Prostate cancer
Conditions
Interventions
focal dose escalation
peripheral dose escalation
Sponsors
Kitasato univeristy
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Patients pathologically diagnosed with prostate cancer (adenocarcinoma) (2) Un-favorite intermediate-, high-, or very-high-risk patients according to the NCCN classification (3) Patients with PSA level (ng/ml) less than 100 (4) Patients aged between 20 and 90 on the date of informed consent (5) Performance status (PS) is an ECOG criterion for patients with a score of 0 to 1. (6) Patients who can detect lesions on T2-weighted or diffusion-weighted MRI (7) Written consent has been obtained
Exclusion criteria
Exclusion criteria: (1) Patients with active multiple cancers (excluding metachronous multiple cancers with an expected prognosis of 5 years or longer and synchronous multiple cancers with an expected prognosis of 5 years or longer with treatment) (2) Patients with uncontrolled diabetes (HbAlc 8.0% or more as a guideline) (3) Patients judged by the attending physician to have serious complications such as connective tissue disease, heart disease, respiratory disease, liver disease, etc. (4) Patients who are complicated by psychosis or psychiatric symptoms and are judged to be difficult to participate in the study (5) Patients who have previously received radiotherapy to the pelvis (6) Patients who have undergone surgical therapy for the prostate (transurethral prostatectomy, subcapsular prostatectomy, orchiectomy, etc.) or HIFU (high-intensity focused ultrasound) (7) Patients who received chemotherapy other than androgen deprivation therapy for prostate cancer (8) Patients with inflammatory bowel disease such as Crohn's disease or ulcerative colitis (9) Patients who are judged to be unable to comply with dose restrictions due to the proximity of risk organs such as the urethra and large intestine to the PTV estimated by diagnostic imaging. (10) Patients who are judged inappropriate for clinical trial participation by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| >=Grade 2 toxicity rates at 1 year after treatment | — |
Countries
Japan
Contacts
Public ContactKoji Inaba
National cancer center hospital Department of radiation oncology
Outcome results
None listed