Recruiting

Outcomes of Focal Ablation for Prostate Cancer

NCT05478694 · University of Texas Southwestern Medical Center

Recruiting

In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title

Prospective Single Institutional Study Evaluating the Outcomes for Patients Undergoing Ablative Therapies in the Management of Clinically Localized Prostate Cancer in the Primary and Salvage Setting

About this study

This study will be designed to define the efficacy and safety of ablative therapies in the management of localized prostate cancer and comprehensively evaluate quality of life outcomes and oncologic control following treatment. There are several commercially available standard of care treatments available for local therapy of the prostate. Ablative therapies may be delivered via a whole gland or focal approach by systems including cryoablation (CA), brachytherapy, irreversible electroporation (IRE), high intensity focused ultrasound (HIFU), MRI-guided transurethral ultrasound ablation (TULSA) procedure or future novel prostate ablation systems. These are single, outpatient treatments lasting between 2-4 hours and include treatment planning and energy delivery under guidance and are either administered via transperineally approach (cryoablation, IRE, brachytherapy) or via the urethral (TULSA-Pro) or rectum (HIFU). This study protocol will not include experimental therapy and the enrolled subjects will undergo the ablative therapy as part of their standard of care treatment.

Eligibility criteria

Inclusion Criteria: * Men with histologically confirmed prostate adenocarcinoma diagnosed on prostate biopsy * Men with histologically confirmed local recurrence of prostate cancer diagnosed on prostate biopsy and standard of care imaging excluding locoregional or metastatic disease * Age 18-90 years. * Life expectancy \> 1 year * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * Anatomic abnormalities that do not allow for focal ablation * Evidence of non-organ confined disease that is not feasible for ablation * Has active urinary traction infection

Study design

Enrollment target: 225 participants

Age groups: adult, older_adult

Timeline

Starts: 2023-02-01

Estimated completion: 2026-08

Last updated: 2026-04-17

Primary outcomes

• Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (primary setting) (12 months post treatment)
• Oncologic outcomes as assessed by the rate of advancement to systemic therapy or radical salvage therapies (primary setting) (3 years post treatment)
• Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (salvage setting) (12 months post treatment)

Sponsor

University of Texas Southwestern Medical Center · other

Contacts & investigators

ContactSonobia Garrett · contact · Sonobia.Garrett@UTSouthwestern.edu · 214/645-8482

InvestigatorDaniel Segal, M.D. · principal_investigator, University of Texas Southwestern Medical Center

All locations (1)

UTSWRecruiting

Dallas, Texas, United States

View on ClinicalTrials.gov ↗Find similar trials