Status:
NOT_YET_RECRUITING
Real-world Study on Preoperative Application of Rezvilutamide
Lead Sponsor:
Shanghai Pudong New Area Gongli Hospital
Conditions:
Preoperative Evaluation
Eligibility:
MALE
18+ years
Brief Summary
Real-world study on Preoperative Application of Rezvilutamide
Detailed Description
Observation on Postoperative and Long-term Indicators of Rezvilutamide in Perioperative Medication, Including Postoperative Pathological Complete Response Rate, Postoperative Biochemical Recurrence, e...
Eligibility Criteria
Inclusion
- Pathological confirmation: Confirmed as prostate adenocarcinoma by ultrasound/MRI-guided prostate biopsy, with ISUP grade ≥ 2 (Gleason score ≥ 7);
- Clinical staging (based on AJCC 8th edition):High-risk localized: cT3a or PSA \> 20 ng/ml or Gleason score ≥ 8;Locally advanced: cT3b-4 or positive pelvic lymph nodes (cN1);
- Surgical feasibility: Multidisciplinary team (MDT) assessment considers that R0/R1 resection can be achieved;
- Laboratory requirements:Hemoglobin ≥ 90 g/L, platelets ≥ 100×10\^9/L;Liver function: ALT/AST ≤ 2.5×ULN, bilirubin ≤ 1.5×ULN;Renal function: eGFR ≥ 30 mL/min/1.73m².
Exclusion
- Disease-related: Distant metastasis (M1, including bone metastasis or visceral metastasis);Pathology indicating neuroendocrine differentiation or small cell carcinoma component \> 10%;
- Treatment-related:Previous history of receiving radiotherapy, cryotherapy, or systemic chemotherapy for prostate cancer;History of other malignant tumors within 5 years (except non-melanoma skin cancer);
- Comorbidities: Uncontrolled cardiovascular diseases (e.g., NYHA Class III heart failure, myocardial infarction within 6 months);History of severe epilepsy (requiring long-term use of anticonvulsant drugs);・Others:Known allergy to relugolix or LHRH analogs;Participation in other interventional clinical trials.
Key Trial Info
Start Date :
October 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 15 2027
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT07208292
Start Date
October 15 2025
End Date
July 15 2027
Last Update
October 6 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.