Outcomes of Focal Ablation for Prostate Cancer
Purpose
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
- Prostate Cancer
Eligibility
- Eligible Ages
- Between 18 Years and 90 Years
- Eligible Sex
- Male
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Ablative Therapy Group | Enrolled subjects will undergo the ablative therapy as part of their standard of care treatment |
Recruiting Locations
Dallas, Texas 75390
Sonobia Garrett
More Details
- Status
- Recruiting
- Sponsor
- University of Texas Southwestern Medical Center
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.