Real-world Study on Preoperative Application of Rezvilutamide
ConditionPreoperative Evaluation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorShanghai Pudong New Area Gongli Hospital
About this trial
Real-world study on Preoperative Application of Rezvilutamide
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
A description of the population from data from Postoperative Patients with Prostate Cancer
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Postoperative Immediate Pathological Diagnosis2
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.
Time frame
Postoperative Immediate Pathological Diagnosis3
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
Time frame
through study completion, an average of 2 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: