Prostatic Neoplasms Prostatic Neoplasms
Conditions
Interventions
Focal HDR-BT 27 Gy/2 fr
D001918
Brachytherapy
Sponsors
Kunogi Hiroaki
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)Pathologically diagnosed prostate cancer (adenocarcinoma) 2)T1c-2cN0M0 (T2c with a maximum tumor diameter less than 50% of its prostate cross-section) 3)PSA level < 10 ng/ml 4)Grade Group 1-2 5)Low or intermediate risk (NCCN guidelines 2024) 6)One "Index tumor" obtained by magnetic resonance imaging (MRI) 7)Age at date of enrollment: 20 to 80 years old 8)ECOG Performance Status 0-1 9)Written consent 10)Preference for this study treatment rather than other standard treatments for prostate cancer (Active surveillance, surgery, external beam radiotherapy, brachytherapy)
Exclusion criteria
Exclusion criteria: 1) Other cancers 2) Uncontrolled Diabetes Mellitus 3) Severe comobidity such as collagen disease, heart disease, respiratory disease and liver disease. 4) Patient with severe psychiatric disease. 5) Previous medical history of pelvic irradiation. 6) Previous medical history of surgery or HIFU for prostate cancer. 7) Chemotherapy (except androgen deprivation therapy) for prostate cancer. 8) Inflammatory bowel disease. 9) Difficult to protect dose constraints for normal tissue. 10) Attending physician judges it is not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurence of more than or equal to Grade 3 late adverse effects in two years (erectile function, genitourinary, and gastrointestinal). (Late adverse effects: 91 days or later after radiotherapy) | — |
Secondary
| Measure | Time frame |
|---|---|
| PSA non relapse rate in 2 and 5 years Overall survival in 2 and 5 years Cause specific survival in 2 and 5 years Relapse free survival in 2 and 5 years Local relapse rate in 2 and 5 years PSA relapse free survival Overall survival time Cause specific survival time Relapse free survival time Local relapse free survival time Occurrence of acute adverse events more than or equal to Grade 2 (Genitourinary and gastrointestinal) Cumulative rate of chronic adverse events more than or equal to Grade 2 for 5 years. Dose volume analysis in study treatment Evaluation of MRIs, biopsies and post-operative pathology before and after study treatment | — |
Contacts
Public ContactHiroaki Kunogi
Department of Radiation Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research
Outcome results
None listed