A Pragmatic Phase 2 Study of Focal Ablation (Focal Cryotherapy or High Intensity Frequency Ultrasound) in Men With Clinically Localized Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Pathologic outcome on surveillance prostate biopsy
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment (cryosurgery, high intensity focused ultrasound)
Patients undergo focal cryotherapy or high intensity focused ultrasound on study.
Intervention: Cryosurgery (Procedure)
Treatment (cryosurgery, high intensity focused ultrasound)
Patients undergo focal cryotherapy or high intensity focused ultrasound on study.
Intervention: High-Intensity Focused Ultrasound Ablation (Procedure)
Treatment (cryosurgery, high intensity focused ultrasound)
Patients undergo focal cryotherapy or high intensity focused ultrasound on study.
Intervention: Survey Administration (Other)
Outcomes
Primary Outcomes
Pathologic outcome on surveillance prostate biopsy
Time Frame: At year 1 and 3
Confidence intervals for the pathologic response rate will be calculated using the Wilson score method. Pathologic response rate will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable logistic regression.
Proportion of participants who go onto whole gland salvage treatment
Time Frame: At 3 years
Will be estimated using the Kaplan-Meier method.
Salvage whole gland treatment free survival
Time Frame: At 3 years
Will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable Cox proportional hazards models.
Secondary Outcomes
- Quality of life(At 1 year)
- Adverse events(Up to end of treatment visit, approximately 7-14 days after treatment)
- Sexual function(At 1 year)
- Urinary function(At 1 year)
Investigators
Marc Dall'Era, MD
Principal Investigator
University of California, Davis