 40 years, male.
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Patients with histologically-confirmed diagnosis of prostate adenocarcinoma.
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pathologically node-negative (pN0) or pathologically node cannot be assessed (pNx);
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Patients with PSA < 0.1ng/ml within 8 weeks after radical prostatectomy (RP) and maintained for at least 6 months;
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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);
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Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
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Estimated life expectancy >10 year;
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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%.
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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.
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Signed informed consent.
Main
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Prior hormonal therapy (antiandrogens or gonadotropin releasing hormone) or prior radiotherapy to pelvic .
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Postoperative biochemical recurrence with PSA > 2 ng/ml.
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Postoperative pathology containing neuro-endocrine differentiation or small cell features.
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Prior malignancy other than prostate cancer in the past three years.
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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)
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Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rezvilutamide +ADT+ SRT SRT Rezvilutamide along with ADT for 6 cycles (28 days for each cycle) in combination with salvage radiation therapy (SRT) according to standard of care Rezvilutamide +ADT Androgen deprivation therapy (ADT) Rezvilutamide along with ADT for 12 cycles (28 days for each cycle) Rezvilutamide +ADT+ SRT Androgen deprivation therapy (ADT) Rezvilutamide along with ADT for 6 cycles (28 days for each cycle) in combination with salvage radiation therapy (SRT) according to standard of care Rezvilutamide +ADT+ SRT Rezvilutamide Rezvilutamide along with ADT for 6 cycles (28 days for each cycle) in combination with salvage radiation therapy (SRT) according to standard of care Rezvilutamide +ADT Rezvilutamide Rezvilutamide along with ADT for 12 cycles (28 days for each cycle)
- Primary Outcome Measures
Name Time Method 3-year biochemical progression-free survival 36 months 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)
2-year biochemical progression-free survival 24 months For arm 1, biochemical progression is defined as a confirmed prostate specific antigen (PSA) greater than (\>) 0.2 nanogram per milliliter (ng/ml)
- Secondary Outcome Measures
Name Time Method progression-free survival (PFS) 36 months Time from entry to biochemical progression or radiologically confirmed progressive disease or death due to any cause.
Time to testosterone recovery to >50 ng/dl 36 months Time to testosterone recovery to \>50 ng/dl
Time to testosterone recovery to >300 ng/dl 36 months Time to testosterone recovery to \>300 ng/dl
biochemical progression-free survival 36 months Time from entry to biochemical progression or death due to any cause.
metastasis-free survival (MFS) 36 months Time from entry to radiologically confirmed metastasis disease or death due to any cause.
Quality of life as determined by EPIC-26 questionnaire At baseline, 3 months, 6 months, every 3 months up to 3 years Quality of life as determined by Expanded Prostate Cancer Index Composite-26 (EPIC-26) questionnaire
Number of Adverse Events 36 months Number of Adverse Events
Duration of testosterone recovery 36 months Duration of testosterone recovery
Quality of life as determined by FACT-P scores At baseline, 3 months, 6 months, every 3 months up to 3 years Quality of life as determined by Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores
Trial Locations
- Locations (2)
JiangSu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China