An Evidence-Based Focal Cryotherapy Protocol for Focal Ablation of Intermediate Risk Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- Focal Cryoablation
- Conditions
- Prostate Cancer
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Quality-of-life Questionnaires
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
To learn if using cryotherapy to treat only the part of the prostate known to contain cancer is effective in controlling prostate cancer
Detailed 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 related to prostate and surrounding periprostatic fat volume. * To determine rate of progression and re-intervention collected as part of standard of care treatment for 5-year following study treatment. * To describe financial toxicity associated with focal prostate cancer treatment using cryotherapy. * To describe the incidence and severity of complications within 30-days after the study focal ablation treatment. * To describe imaging findings on PSMA PET MRI performed in a subset of men after standard of care focal cryotherapy prior to 6-month biopsy.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Focal therapy Treatment
Cryoablation is a procedure in which special needles are inserted into the tumor site.
Intervention: Focal Cryoablation
Focal therapy Treatment
Cryoablation is a procedure in which special needles are inserted into the tumor site.
Intervention: Standard of Care
Focal therapy Treatment
Cryoablation is a procedure in which special needles are inserted into the tumor site.
Intervention: Quality-of-life Questionnaires
Outcomes
Primary Outcomes
Quality-of-life Questionnaires
Time Frame: through completion an average of 1 year.
Score scale ranges (0-5) 0-Not at all/5- Almost always