prostate cancer
Conditions
Interventions
Sponsors
Nara Medical University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1, patients with prostate cancer who undergo low-dose-brachytherapy 2, Gleason score 3+3 or 3+4, the number of positive core on hemi lobe by prostate biopsy (8-12 cores) 3, PSA < 10ng/mL 4, cT1 or cT2a on MRI 5, no metastatic findings on bone scintigraphy, MRI, and CT 6, >20, <85 years old
Exclusion criteria
Exclusion criteria: 1, Patients who underwent TUR-P 2, Patients with pubic arch interference 3, history of androgen deprivation therapy 4, severe mental disorders 5, systemic and continuous use of steroidal drugs 6, history of radiation therapy on pelvis 7, inflammatory bowel disease 8, severe diabetes 9,patients who have difficulty to hold operative position 10, abnormal findings on blood examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change at 3 months after focal brachytherapy (FBT) from baseline in the mean 24 h urinary frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| 1, PSA value before FBT, and at 1,3,6,12,18,24,30,and 36 months after FBT. 2, biochemical failure free survival by Stuttgart definition (PSA nadir + 1.2ng/ml) 3, biochemical failure free survival by Phenix definition (PSA nadir + 2.0ng/ml) 4,pathological findings by saturation biopsy 36 months after FBT 5,findings on MRI 36months after FBT 6,radical treatment free suvival 7,the change at 1,3,6,12,18,24,30,and 36 months after FBT from baseline in IPSS, OABSS, QOL, SHIM, SF-8, and EPIC 8, the change at 1,3,6,and 12 months after FBT from baseline in mean volume voided per micturition, the change at 1,6,and 12 months after FBT from baseline in the mean 24 h urinary frequency 9, the change at 1,3,6,12,18,24,30, and 36months after FBT from baseline in post-voiding residual volume 10, Genitourinary and gastrointestional toxicity (CTCAE version 5.0) 11, comparison of chronological change of PSA between patients with positive findings on saturation biopsy at 36 months after FBT and those with negative findings 12,comparison with historical data (patients who underwent low-dose-rate brachytherapy between May 2010 and April 2020) in the change of IPSS, OABSS, QOL, SHIM, SF-8, EPIC, the mean 24h urinary frequency, mean volume voided per micturition, and toxicity. | — |
Countries
Japan
Contacts
Public ContactNakai Yasushi
Nara Medical University Department of Urology
Outcome results
None listed