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

Launched by THE AFFILIATED NANJING DRUM TOWER HOSPITAL OF NANJING UNIVERSITY MEDICAL SCHOOL · Mar 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called rezvilutamide for men who have prostate cancer that has come back after surgery, specifically after a procedure called radical prostatectomy. The trial aims to find out if rezvilutamide, when used with hormone therapy and possibly with radiation treatment, is safe and effective for patients whose prostate-specific antigen (PSA) levels have risen after they were initially low following surgery. This trial is currently looking for male participants aged 40 and older who have been diagnosed with prostate cancer and meet certain health criteria.

Eligible participants should have a confirmed diagnosis of prostate cancer, with specific PSA levels indicating they have had a recurrence but no signs of cancer spread. They should also be generally healthy enough to participate, with a good performance status, meaning they can carry out daily activities without significant issues. Those who join the trial can expect to receive close monitoring and care as part of the study. It's important to note that participants will need to give their informed consent and may have to avoid certain previous treatments that could interfere with the study.

Gender

MALE

Eligibility criteria

• 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.