Prostate cancer
Conditions
Interventions
Prostate bed group:Patients receive prostate bed radiotherapy with a gradual increase in dose according to dose escalation rules
Tumor bed + pelvic lymph node drainage area group:Patients received radiotherapy in the prostate bed and pelvic lymph node drainage area, and the dose was gradually increased according to the dose esc
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. History of histologically confirmed clinically localized adenocarcinoma of the prostate with definite treatment for radical prostatectomy 2. Meet the indications for postoperative radiotherapy. Postoperative adjuvant radiotherapy: adverse pathological factors include positive pathological margins, prostate capsule invasion or seminal vesicle invasion, pathological T3 or T4, Glesson score 8~10 points, etc.; Postoperative salvage radiotherapy: Postoperative PSA continues to increase (biochemical recurrence). 3. Volunteer to participate in this clinical observation, have the ability to choose treatment independently and sign written informed consent to participate in clinical observation. 4. Male, aged 18 years or older on the day of signing the informed consent form; 5. Have good urinary control: able to fully control urination without or only occasionally using urinary incontinence pads (= 1.5×10^9 /L; Hemoglobin >= 9 g/dL (no red blood cell concentration transfusion within 2 weeks); Platelets >= 100×10^9 /L; ALT = 50ml/min; Coagulation function (PT, APTT, TT, Fbg) is normal or abnormal and not clinically significant; 7. Life expectancy of more than 12 months; 8. ECOG physical status of 0 or 1 point; 9. Willing and able to comply with study and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Patients who have received pelvic radiotherapy; 2. Patients who have not undergone pelvic lymph node dissection, and the postoperative examination results indicate pelvic lymph node metastasis or distant metastasis. After pelvic lymph node dissection, the re-examination shows pelvic lymph node metastasis or distant metastasis. 3. Patients with prostate neuroendocrine carcinoma. 4. Presence of other gastrointestinal diseases such as Crohn's disease and ulcerative colitis 5. It is estimated that the patient's compliance with this clinical study is insufficient;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the maximum tolerated dose(MTD);Dose-limiting toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| PSA progression-free survival;Local progression-free survival;Late genitourinary and gastrointestinal toxicity;Patient quality of life assessment (EPIC-26, IPSS); | — |
Countries
China
Contacts
Public ContactYali Shen
Department of Abdominal Oncology, West China Hospital of Sichuan University
Outcome results
None listed