Recruiting

Focal Ablation

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT05478694

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT05478694

Start date

Feb 1, 2023

Status verified date

Apr, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

225 participants

Anticipated

Interventions and Outcome Measures

Arms

Ablative Therapy Group

Enrolled subjects will undergo the ablative therapy as part of their standard of care treatment

Primary outcome measure

  • Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (primary setting) [ Time Frame: 12 months post treatment ]
  • Oncologic outcomes as assessed by the rate of advancement to systemic therapy or radical salvage therapies (primary setting) [ Time Frame: 3 years post treatment ]
  • Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (salvage setting) [ Time Frame: 12 months post treatment ]
  • Oncologic outcomes as assessed by the rate of progression to systemic therapy or radical salvage therapies (salvage setting) [ Time Frame: 3 years post treatment ]
  • Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (primary setting) [ Time Frame: Baseline and 12 months post treatment ]
  • Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (salvage setting) [ Time Frame: Baseline and 12 months post treatment ]
  • Change in erectile function as measured by International Index of Erectile Function (IIEF-5) score questionnaire (primary setting) [ Time Frame: Baseline and 12 months post treatment ]
  • Change in erectile function as measured by International Index of Erectile Function (IIEF-5) score questionnaire (salvage setting) [ Time Frame: Baseline and 12 months post treatment ]

Central Contacts and Locations

Central contacts

Sonobia Garrett

214/645-8482Sonobia.Garrett@UTSouthwestern.edu

Locations

UTSW

Recruiting

Dallas, Texas, United States, 75390

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

  • Focal ablation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-04-17.