Menu
Recruiting NCT05753566

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

Phase II Interventional Prostate Cancer Biochemical Recurrence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rezvilutamide, Androgen deprivation therapy (ADT), SRT.
Who it may be relevant to
Registry conditions: Prostate Cancer, Biochemical Recurrence. Basic parameters: from 40 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • 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)

Primary outcome measures

  • 2-year biochemical progression-free survival [Time frame: 24 months]
  • 3-year biochemical progression-free survival [Time frame: 36 months]
Secondary outcome measures (9)
  • biochemical progression-free survival [Time frame: 36 months]
  • progression-free survival (PFS) [Time frame: 36 months]
  • metastasis-free survival (MFS) [Time frame: 36 months]
  • Quality of life as determined by FACT-P scores [Time frame: At baseline, 3 months, 6 months, every 3 months up to 3 years]
  • Quality of life as determined by EPIC-26 questionnaire [Time frame: At baseline, 3 months, 6 months, every 3 months up to 3 years]
  • Number of Adverse Events [Time frame: 36 months]
  • Duration of testosterone recovery [Time frame: 36 months]
  • Time to testosterone recovery to >50 ng/dl [Time frame: 36 months]
  • Time to testosterone recovery to >300 ng/dl [Time frame: 36 months]

Eligibility criteria

Main Inclusion Criteria:

  • Age ≥ 40 years, male.
  • Patients with histologically-confirmed diagnosis of prostate adenocarcinoma.
  • pathologically node-negative (pN0) or pathologically node cannot be assessed (pNx);
  • Patients with PSA < 0.1ng/ml within 8 weeks after radical prostatectomy (RP) and maintained for at least 6 months;
  • 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);
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
  • Estimated life expectancy >10 year;
  • 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%.
  • 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.
  • Signed informed consent.

Main Exclusion Criteria:

  • Prior hormonal therapy (antiandrogens or gonadotropin releasing hormone) or prior radiotherapy to pelvic .
  • Postoperative biochemical recurrence with PSA > 2 ng/ml.
  • Postoperative pathology containing neuro-endocrine differentiation or small cell features.
  • Prior malignancy other than prostate cancer in the past three years.
  • 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)
  • Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing
  • JiangSu Cancer Hospital — Nanjing

Identifiers

NCT: NCT05753566 · IUNU-PC-119

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗