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NCT07208292Not yet recruiting

Real-world Study on Preoperative Application of Rezvilutamide

Source: ClinicalTrials.gov · Last updated 6 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Real-world study on Preoperative Application of Rezvilutamide

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
115 (estimated)
First submitted
23 Jul 2025
Start date
15 Oct 2025
Primary completion date
15 Jul 2026
Lead sponsor
Shanghai Pudong New Area Gongli Hospital
NCT number
NCT07208292

What you commit to

  • Study type: Observational
  • Planned participants: 115
  • From 15 Oct 2025 to the primary completion date, 15 Jul 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.