prostate cancer
Conditions
Interventions
PSMA PET/MRI guided radiotherapy group:PSMA PET/MRI guided radiotherapy
MRI guided radiotherapy group:MRI guided radiotherapy
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1) Age = 18 years old 2) The primary lesion was confirmed by pathological data as prostate cancer 3) Generally in good condition, with an ECOG score of = 2 points or a KPS score of = 70 points 4) High risk prostate cancer (PSA>20ng/ml, Gleason>7, = cT2c) 5) Choosing radiation therapy 6) If the patient receives PSMA PET/MRI (intervention group 2), include the PSMA PET/MRI results in the radiation therapy plan 7) Provide signed and dated informed consent form 8) Declare willingness to comply with all research procedures
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1) Under 18 years old 2) Any imaging or biopsy performed prior to randomization with extrapelvic metastasis (M1 disease) 3) Previous pelvic radiation therapy 4) Contraindications to radiotherapy (including active inflammatory bowel disease) 5) Simultaneous or previous prostate surgery or systemic treatment during randomization 6) Has undergone major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures within the past 4 weeks. 7) There are severe metabolic disorders or secondary reactions to systemic diseases or cancer, which can lead to high medical risk and/or uncertainty in survival evaluation. 8) There may be other acute or chronic diseases, mental illnesses, or abnormal laboratory test values that may increase the risk of medication administration, interfere with research results, or classify patients as ineligible to participate in this study based on the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| local control;overall survival;progression-free survival;biochemical recurrence-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;distant metastasis-free survival;Change in initial treatment intention; | — |
Countries
China
Contacts
Public ContactZuolin Xiang
Shanghai East Hospital
Outcome results
None listed