Outcomes of Focal Ablation for Prostate Cancer
Status
RECRUITING
Phase
Age
18 - 90 Years
Enrollments
225Conditions
Prostate CancerSummary
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.
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Sonobia Garrett
Principal Investigator
- Xiaosong Meng, MD, PhD
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 Plan
Ablative Therapy Group
Enrolled subjects will undergo the ablative therapy as part of their standard of care treatment
Outcome Measures
Primary Outcome Measures
Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (primary setting)
Oncologic outcomes as assessed by the rate of advancement to systemic therapy or radical salvage therapies (primary setting)
Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (salvage setting)
Oncologic outcomes as assessed by the rate of progression to systemic therapy or radical salvage therapies (salvage setting)
Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (primary setting)
Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (salvage setting)
Change in erectile function as measured by International Index of Erectile Function (IIEF-5) score questionnaire (primary setting)
Change in erectile function as measured by International Index of Erectile Function (IIEF-5) score questionnaire (salvage setting)
Secondary Outcome Measures
Number of participants with adverse events or short-term complications (primary setting)
Number of participants with adverse events or short-term complications (salvage setting)
Number of participants with adverse events or long-term complications (primary setting)
Number of participants with adverse events or long-term complications (salvage setting)
Number of participants undergoing combined treatment of the transitional zone (TZ ) due to bladder outlet obstruction caused by Benign prostatic hyperplasia (BPH)
Timeline
Last Updated
March 27, 2024Start Date
July 28, 2022Today
February 5, 2025Completion Date ( Estimated )
August 1, 2026
Sponsors of this trial
Lead Sponsor
University of Texas Southwestern Medical Center
RECRUITING 
21 - 64 Years