Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
225 participants
OBSERVATIONAL
2023-02-01
2026-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Ablative Therapy Group
Enrolled subjects will undergo the ablative therapy as part of their standard of care treatment
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Evidence of non-organ confined disease that is not feasible for ablation
* Has active urinary traction infection
18 Years
90 Years
MALE
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Xiaosong Meng
Assistant Professor
Principal Investigators
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Xiaosong Meng, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Locations
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UTSW
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Sonobia Garrett
Role: primary
Other Identifiers
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STU-2022-0641
Identifier Type: -
Identifier Source: org_study_id
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