Status:
ACTIVE_NOT_RECRUITING
Phase II Trial of Focal Cryotherapy for Prostate Cancer
Lead Sponsor:
Singapore General Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
NA
Brief Summary
The current standard of care treatment for prostate cancer confined to the prostate is surgical removal or irradiation of the entire prostate gland. This is effective at curing cancer but result in da...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- PSA (prostate specific antigen) ≤ 20
- Biopsy Gleason score ≤ 4+4
- mpMRI shows no gross extracapsular extension
- mpMRI shows index lesion volume \< 3 ml
- ≤ 2 biopsy confirmed lesions on mpMRI
- Exclusion criteria:
- American Society of Anesthesiologist score \>3
- Very high grade cancer (Gleason score \> 4+4)
- \>2 index lesions
- Multifocal cancer (any other Gleason \>3+3 present and/or Gleason 3+3 at \> 3 biopsy cores at another site) - Not eligible for mpMRI
- Not fit for robotic transperineal saturation biopsy
Exclusion
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2041
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04138914
Start Date
March 1 2019
End Date
March 1 2041
Last Update
April 4 2023
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, 168753