Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT06178354
Status
Recruiting

Conditions

  • Localized Prostate Carcinoma
  • Stage I Prostate Cancer AJCC v8
  • Stage II Prostate Cancer AJCC v8
  • Stage IIIA Prostate Cancer AJCC v8
  • Stage IIIB Prostate Cancer AJCC v8

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cryosurgery — PROCEDURE
    Undergo focal cryotherapy ablation
  • High-Intensity Focused Ultrasound Ablation — PROCEDURE
    Undergo high intensity frequency ultrasound ablation
  • Survey Administration — OTHER
    Ancillary studies

Study Details

This clinical trial evaluates the effectiveness of focal ablation with either focal cryotherapy or high intensity frequency ultrasound for the treatment of men with localized prostate cancer. Focal cryotherapy kills tumor cells by freezing them. High intensity frequency ultrasound uses highly focused ultrasound waves to produce heat and destroy tumor cells.

Key Dates

First listed
Dec 21, 2023
Start date
Nov 9, 2023
Status verified
Jun 2026
Primary completion
Nov 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (cryosurgery, high intensity focused ultrasound)
    Patients undergo focal cryotherapy or high intensity focused ultrasound on study.

Primary Outcome Measure

Pathologic outcome on surveillance prostate biopsy [ Time Frame: At year 1 and 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Office of Clinical Research
916-382-6970
Marc Dall'Era (PRINCIPAL_INVESTIGATOR)

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