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

NCT06178354 | Recruiting DMC

• 3 other identifiers: UCDCC306NCI-2023-09811P30CA093373
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

  At year 1 and 3

• Proportion of participants who go onto whole gland salvage treatment

  Will be estimated using the Kaplan-Meier method.

  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.

  At 3 years

Secondary Outcomes (4)

• Urinary function

  At 1 year

• Sexual function

  At 1 year

• Quality of life

  At 1 year

• Adverse events

  Up to end of treatment visit, approximately 7-14 days after treatment

Study Arms (1)

Treatment (cryosurgery, high intensity focused ultrasound)

EXPERIMENTAL

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

Procedure: Cryosurgery; Procedure: High-Intensity Focused Ultrasound Ablation; Other: Survey Administration

Interventions

Cryosurgery PROCEDURE

Undergo focal cryotherapy ablation

Also known as: Ablation, Cryo, Cryoablation, cryosurgical ablation

Treatment (cryosurgery, high intensity focused ultrasound)

High-Intensity Focused Ultrasound Ablation PROCEDURE

Undergo high intensity frequency ultrasound ablation

Also known as: Echopulse, Echotherapy, HIFU, High Intensity Focused Ultrasound, High Intensity Focused Ultrasound Therapy, High-intensity Focused Ultrasound, High-intensity Focused Ultrasound Therapy

Treatment (cryosurgery, high intensity focused ultrasound)

Survey Administration OTHER

Ancillary studies

Treatment (cryosurgery, high intensity focused ultrasound)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marc Dall'Era, MD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cryosurgery; High-Intensity Focused Ultrasound Ablation; Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Marc Dall'Era

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2023
• First Posted: December 21, 2023
• Study Start: November 9, 2023
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

US (1)