prostate cancer
Conditions
Interventions
1st dose level (7 Gy x 5 fractions = 35 Gy), 2nd dose level (7.5 Gy x 5 fractions = 37.5 Gy), 3rd dose level (8 Gy x 5 fractions = 40 Gy)
Sponsors
Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Biopsy-proven adenocarcinoma 2) no lymph node metastasis or distant metastasis proven by all of MRI, CT and bone scan 3) T1c-T2cN0M0 4) GS <=7 5) PSA <=20 6) No hormone therapy or less than 1-year neoadjuvant hormone therapy 7) WBC>3,000, Hb >10, Plt >10000, Cr <2, GOT <100, GPT<100 8) Age >20, <80 9) Informed consent
Exclusion criteria
Exclusion criteria: 1) Active double cancer 2) Uncontrollable DM 3) Impossible to stop anticoagulate drugs 4) Severe brain disease 5) Collagen disease 6) Previous pelvic surgery or radiotherapy 7) Previous TUR-P 8) Severe BPH or dysuria 9) Disagree to implant of metallic marker 10) Hormone therapy > 1 year 11) Castration-resistant prostate cancer 12) PSA >20 13) Physician-rated contraindication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of 2-year late adverse events (genitourinary and gaastrointestinal Grade 2 or more) | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year biochemical control rate, QOL questionnaire (EPIC + SF-8), dosimetry (dose distribution etc. in radiation physics) | — |
Countries
Japan
Contacts
Public ContactTakero Hirata
Osaka University Graduate School of Medicine Radiation Oncology
Outcome results
None listed