An Evidence-Based Focal Cryotherapy Protocol for Focal Ablation of Intermediate Risk Prostate Cancer
M.D. Anderson Cancer Center
Summary
To learn if using cryotherapy to treat only the part of the prostate known to contain cancer is effective in controlling prostate cancer
Description
Primary Objective: • To determine the effectiveness of an evidence-based focal cryotherapy ablation by measuring negative in-field recurrence rate at 6-months post-ablation. Secondary Objectives: * To determine quality of life following focal prostate cancer ablation using validated questionnaires (EPIC-26, AUA symptoms score, SHIM). * To establish PSA kinetics post-evidence-based focal cryotherapy ablation. * To determine rates of out of field recurrence on 6-month biopsy following focal cryotherapy ablation. * To determine MRI findings post-focal cryotherapy ablation, including those rela…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion criteria: * English-speaking adult males * Life expectancy over 10 years as assessed by treating physician * Prior to enrollment, MRI fusion biopsy of MRI-visible lesion required (as detailed below, which includes systematic biopsy cores) * Single focus GG2 or GG3 (additional GG1 allowed up to 6mm, noting that a single focus of disease is defined as an area seen on MRI that may be biopsied multiple times using targeted biopsies and have systematic core biopsies directly adjacent to targeted cores; all of which being considered as from the same focus) * Histologically confirmed ad…
Interventions
- DrugFocal Cryoablation
Participants will have the Focal cryoablation placed by the needles in such a way that the area of affected tissue is much smaller and focus just on the tumor tissue and surrounding area
- OtherStandard of Care
Participants will receive a prostate biopsy.
- OtherQuality-of-life Questionnaires
Participants will fill out questionnaires.
Location
- MD Anderson Cancer CenterHouston, Texas