Localized high-risk or very-high-risk prostate cancer patients, cT3-4N0M0
Conditions
Interventions
Pelvic Radiotherapy:Pelvic radiotherapy
Pelvic Lymph Node Dissection:Extended pelvic lymph node dissection
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, provision of signed and dated informed consent form; 2.Stated willingness to comply with all study procedures and availability for the duration of the study; 3.Histologically confirmed prostate cancer patients who are scheduled to undergo radical prostatectomy; 4.Clinical stage is cT3-4N0M0 (evaluated by pelvic MRI/CT + bone scan, or PSMA-PET/CT); 5. NCCN risk stratification is localized high-risk or very-high-risk (meeting one of the following three criteria: PSA > 20ng/ml, GS score of 8-10, clinical T stage of cT3-4); 6.ECOG score of 0-2;
Exclusion criteria
Exclusion criteria: 1.Preoperative ADT; 2.Previous cancer except skin cancer rather than malignant melanoma or any cancer curatively treated > 5 years prior to study entry; 3.Treatment with chemotherapy within 6 months; 4.History of pelvic radiotherapy; 5.Clinically uncontrolled diseases, such as septic shock, unstable angina, New York Heart Association (NYHA) class III or IV heart disease, clinically unstable arrhythmia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity and quality of life;bPFS, RPFS, PCSS and OS; | — |
Countries
China
Contacts
Public ContactLi Hongzhen
Peking University First Hospital
Outcome results
None listed