Focal cryotherapy for prostate cancer

Phase 2

Recruiting

• Conditions: Prostate cancer; Prostate cancer, cryotherapy, focal therapy

• Registration Number: JPRN-jRCTs032180392
• Lead Sponsor: Kimura Takahiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

1, Primary prostate cancer
1) Gleason score, under 7
2) PSA, under 20 ng/ml
3) Patient who has targeted region with PIRADS score 3 or more by MRI
4) Clinically significant cancer proven by MRI/US fusion biopsy and MRI imaging
5) Gleason score of cancer(s) detected by transperineal saturation biopsy except for targeted lesion is 6 or lower
6) No positive findings except for targeted lesion by MRI
7) Clinical T stage, under T3a
8) PS 0,1 .
2, Local recurrence prostate cancer after definitive radiotherapy
1) Patient with local recurrence prostate cancer detected by MRI and biopsy
2) Cancers except for targeted lesion is negative on MRI and biopsy Gleason score by transperineal saturation biopsy is Gleason score 7 or lower
3) No distant metastasis
4) PSA, under 20 ng/ml
5) PS 0,1

Exclusion Criteria

1) Patient with active multiple cancers
2) Patient having uncontrolled hypertension, diabetes and ischemic cardiac disease
3) Patient using steroidal agents
4) Patient having hormone therapy within 3 months from consented day.
5) Patient to whom participating physicians judged to be inappropriate for this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biochemical recurrence free survival

Secondary Outcome Measures

Name	Time	Method
(1)Overall survival<br>(2)Clinical progression free survival<br>(3)Prostate cancer specific survival<br>(4)Salvage treatment free survival<br>(5)biopsy results<br>(6)Adverse events<br>(7)QOL analysis