Clinical trial NCT05753566: Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
Official title: Efficacy and Safety of Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer: A Prospective, Multi-centre Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Biochemical Recurrence
Keywords: Prostate cancer
Biochemical recurrence
Rezvilutamide
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2023-03-03
Enrollment: 96
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: 2-year biochemical progression-free survival
timeFrame: 24 months
measure: 3-year biochemical progression-free survival
timeFrame: 36 months
Secondary outcomes:
measure: biochemical progression-free survival
timeFrame: 36 months
measure: progression-free survival (PFS)
timeFrame: 36 months
measure: metastasis-free survival (MFS)
timeFrame: 36 months
measure: Quality of life as determined by FACT-P scores
timeFrame: At baseline, 3 months, 6 months, every 3 months up to 3 years
measure: Quality of life as determined by EPIC-26 questionnaire
timeFrame: At baseline, 3 months, 6 months, every 3 months up to 3 years
measure: Number of Adverse Events
timeFrame: 36 months
measure: Duration of testosterone recovery
timeFrame: 36 months
measure: Time to testosterone recovery to >50 ng/dl
timeFrame: 36 months
measure: Time to testosterone recovery to >300 ng/dl
timeFrame: 36 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanjing
country: China
facility: JiangSu Cancer Hospital
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Chief physician of Department of Urology
role: PRINCIPAL_INVESTIGATOR
References: