Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer
Status
RECRUITING
Phase
NA
Age
≥ 18 Years
Enrollments
100Conditions
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 v8Summary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Marc Dall'Era
- 916-734-3772
- [email protected]
Principal Investigator
- Marc Dall'Era
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
Study Plan
Treatment (cryosurgery, high intensity focused ultrasound)
EXPERIMENTAL
Patients undergo focal cryotherapy or high intensity focused ultrasound on study.
PROCEDURE:
CryosurgeryDescription:
Undergo focal cryotherapy ablationPROCEDURE:
High-Intensity Focused Ultrasound AblationDescription:
Undergo high intensity frequency ultrasound ablationOTHER:
Survey AdministrationDescription:
Ancillary studies
Outcome Measures
Primary Outcome Measures
Pathologic outcome on surveillance prostate biopsy
Proportion of participants who go onto whole gland salvage treatment
Salvage whole gland treatment free survival
Secondary Outcome Measures
Urinary function
Sexual function
Quality of life
Adverse events
Timeline
Last Updated
December 21, 2023Start Date
December 21, 2023Today
February 5, 2025Completion Date ( Estimated )
June 1, 2029
Sponsors of this trial
Lead Sponsor
Marc Dall'Era, MDCollaborating Sponsors
National Cancer Institute (NCI)
RECRUITING 
21 - 64 Years