Preoperative EvaluationRWS-GU001NCT07208292
Real-world Study on Preoperative Application of Rezvilutamide
An observational study of Preoperative Evaluation, run by Shanghai Pudong New Area Gongli Hospital.
Trial summary
Real-world study on Preoperative Application of Rezvilutamide Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Preoperative Evaluation
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2025to 15 Jul 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: A description of the population from data from Postoperative Patients with Prostate Cancer
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Real-world study on Preoperative Application of Rezvilutamide
Read the detailed description
Observation on Postoperative and Long-term Indicators of Rezvilutamide in Perioperative Medication, Including Postoperative Pathological Complete Response Rate, Postoperative Biochemical Recurrence, etc.
- Conditions
- Preoperative Evaluation
- Keywords
- prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start15 Oct 2025 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative EvaluationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai Pudong New Area Gongli Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mierxiati Abudurexiti, Study chair, Shanghai Pudong New Area Gongli Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208292
- Sponsor's protocol ID
- GLYY1s2025-040
- Other IDs
- mierxiati@fudan.edu.cn
- Acronym
- RWS-GU001
- Status last verified
- Sep 2025
- First submitted
- 23 Jul 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Study on Preoperative Application of Rezvilutamide
- ClinicalTrials.gov ID
- NCT07208292
- Acronym / sponsor ID
- RWS-GU001 / GLYY1s2025-040
- Conditions
- Preoperative Evaluation
- Keywords
- prostate cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Shanghai Pudong New Area Gongli HospitalUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A description of the population from data from Postoperative Patients with Prostate Cancer
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mierxiati Abudurexiti study chair
Shanghai Pudong New Area Gongli Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Preoperative Evaluation, run by Shanghai Pudong New Area Gongli Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mierxiati Abudurexiti, MD. PhD. (18939915308, mierxiati@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response（PCR） (time frame: Postoperative Immediate Pathological Diagnosis). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.