Real-world Study on Preoperative Application of Rezvilutamide

NCT07208292 | Not Yet Recruiting DMC

• 2 other identifiers: GLYY1s2025-040mierxiati@fudan.edu.cn
• Study Type: observational
• Target: 115
• Locations: 0 countries
• Sites: N/A

Brief Summary

Real-world study on Preoperative Application of Rezvilutamide

Conditions

Preoperative Evaluation

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (3)

• Pathological Complete Response（PCR）

  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.

  Postoperative Immediate Pathological Diagnosis

• Minimal Residual Disease(MRD)

  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.

  Postoperative Immediate Pathological Diagnosis

• Biochemical Recurrence(BCR)

  Biochemical recurrence in prostate cancer is one in which rising serum prostate-specific antigen (PSA) levels point to the existence of disease,PSA\>0.2ng/ml

  through study completion, an average of 2 year

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A description of the population from data from Postoperative Patients with Prostate Cancer

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Pudong New Area Gongli Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Prostate Specimens Removed by Surgery

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Mierxiati Abudurexiti

  Shanghai Pudong New Area Gongli Hospital

  STUDY CHAIR

Central Study Contacts

Mierxiati Abudurexiti, MD. PhD.

CONTACT

18939915308; mierxiati@fudan.edu.cn

Mierxiati Abudurexiti

CONTACT

+8618939915308; mierxiati@fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: October 6, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share