Observational Study of Focal Ablation for Prostate Cancer
This study is looking at how well different focal ablation treatments work for men with prostate cancer. These treatments, which include cryoablation (freezing), brachytherapy (radiation), irreversible electroporation (electrical pulses), high intensity focused ultrasound (HIFU), and MRI-guided transurethral ultrasound ablation (TULSA), are already available as standard care. Researchers want to see how effective these treatments are at controlling cancer and how they impact your quality of life. To join, you must be a man between 18 and 90 years old with prostate cancer that has been confirmed by a biopsy. The study aims to enroll 225 participants. Success will be measured by how many men have negative biopsies 12 months after treatment and how many need more intense treatments within 3 years. The current status of this study is unclear.
- Study design
- This is an observational study, meaning participants will receive standard care treatments. It aims to enroll 225 men.
- What's involved
- Participants will undergo a single, outpatient ablative therapy lasting 2-4 hours, including treatment planning and energy delivery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 12 months, with some outcomes measured up to 3 years after treatment.
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Outcomes of Focal Ablation for Prostate Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Daniel Segal, M.D. · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (primary setting)12 months post treatment
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)
- Oncologic outcomes as assessed by the rate of advancement to systemic therapy or radical salvage therapies (primary setting)3 years post treatment
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.
- Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (salvage setting)12 months post treatment
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)
- Oncologic outcomes as assessed by the rate of progression to systemic therapy or radical salvage therapies (salvage setting)3 years post treatment
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.
- Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (primary setting)Baseline and 12 months post treatment
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).
- Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (salvage setting)Baseline and 12 months post treatment
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).
- Change in erectile function as measured by International Index of Erectile Function (IIEF-5) score questionnaire (primary setting)Baseline and 12 months post treatment
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.
- Change in erectile function as measured by International Index of Erectile Function (IIEF-5) score questionnaire (salvage setting)Baseline and 12 months post treatment
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.