Outcomes of Focal Ablation for Prostate Cancer

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 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.