prostate cancer
Conditions
Interventions
neoadjuvant raiotherapy group:Neoadjuvant radiotherapy plus radical prostatectomy
Sponsors
Department of Urology, Shanghai Changhai Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Men aged below 75 years; 2. Men with a diagnosis of prostate adenocarcinoma confirmed by biopsy results; 3. Men diagnosed with retroperitoneal lymph node-positive prostate cancer (M1a) using contrast-enhanced CT, MRI, bone scan, and/or 68Ga-PSMA PET/CT; 4. ECOG 0-1; 5. Men with an expected survival exceeding 5 years; 6. The participant is well-informed of the current treatment options and the design of this trial; he is willing and able to give informed consent for participation in the study.
Exclusion criteria
Exclusion criteria: A patient may not enter the study if ANY of the following applies: 1. Lymph node metastasis spreading beyond pelvic and retroperitoneal nodes; 2. Bone metastasis or distant organ metastasis; 3. Prior exposure to any treatment for prostate cancer, including radiotherapy, chemotherapy, hormone therapy, focal therapy, etc.; 4. Prior transurethral enucleation or resection of the prostate; 5. Any abdominal surgery performed within 3 months prior to enrollment; 6. A transrectal prostate biopsy performed within 2 weeks prior to enrollment; 7. Sustained use of anticoagulation and antiplatelet drugs; 8. Any other previous or current malignancies; 9. Disease complicated by other severe systemic diseases which, in the judgment of the investigators, are likely to interfere with the treatment, assessment or compliance associated with this trial; 10. Participation in other trials which are ongoing or have been completed within 3 months; 11. Any contraindications for radiation therapy or surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| early and late toxicity of radiotherapy;Maximal tolerable dose of radiation therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| perioperative safety;prostate specific antigen (PSA);rate of positive surgical margins;quality of life;testosterone level;continence;erectile function; | — |
Countries
China
Contacts
Public ContactShancheng Ren
Department of Urology, Shanghai Changhai Hospital
Outcome results
None listed