Prostate cancer
Conditions
Interventions
Moderately hypo-fractionated intensity modulated radiation therapy (63Gy in 21 fractions) with concurrently administration of daikenchuto
Sponsors
Suita Tokushukai Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Patients eligible for radical intensity modulated radiation therapy (localized irradiation to the prostate + seminal vesicles) for prostate cancer 2) Male patients aged 20 years or older at the time of informed consent 3) Patients with an ECOG PS score of 2 or less who are able to visit the outpatient clinic 4) Research subjects who have given their own free written consent after receiving sufficient explanation to participate in this research
Exclusion criteria
Exclusion criteria: 1)Patients with a history of active multiple cancers 2) Patients who are suitable for radical intensity-modulated radiotherapy for prostate cancer, but who are judged to require combination therapy with pelvic irradiation due to pelvic lymph node metastases 3)Patients who have undergone pelvic radiation therapy before obtaining consent 4)Patients who have been taking regular Chinese herbal medicines including Daikenchuto since before consent was obtained 5) Patients who are already known to be allergic to Daikenchuto and the herbal medicines contained in this drug 6) Patients who are unable to collect urine during radiotherapy due to co-morbidities such as hemodialysis 7) Patients who are self-catheterized or have a urinary catheter continuously in place due to urinary retention or severe urinary difficulty as a comorbidity 8) Patients with a history of inflammatory bowel disease such as ulcerative colitis or Crohn's disease as a comorbidity 9)Patients with persistent lower gastrointestinal bleeding symptoms due to hemorrhoids etc. as a comorbidity 10)Patients with interstitial pneumonia as a comorbidity 11)Patients with collagen disease as a comorbidity 12) Patients with serious liver disease (AST (GOT) or ALT (GPT) 100 U/L or more) 13) Patients with severe renal disease (creatinine 2.0 mg/dl or more) 14)Other patients deemed unsuitable as research subjects by the research director
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year rate of radiotherapy-related late gastrointestinal adverse events : rate of rectal bleeding due to radiation proctitis | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year and 5-year rate of radiotherapy-related late adverse events, 3-year and 5-year biological recurrence-free rate, 3-year and 5-year overall survival rate, patient-reported outcomes, and QOL evaluation using the IPSS and EPIC. | — |
Countries
Japan
Contacts
Public ContactMasateru Fujiwara
Suita Tokushukai Hospital Depaertment of Radiation Oncology
Outcome results
None listed