Real-world Study on Preoperative Applic… | Clinical Trial

Key information

Conditions

Preoperative Evaluation Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

About this study

Observation on Postoperative and Long-term Indicators of Rezvilutamide in Perioperative Medication, Including Postoperative Pathological Complete Response Rate, Postoperative Biochemical Recurrence, etc.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Pathological Complete Response（PCR）

Time frame: Postoperative Immediate Pathological Diagnosis

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.
Minimal Residual Disease(MRD)

Time frame: Postoperative Immediate Pathological Diagnosis

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.
Biochemical Recurrence(BCR)

Time frame: through study completion, an average of 2 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mierxiati Abudurexiti

CONTACT

[email protected]

+8618939915308

Mierxiati Abudurexiti, MD. PhD.

CONTACT

[email protected]

18939915308

Sponsors and collaborators

Lead sponsor

Shanghai Pudong New Area Gongli Hospital

Other

Registry information

Acronym: RWS-GU001

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Oct 6, 2025
Registry last updated: Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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