Dose increase after injection of biodegradable material A safety study of high-risk prostate cancer patients who underwent low-fractionation curative radiation therapy and hormone therapy
Histopathologically confirmed prostate adenocarcinoma within 6 months of study enrollment
Patients with prostate cancer at high risk or above (c T3a-T4 or grade group 4-5 or PSA > 20 n g/mL) )
Patients who have undergone or are scheduled to undergo hormone therapy for high-risk prostate cancer
Adults over 20 years of age
prostate removal surgery, Patients with a history of lower pelvic surgery including rectal cancer surgery
primary cancer Patients with posterior extracapsular extension
Medically biodegradable substances such as bleeding predisposition Patients for whom infusion is not appropriate
Patients with a history of previous pelvic radiation therapy
Single group
Dose increase after injection of biodegradable material A safety study of high-risk prostate cancer patients
Radiationthis researcher performed biodegradable material injection during radical radiotherapy in combination with hormone therapy in high - risk prostate cancer patients. after subdivision radical received radiation therapy We plan to conduct a phase II clinical study to evaluate the safety of prostate cancer patients.
NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) V 5.0 Frequency of rectal bleeding of grade 1 or higher within 3 years
Adverse Event within three years after the radiation therapy
Radiation therapy-related side effects other than rectal bleeding
Sigmoi doscopy is performed once a year for up to 2 years after the end of radiation therapy,
Side effects related to biodegradable material injection
biochemical recurrence-free survival
Biochemical recurrence is defined as PSA nadir + 2.0ng/ml according to the Phoenix definition, or when hormone therapy is discontinued, when hormone therapy is newly started, or when hormone therapy is in progress, when the treatment is changed.
progression-free survival
check on each participant by CT scan, MRI, Bone scan for any progressive disease
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