Localized prostate cancer
Conditions
Interventions
Percutaneous cryosurgery to target the prostate cancer lesion
Sponsors
Kyoto Prefectural University of Medicine
Kyoto Min-iren Cyuo Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) MRI-visible single focus clinically significant cancer proven by prostate biopsy 2) T2a-T2cN0M0 3) Men aged 20-85 4) Men with informed consent
Exclusion criteria
Exclusion criteria: 1) MRI-visible biopsy proven cancer with both Gleason 6 and PI-RADS catogry 3 or with both Gleason 8 and PI-RADS catogory 5 2) PSA >20ng/ml 3) 5mm or less in distance between cancer lesion and urethral sphinctre muscle 4) Any treatment for prostate cancer in the past 5) Any anti-androgen therapy for BPH 6) Patient who use pad for urinary incontinence 7) Active cancer in other organ 8) Patient who cannot undergo MRI-prostate 9) Difficulty of undergoing transrectal ultrasonography 10) Prothrombin time<50% or platelet count <<60,000/mm3 11) Attending physician determines that the ineligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To achieve all of these 1),2), and 3): 1) 50% or greater in PSA dicrease rate from pre-op PSA to post-op PSA at post-op 3 or 6 months 2) 3 or less in PI-RADS actogry of the targeted MRI-lesion at post-op 6 months 3) Negative for cancer in the targeted prostate biopsies at post-op 6 months from the treated targeted-lesion | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient reported quality-of-life by EPIC and EQ5D questionnaires PSA change PI-RADS category change Prostate biopsy outcome (focused on Gleason score) | — |
Countries
Japan
Contacts
Public ContactOsamu Ukimura
Kyoto Prefectural University of Medicine Urology
Outcome results
None listed