An Evidence-Based Focal Cryotherapy Protocol for Focal Ablation of Intermediate Risk Prostate Cancer

Prostate Cancer Clinical Trial

Official title: An Evidence-Based Focal Cryotherapy Protocol for Focal Ablation of Intermediate Risk Prostate Cancer

Status Recruiting

Clinical Trial Summary

To learn if using cryotherapy to treat only the part of the prostate known to contain cancer is effective in controlling prostate cancer

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT05454488
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Contact: Justin Gregg, MD
• Phone: 713-792-3250
• Email: jrgregg@mdanderson.org
• Status: Recruiting
• Phase: Phase 2
• Start date: July 25, 2022
• Completion date: January 31, 2026