Clinical trial · Observational
Real-world Study on Preoperative Application of Rezvilutamide
NCT07208292CI-TRIAL-00096312RWS-GU001not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Real-world study on Preoperative Application of Rezvilutamide
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Preoperative Evaluation | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Pathological Complete Response（PCR）
- timeFrame
- Postoperative Immediate Pathological Diagnosis
- description
- A pathological complete response (pCR) signifies the complete absence of detectable invasive cancer cells in tissue surgically removed from a patient. This evaluation is made by a pathologist after a patient has undergone neoadjuvant therapy-a course of treatment before their primary surgery.
- measure
- Minimal Residual Disease(MRD)
- timeFrame
- Postoperative Immediate Pathological Diagnosis
- description
- Minimal residual disease is that not detected by conventional imaging studies and clinically the patient remains disease free. However, with time these dormant cells will awaken and disease progression occurs, resulting in clinically and radiological detectable metastatic disease.
- measure
- Biochemical Recurrence(BCR)
- timeFrame
- through study completion, an average of 2 year
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.