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Brief Title: An Evidence-Based Focal Cryotherapy Protocol for Focal Ablation of Intermediate Risk Prostate Cancer
Official Title: An Evidence-Based Focal Cryotherapy Protocol for Focal Ablation of Intermediate Risk Prostate Cancer
Study ID: NCT05454488
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
MD Anderson Cancer Center, Houston, Texas, United States
Name: Justin Gregg, MD
Affiliation: jrgregg@mdanderson.org
Role: PRINCIPAL_INVESTIGATOR