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Recruiting NCT06178354

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

No phase Interventional Localized Prostate Carcinoma Stage I Prostate Cancer AJCC v8 Stage II Prostate Cancer AJCC v8 Stage IIIA Prostate Cancer AJCC v8

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cryosurgery, High-Intensity Focused Ultrasound Ablation, Survey Administration.
Who it may be relevant to
Registry conditions: Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pragmatic Phase 2 Study of Focal Ablation (Focal Cryotherapy or High Intensity Frequency Ultrasound) in Men With Clinically Localized Prostate Cancer

Overview

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.

Detailed description

PRIMARY OBJECTIVE:

I. To determine the efficacy of focal therapy for treatment of prostate cancer.

SECONDARY OBJECTIVES:

I. Patient reported urinary, sexual function and quality of life (QOL) at 1 year.

II. To assess safety.

OUTLINE:

Patients undergo focal cryotherapy or high intensity focused ultrasound on study.

After completion of study treatment, patients are followed up at 7-14 days and periodically for up to 3 years.

Interventions

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

Primary outcome measures

  • Pathologic outcome on surveillance prostate biopsy [Time frame: At year 1 and 3]
  • Proportion of participants who go onto whole gland salvage treatment [Time frame: At 3 years]
  • Salvage whole gland treatment free survival [Time frame: At 3 years]
Secondary outcome measures (4)
  • Urinary function [Time frame: At 1 year]
  • Sexual function [Time frame: At 1 year]
  • Quality of life [Time frame: At 1 year]
  • Adverse events [Time frame: Up to end of treatment visit, approximately 7-14 days after treatment]

Eligibility criteria

Inclusion criteria

  • Ability to understand and willingness to sign an informed consent form
  • Clinically localized grade group 1, 2, or 3 prostate cancer and unilateral magnetic resonance imaging (MRI) visible lesion(s). Up to 3 lesions will be allowed for focal treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky ≥ 70%)
  • Patients ≥ 18 years of age at time of consent
  • Life expectancy ≥ 5 years
  • Ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study

Exclusion criteria

  • Nodal or distant metastases
  • Prior treatment for prostate cancer
  • Anticipated treatment with any cancer intervention, including radiation, hormonal therapy or surgery ≤ 6 months prior to focal therapy in this study
  • Known contraindications to general anesthesia
  • Uncorrectable coagulopathy
  • Significant active cardiac disease within the previous 6 months including: New York Heart Association (NYHA) class 4 congestive heart failure (CHF), unstable angina, or myocardial infarction
  • Any condition that would prohibit the understanding or rendering of informed consent
  • Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of California Davis Comprehensive Cancer Center — Sacramento

Identifiers

NCT: NCT06178354 · UCDCC306 · NCI-2023-09811 · UCDCC306 · P30CA093373

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗