Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventional

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

NCT ID: NCT06178354Sponsor: Marc Dall'Era, MDLast updated: 2024-12-16

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. 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.

Arms & interventions

  • ProcedureCryosurgery

    Undergo focal cryotherapy ablation

  • ProcedureHigh-Intensity Focused Ultrasound Ablation

    Undergo high intensity frequency ultrasound ablation

  • OtherSurvey Administration

    Ancillary studies

Outcome measures

Primary

  • Pathologic outcome on surveillance prostate biopsy

    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.

    Time frame: At year 1 and 3

  • Proportion of participants who go onto whole gland salvage treatment

    Will be estimated using the Kaplan-Meier method.

    Time frame: At 3 years

  • Salvage whole gland treatment free survival

    Will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable Cox proportional hazards models.

    Time frame: At 3 years

Secondary

  • 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

Sex: MaleAge: 18 Years and olderHealthy 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

Study locations (1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817

Recruiting
Marc Dall'Era · Contact
Marc Dall'Era · Principal Investigator
Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer | Cancerify