prostatic cancer
Conditions
Interventions
Experimental arm:Prophylactic irradiation of the regional lymphatic drainage area + Radiotherapy to the prostate and metastatic lesions group (PRT)+ADT+Darolutamide
Control arm:Radiotherapy to the prostate and metastatic lesions group (PRT)+ADT+Darolutamide
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) Aged =18 and =85 years. 2) Pathologically confirmed prostate cancer, excluding pure small cell carcinoma or sarcoma, but allowing inclusion of patients with partial neuroendocrine differentiation. 3) PSMA PET confirmed the presence of 1-3 bone metastases, with regional lymph node metastasis allowed (lymph node metastasis within the abdominal pelvic cavity below the bifurcation of the abdominal aorta). If PSMA PET was not performed at diagnosis, bone scan confirmation of 1-3 bone metastases is allowed, but a PSMA PET must be reviewed before enrollment. 4) Prior systemic treatment (endocrine therapy, chemotherapy, targeted therapy, radionuclide therapy) before enrollment is permitted. 5) No history of pelvic radiotherapy, external beam radiotherapy to the prostate, or brachytherapy, or radical prostatectomy. 6) ECOG performance status of 0-2. 7) Agreement to enroll and sign an informed consent form. 8) Ability to comply with radiotherapy positioning and treatment. 9) Ability to complete quality of life questionnaires. 10) Laboratory tests meet the following criteria.
Exclusion criteria
Exclusion criteria: 1) History of external beam radiotherapy or brachytherapy to the primary lesion, or history of radical prostatectomy. 2) Non-regional lymph node metastasis and/or visceral metastasis confirmed by PSMA PET/CT/MR within 90 days prior to randomization. 3) Progression to the hormone-resistant stage (mCRPC). 4) Subjects deemed unsuitable for participation in the clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute hematologic toxicity;Hematologic toxicity after 1 year of treatment;Time to subsequent anti-tumor treatment;Time to mCRPC;Overall Survival;Quality of life; | — |
Countries
China
Contacts
Public ContactQi xin
Peking University First Hospital
Outcome results
None listed