Not yet recruiting NCT07208292
Real-world Study on Preoperative Application of Rezvilutamide
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Preoperative Evaluation. Basic parameters: from 18 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
- Center list to be confirmed — check the primary protocol.
- 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 →
Overview
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, etc.
Primary outcome measures
- Pathological Complete Response（PCR） [Time frame: Postoperative Immediate Pathological Diagnosis]
- Minimal Residual Disease(MRD) [Time frame: Postoperative Immediate Pathological Diagnosis]
- Biochemical Recurrence(BCR) [Time frame: through study completion, an average of 2 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07208292 · GLYY1s2025-040 · mierxiati@fudan.edu.cn