Adjuvant Rezvilutamide Monotherapy for High-Risk Prostate Cancer After Radical Prostatectomy

Prostate cancer patients with high-risk features who undergo radical prostatectomy (RP) are at a significant risk of biochemical recurrence (BCR) and disease progression. While adjuvant androgen deprivation therapy (ADT) with or without radiotherapy is the current standard of care, long-term ADT is associated with substantial adverse effects, including metabolic syndrome, cardiovascular disease, and bone density loss, which negatively impact patients' quality of life. There is an unmet clinical need to optimize adjuvant treatment strategies to improve survival outcomes while minimizing treatme

Trial Details

NCT ID
NCT07711314
Phase
PHASE2
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Rezvilutamide Tablets
Locations (sample)
  • Nanjing, Jiangsu, China|32.06167,118.77778

Key Eligibility Criteria

  • Age and Diagnosis: Male patients aged ≥ 18 and ≤ 75 years with histologically or cytologically confirmed prostate adenocarcinoma.
  • Disease Stage and Surgery: Localized prostate cancer (assessed by conventional imaging such as CT and bone scan), having undergone radical prostate…
  • Postoperative PSA: Postoperative prostate-specific antigen (PSA) level \< 0.1 ng/mL within 8 weeks after surgery.
  • Risk Stratification: Postoperative CAPRA-S score ≥ 6, indicating a high risk of recurrence.

For full eligibility, visit ClinicalTrials.gov.

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