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NCT05478694 | RECRUITING | Prostate Cancer

Outcomes of Focal Ablation for Prostate Cancer
Sponsor:

University of Texas Southwestern Medical Center

Information provided by (Responsible Party):

ξ AO sends M pills

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.

Condition or disease

Prostate Cancer

Detailed Description:

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 225 participants
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
Actual Study Start Date : 2023-02-01
Estimated Primary Completion Date : 2026-08
Estimated Study Completion Date : 2026-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
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
Outcomes of Focal Ablation for Prostate Cancer

Location Details

NCT05478694

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How to Participate

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Locations

RECRUITING

United States, Texas

UTSW

Dallas, Texas, United States, 75390