Prostate cancer
Conditions
Interventions
Standard Radiotherapy
Dose escalated Radiotherapy
Sponsors
Kitasato University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Pathologically diagnosed as prostate cancer (adenocarcinoma) 2) Unfavorable intermediate risk, high risk, and very high risk according to NCCN classification 3) PSA value is less than 100 ng/ml 4) The age on the registration date is between 20 years old and 90 years old 5) ECOG Performance status (PS) 0 to 1 6) People who can take MRI 7) Written consent has been obtained
Exclusion criteria
Exclusion criteria: (1) Patients with active overlapping cancers (excluding those with synchronous overlapping cancers expected to have a prognosis of over 5 years due to treatment or those with asynchronous overlapping cancers expected to have a prognosis of over 5 years). (2) Patients with uncontrolled diabetes (with HbA1c of 8.0% or higher as a guideline). (3) Patients deemed by their primary physician to have severe complications such as collagen diseases, heart diseases, respiratory diseases, or liver diseases. (4) Patients who have mental illness or psychiatric symptoms that make participation in the trial difficult. (5) Patients who have previously received radiation therapy to the pelvic area. (6) Patients who have undergone surgical treatment for the prostate (such as transurethral resection of the prostate, subcapsular prostatectomy, orchiectomy, etc.) or HIFU (high-intensity focused ultrasound therapy). (7) Patients who have received chemotherapy for prostate cancer other than androgen deprivation therapy. (8) Patients with inflammatory bowel diseases such as Crohn's disease and ulcerative colitis. (9) Patients for whom risk organs such as the small intestine and colon are in close proximity to the PTV estimated by imaging diagnosis, making it impossible to adhere to dose constraints. (10) Patients for whom the attending physician deems participation in clinical trials inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 8-year PSA recurrence-free survival rate | — |
Countries
Japan
Contacts
Public ContactHiromichi Ishiyama
Kitasato University school of medicine Radiation Oncology
Outcome results
None listed