localized and locally advanced prostate cancer (T1c-T4N0M0)
Conditions
Interventions
None listed
Sponsors
Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: The patient is scheduled to receive the proton radiation therapy of 51.6 GyE in 12 fractions over 3 weeks and meets the following criteria. 1. The ECOG performance status is 0-2. 2. Prostate cancer (adenocarcinoma) has been pathologically diagnosed through prostate biopsy. 3. Within 180 days of initiating treatment for prostate cancer, including hormone therapy, various examinations (physical examination, PSA measurement, pelvic MRI, chest and abdominal CT, and bone scintigraphy) have confirmed a clinical stage of T1c-4N0M0 based on the 8th edition of the TNM classification by the Union for International Cancer Control (UICC), and the risk classification according to the 2025 edition (Version 1) of the NCCN risk classification has been determined. 4. Until registration in this study, the patient has not received any treatment other than hormone therapy for prostate cancer, including surgery, radiation therapy, or chemotherapy. 5. After registration in this study, the patient is not scheduled to receive any treatment other than hormone therapy and proton radiation therapy at 51.6 GyE in 12 fractions over 3 weeks (4 sessions per week). 6. The patient has received a sufficient explanation regarding participation in this study, fully understands the details, and has provided written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Those who have active synchronous or metachronous double cancers at the time of study registration. However, carcinoma in situ, mucosal carcinoma-equivalent lesions, and skin cancer (excluding malignant melanoma) that are considered cured by appropriate treatment are not included. 2. Those with a history of surgical treatment, high-intensity focused ultrasound, or cryotherapy for the target lesion before study registration. 3. Those with a history of pelvic radiation therapy before study registration. 4. Those with a history of transurethral resection of the prostate (TUR-P) before study registration. 5. Those with a history of severe urinary dysfunction requiring catheter insertion, cystostomy, or nephrostomy within six months before study registration. 6. Those with a history of anticancer drug therapy (including chemotherapy, molecular-targeted therapy, immunotherapy, and hormone therapy) for diseases other than the target lesion within two years before study registration. This includes anticancer drug treatment for rheumatoid arthritis. 7. Those with a history of treatment with 5alpha-reductase inhibitors such as dutasteride or finasteride within two years before study registration. 8. Those who have refractory infections or inflammatory diseases in the pelvis at the time of study registration or have chronic inflammatory diseases requiring systemic treatment. 9. Those with metallic implants in the pelvic region who, according to the principal investigator or sub-investigators, are deemed unable to undergo proton beam therapy safely. 10. Those who, according to the principal investigator or sub-investigators, are deemed unsuitable for fiducial marker placement in the prostate. 11. Those who, according to the principal investigator or sub-investigators, are deemed unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade 2 or more genitourinary adverse effects evaluated based on RTOG-EORTC toxicity criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| acute genitourinary adverse event, 3-year cumulative late genitourinary adverse event, 5-year cumulative late genitourinary adverse event, acute gastrointestinal adverse event, 3-year cumulative late gastrointestinal adverse event, 5-year cumulative late gastrointestinal adverse event, biochemical recurrence-free interval, biochemical recurrence-free survival, recurrence-free survival, pattern of recurrence, disease-specific survival, overall survival, and transition of PRO (Patient-Reported Outcomes) based on HRQOL (Health-Related Quality of Life) assessment (EPIC, SF-12, IPSS, OABSS) | — |
Countries
Japan
Contacts
Public ContactNorihiro Aibe
Kyoto Prefectural University of Medicine Department of Radiology
Outcome results
None listed