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

Phase 2

Recruiting

• Conditions: Prostate Cancer
• Interventions: Other: Focal Cryoablation; Other: Standard of Care; Other: Quality-of-life Questionnaires

• Registration Number: NCT05454488
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-12
• Study Start: 2022-07-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Focal therapy Treatment	Standard of Care	Cryoablation is a procedure in which special needles are inserted into the tumor site.
Focal therapy Treatment	Focal Cryoablation	Cryoablation is a procedure in which special needles are inserted into the tumor site.
Focal therapy Treatment	Quality-of-life Questionnaires	Cryoablation is a procedure in which special needles are inserted into the tumor site.

Primary Outcome Measures

Name	Time	Method
Quality-of-life Questionnaires	through completion an average of 1 year.	Score scale ranges (0-5) 0-Not at all/5- Almost always

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States