Outcomes of Focal Ablation for Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 18 years — 90 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (primary setting) [Time frame: 12 months post treatment]
- Oncologic outcomes as assessed by the rate of advancement to systemic therapy or radical salvage therapies (primary setting) [Time frame: 3 years post treatment]
- Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (salvage setting) [Time frame: 12 months post treatment]
- Oncologic outcomes as assessed by the rate of progression to systemic therapy or radical salvage therapies (salvage setting) [Time frame: 3 years post treatment]
- Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (primary setting) [Time frame: Baseline and 12 months post treatment]
- Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (salvage setting) [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) [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) [Time frame: Baseline and 12 months post treatment]
Secondary outcome measures (5)
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- UTSW — Dallas
Identifiers
NCT: NCT05478694 · STU-2022-0641