prostate cancer
Conditions
Interventions
experimental group:Systemic treatment + radical treatment for primary lesion + stereotactic body radiation therapy (SBRT) for metastatic lesions
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically confirmed de novo prostate adenocarcinoma (can be accompanied by neuroendocrine differentiation, but accounts for less than 10% of the total tumor components); 2)Aged between 18 and 80 years; 3)Had metastatic lesions confirmed by traditional imaging examination, and the metastatic lesions number <= 5 (traditional imaging examination includes: bone scan (ECT), chest, abdominal and pelvic CT or MRI): a) Metastases are limited to bone or lymph nodes; b) Visceral metastases are not allowed; c) Patients may have any number and size of pelvic nodal metastases; 4)Adequate performance status (ECOG 0–1); 5)Systemic treatment received before enrollment was no more than 6 months (including simple castration, castration combined with traditional anti-androgen therapy, castration combined with docetaxel chemotherapy; castration combined with new-generation androgen signaling pathway inhibitors such as abiraterone, apatamide or enzalutamine); 6)No previous pelvic radiotherapy history; 7)The primary lesion of prostate cancer has not received any form of local treatment (surgery, radiotherapy, cryotherapy, radiofrequency ablation, etc.); 8)The metastatic lesions of prostate cancer have not received any form of local treatment (surgery, radiotherapy, cryotherapy, radiofrequency ablation, etc.); 9)Had normal heart, lung, liver and kidney function, could tolerate local treatment of primary and metastatic lesions (surgery or external radiotherapy), and the treatment would not cause severe adverse events to the patient. Severe adverse events include death, severe urinary incontinence, rectal injury, fatal hemorrhage, pathological fracture, severe vascular and nerve compression, paraplegia, etc. 10)Participated voluntarily and written informed consent signed; 11)Willing and expected to comply with treatment and follow up schedule. 12)Expected survival time longer than 1 year.
Exclusion criteria
Exclusion criteria: 1) Received prior local treatment for primary lesion or metastatic lesions, including radical prostatectomy, radical radiotherapy, surgery or radiotherapy to metastatic lesion; 2) Received prior systemic treatment for prostate cancer longer than 6 months; 3) Had any visceral metastases (liver, lung, brain etc.); 4) Histologically or cytologically confirmed small cell prostate cancer; 5) Unable to tolerate the treatment for primary and metastatic lesion; 6) Not willing to accept potential related adverse events caused by treatment for primary and metastatic lesion; 7) Had any other previous or current malignant disease, except for curatively treated skin basal cell carcinoma or other tumors cured for more than 5 years; 8) Had other severe disorders, such as: Unstable cardiac disease; Myocardial infarction less than 6 months prior to enrollment; Clinically significant cardiac failure requiring treatment, defined as New York Heart Association (NYHA) class III; Uncontrolled hypertension; Severe neurological or psychological disorder including dementia or epilepsy; Uncontrolled active infection; Acute gastric ulcer; Hypercalcemia; Chronic obstructive pulmonary lung disease requiring hospitalization; Any other significant disorders that in the investigator's opinion means the participant is unfit for any of the study treatments; 9) Had participated in other clinical trial before enrollment. 10) Had contraindications to radiotherapy or unsuitable for radical radiotherapy evaluated by radiologists and radiation therapists.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Imaging progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total survival time;PSA-PFS;EORTC QLQ-C30; | — |
Countries
China
Contacts
Public ContactBo Dai
Department of Urology, Fudan University Shanghai Cancer Center
Outcome results
None listed