Prostate cancer
Conditions
Interventions
Ultrahypofractionated stereotactic radiotherapy of 26 Gy in 2 fractions in 1-2 weeks using MR linear accelerator
Sponsors
National Cancer Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Histopatholologically confirmed prostate cancer. 2) Clinical stage of T1c-2cN0M0. 3) Any PSA level measured prior to enrollment is less than 20 ng/ml. 4) Gleason score of 6-7. 5) Very low/low risk or intermediate risk by NCCN guideline risk classification (2022 edition). 6) Patients with or without measurable disease. 7) Age of 18 years or older, and less than 80 years on the date of enrollment. 8) ECOG Performance status (PS) is 0 to 1. 9) No previous surgical treatment of the prostate (transurethral resection of the prostate, prostatic capsulotomy, orchiectomy, etc.), HIFU (high-intensity focused ultrasound), or chemotherapy other than hormone therapy. 10) International Prostate Symptom Score (IPSS) of 19 or less within 28 days prior to enrollment (same day of the week 4 weeks prior to enrollment is acceptable). 11) SpaceOAR is implanted in the rectal wall/prostate rather than in the Denovier space. SpaceOAR is implanted in the rectal wall/prostate, not in the Denovier space, and there is no significant worsening of urinary symptoms after implantation. 12) No prior radiation therapy within the presumable irradiation area in the present clinical trial, including treatment for other types of cancer. 13) No hormone-refractory tumors. 14) Written consent to participate in the study has been obtained from the patient. 15) The patient has been informed of other treatment options and is willing to undergo the study treatment.
Exclusion criteria
Exclusion criteria: 1) Patients have an infectious disease requiring systemic treatment. 2) Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and make it difficult for them to participate in the study. 3) Patients with diabetes mellitus that is poorly controlled despite continuous use of insulin or oral hypoglycemic agents. 4) Patient has inflammatory bowel disease such as Crohn's disease or ulcerative colitis. 5) Patient has undergone surgery in the abdominopelvic region, excluding appendicectomy and inguinal hernia. 6) Patient has active scleroderma or systemic lupus erythematosus. 7) Is considered by the investigator to be unsuitable for participation in this study. 8) Is taking anticoagulant or antiplatelet medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute genitourinary adverse events of grade 2 or higher | — |
Secondary
| Measure | Time frame |
|---|---|
| Other acute adverse event rates, 5-year rate of radiotherapy-related late adverse events (91 days or later after radiotherapy initiation), PSA nadir after radiotherapy completion, 5-year PSA recurrence-free rate, 5-year clinical progression-free rate, 5-year disease-specific survival rate, 5-year distant metastasis-free survival rate, 5-year overall survival rate, PSA recurrence-free period, clinical progression-free period, disease-specific survival, overall survival, patient-reported outcomes, and health economic evaluation using the EQ-5D. | — |
Countries
Japan
Contacts
Public ContactTairo Kashihara
National Cancer Center Hospital Depaertment of Radiation Oncology
Outcome results
None listed