Prostate cancer
Conditions
Interventions
Sponsors
Department of Radiation Medicine, Hokkaido University Graduate School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Pathologically proven adenocarcinoma of the prostate 2) ECOG-PS 0-2 3) Age 20-yrs old or over at the time of consent form is obtained 4) Well informed and documented consent from the patient
Exclusion criteria
Exclusion criteria: 1) Pathologically proven non-adenocarcinoma or mixed type adenocarcinoma of the prostate 2) Clinically obvious lymph node or distant metastasis 3) With active other cancers 4) With severe uncontrolled diabetes 5) With severe heart disease, or some serious complications, i.e., SLE, Scleroderma 6) With an inflammatory bowel syndrome, i.e., Crohn's disease, ulcerative colitis 7) Previous surgical treatment or High-intensity focused ultrasound (HIFU) for prostate 8) Previous chemotherapy for prostate cancer before enrollment 9) Previous surgery to pelvis, except for appendectomy 10) Previous radiotherapy to pelvis 11) With implantable cardioverter defibrillator or permanent pacemaker 12) Allergic to radiation 13) Considered that participation in this trial is difficult because of psychiatric symptoms or psychosis 14) Cannot be held rest for about 30 minutes 15) Cannot be implanted Au marker in the prostate 16) Weight over 135 kg 17) Unsuitable for enrollment judged by principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of early adverse effects within 90 days after real-time tumor-tracking proton beam therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse free survival, incidence of adverse effect of Grade 3 or higher and cost-effectiveness at 18 months, incidence of dropout and migration of Au markers during treatment period | — |
Countries
Japan
Contacts
Public ContactShinichi Shimizu
Hokkaido University Graduate School of Medicine Department of Radiation Medicine
Outcome results
None listed