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
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.
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.
Arms & interventions
Outcome measures
Primary
Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (primary setting)
Oncologic outcomes will be assessed by the rate of negative in-field biopsy at 12 months which is defined by the Delphi consensus criterion of absence of clinically significant disease (≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is insignificant)
Time frame: 12 months post treatment
Oncologic outcomes as assessed by the rate of advancement to systemic therapy or radical salvage therapies (primary setting)
Oncologic outcomes will be assessed by the rate of advancement to systemic therapy or radical salvage therapies which is defined by prostatectomy, radiation or hormone therapy.
Time frame: 3 years post treatment
Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (salvage setting)
Oncologic outcomes will be assessed by the rate of negative in-field biopsy at 12 months which is defined by the Delphi consensus criterion of absence of clinically significant disease (≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is insignificant)
Time frame: 12 months post treatment
Oncologic outcomes as assessed by the rate of progression to systemic therapy or radical salvage therapies (salvage setting)
Oncologic outcomes will be assessed by the rate of progression to systemic therapy or radical salvage therapies which is defined by prostatectomy, radiation or hormone therapy.
Time frame: 3 years post treatment
Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (primary setting)
Change in urinary function is measured by International Prostate Symptom Score (IPSS) questionnaire which measures urinary symptoms and continence and the scores range from 0 to 35. A change \> 3 points between baseline and follow-up assessments is defined as meaningful for the IPSS. Therefore, increases in IPSS scores larger than 3 points will be categorized as reduced urinary function (worse outcome).
Time frame: Baseline and 12 months post treatment
Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (salvage setting)
Change in urinary function is measured by International Prostate Symptom Score (IPSS) questionnaire which measures urinary symptoms and continence and the scores range from 0 to 35. A change \> 3 points between baseline and follow-up assessments is defined as meaningful for the IPSS. Therefore, increases in IPSS scores larger than 3 points will be categorized as reduced urinary function (worse outcome).
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)
Change in erectile function is measured by International Index of Erectile Function (IIEF-5) score questionnaire which classifies patients into five severity levels ranging from none (22-25 points) to severe (5-7 points). Patients whose IIEF-5 levels worsen from baseline to follow-up will be categorized as having reduced erectile function.
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)
Change in erectile function is measured by International Index of Erectile Function (IIEF-5) score questionnaire which classifies patients into five severity levels ranging from none (22-25 points) to severe (5-7 points). Patients whose IIEF-5 levels worsen from baseline to follow-up will be categorized as having reduced erectile function.
Time frame: Baseline and 12 months post treatment
Secondary
Number of participants with adverse events or short-term complications (primary setting)
Time frame: 30 days post treatment
Number of participants undergoing combined treatment of the transitional zone (TZ ) due to bladder outlet obstruction caused by Benign prostatic hyperplasia (BPH)
Time frame: Baseline and 12 months post treatment
Number of participants with adverse events or short-term complications (salvage setting)
Time frame: 30 days post treatment
Number of participants with adverse events or long-term complications (primary setting)
Time frame: 3 years post-treatment
Number of participants with adverse events or long-term complications (salvage setting)
Time frame: 3 years post-treatment
Eligibility criteria
Study locations (1)
UTSW
Dallas, Texas, 75390