Using rezvilutamide for prostate cancer recurrence after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining salvage radiotherapy and androgen deprivation therapy with rezvilutamide for prostate cancer recurrence

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.