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RECRUITINGPhase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Main Who May Qualify: 1. Age ≥ 40 years, male. 2. Patients with histologically-confirmed diagnosis of prostate adenocarcinoma. 3. pathologically node-negative (pN0) or pathologically node cannot be assessed (pNx); 4. Patients with PSA \< 0.1ng/ml within 8 weeks after radical prostatectomy (RP) and maintained for at least 6 months; 5. 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); 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; 7. Estimated life expectancy \>10 year; 8. 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%. 9. 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. 10. Signed willing to sign a consent form. Main Who Should NOT Join This Trial: 1. Prior hormonal therapy (antiandrogens or gonadotropin releasing hormone) or prior radiotherapy to pelvic . 2. Postoperative biochemical recurrence with PSA \> 2 ng/ml. 3. Postoperative pathology containing neuro-endocrine differentiation or small cell features. 4. Prior malignancy other than prostate cancer in the past three years. 5. History of any of the following: - Seizure or known condition that may pre-dispose to seizure ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Main Inclusion Criteria: 1. Age ≥ 40 years, male. 2. Patients with histologically-confirmed diagnosis of prostate adenocarcinoma. 3. pathologically node-negative (pN0) or pathologically node cannot be assessed (pNx); 4. Patients with PSA \< 0.1ng/ml within 8 weeks after radical prostatectomy (RP) and maintained for at least 6 months; 5. 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); 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; 7. Estimated life expectancy \>10 year; 8. 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%. 9. 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. 10. Signed informed consent. Main Exclusion Criteria: 1. Prior hormonal therapy (antiandrogens or gonadotropin releasing hormone) or prior radiotherapy to pelvic . 2. Postoperative biochemical recurrence with PSA \> 2 ng/ml. 3. Postoperative pathology containing neuro-endocrine differentiation or small cell features. 4. Prior malignancy other than prostate cancer in the past three years. 5. 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) 6. Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial.

Treatments Being Tested

DRUG

Rezvilutamide

Specifications of 80 mg; orally, once a day

DRUG

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

RADIATION

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)

Locations (2)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
JiangSu Cancer Hospital
Nanjing, Jiangsu, China