prostate cancer
Conditions
Interventions
Highly-hypofractionated Dynamic WaveArc radiation therapy with simultaneous integrated boost (57 Gy/54 Gy/15 fractions/3 weeks) is applied after 6 to 12 months neoadjuvant hormonal therapy.
Sponsors
Department of Radiation Oncology & Image-applied Therapy, Kyoto University Graduate School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed as adenocarcinoma of the prostate. 2) Prostate cancer cases and diagnosed as cT2a-T3a and classified to high-risk based on MRI, CT and bone scintigraphy before the initiation of neoadjuvant hormonal therapy. 3) Neoadjuvant hormonal therapy is performed. 4) Age at the registration is >=50 and <80 years old. 5) Performance status is 0 or 1 with Eastern Cooperative Oncology Group definition. 6) Cases submitted a written informed consent. 7) The basic blood examinations, including serum prostate-specific antigen (PSA) level was performed before the initiation of neoadjuvant hormonal therapy.
Exclusion criteria
Exclusion criteria: 1) cT3a, iPSA >=30 ng/ml, and GS >= 4+4 2) active double cancer (i.e., overlapping cancer or asynchronous cancer within 5 years, except carcinoma in situ, intramucosal cancer, and other equivalent lesions) 3) Uncontrolled diabetes mellitus (HbA1c>+8.4%) 4) Severe coexisting diseases such as collagen disease, heart disease, respiratory disease and liver disease. 5) Psychotic disease 6) History of pelvic irradiation 7) History of pelvic surgery except for appendectomy and femoral herniation. 8) Surgical managements to the prostate 9) Chemotherapy to the prostate cancer 10) Inflammatory bowel diseases 11) Cases who are difficult to discontinue the administration of anticoagulant drugs. 12) Cases who are considered difficult to achieve dose constrain because of risk organs. 13) Cases with diffuse or large prostatic lesions. 14) Cases with significant metal artifact on pelvic CT images. 15) Cases who are difficult to achieve dose constrain at treatment planning.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidences of acute adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidences of late adverse events at 2 years PSA recurrence-free suravival rate at 2 years | — |
Countries
Japan
Contacts
Public ContactTakashi Mizowaki
Kyoto University Graduate School of Medicine Department of Radiation Oncology and Image-applied Therapy
Outcome results
None listed