Using rezvilutamide for prostate cancer recurrence after surgery
Efficacy and Safety of Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer: A Prospective, Multi-centre Study
This study is testing if a new drug called rezvilutamide, used with hormone therapy and radiation, can help men whose prostate cancer has come back after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 40 Years and up |
| Sex | Male |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Nanjing, Jiangsu and 1 other locations) |
| Trial ID | NCT05753566 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy (ADT) and standard salvage radiation therapy (SRT) for patients experiencing biochemical recurrence of prostate cancer after radical prostatectomy. The trial aims to determine if this combination can effectively manage rising prostate-specific antigen (PSA) levels in patients who have undergone surgery. Participants will be monitored for both the effectiveness of the treatment and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates are men aged 40 and older with a confirmed diagnosis of prostate adenocarcinoma and biochemical recurrence after radical prostatectomy.
Not a fit: Patients with local recurrence or distant metastatic lesions, or those with a PSA level below the specified threshold, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for managing prostate cancer recurrence, potentially improving patient outcomes.
How similar studies have performed: While this approach is being explored, similar studies have shown promise in managing prostate cancer recurrence, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu and 1 other locations
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (Recruiting)
- JiangSu Cancer Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
Study contacts
- Principal investigator: Chief physician of Department of Urology — The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study coordinator: Hongqian Guo, phD
- Email: dr.ghq@nju.edu.cn
- Phone: +86-13605171690
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.