Prostate Cancer
Conditions
Interventions
51.6Gy(RBE) of carbon-ion radiation in 12 fractions, 1 fraction per day, 4.3Gy(RBE) per fraction.
Sponsors
National Institutes for Quantum Science and Technology
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Histologicaly proven prostate cancer other than ductal carcinoma. 2) cT3a (UICC 7th Edition) or initial PSA>20ng/ml or Gleason score sum >=8 3) No apparent lymph node or distant metastasis confirmed by diagnostic imaging. 4) Performed neoadjuvant androgen deprivation therapy to be 3 to 12 months. 5) Performance status 0-2 (ECOG) 6) Written consent to be enrolled in this study.
Exclusion criteria
Exclusion criteria: 1) Existence of any treatment, excluding androgen deprivation therapy for prostate cancer. 2) Past history of radiotherapy which interferes with the study treatment. 3) Existence of other active malignancies (any co-existing malignancies and history of malignancy within 2 years). in-situ lesions which are concluded to be cured are not considered as such. 4) Uncontrolled infection and inflammatory disease within the irradiation field of the study treatment. 5) Psychologically and/or medically unfit for trial decided by an attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year biochemical recurrence free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| late toxicity (gastrointestinal, genitourinary), 5-year overall survival, 5-year cause specific survival, cost effectiveness, quality of life | — |
Countries
Japan
Contacts
Public ContactKana Kobayashi
National Institutes for Quantum Science and Technology QST Hospital
Outcome results
None listed