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NCT Number: NCT05478694

Outcomes of Focal Ablation for Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–90 year

Sex eligibility

Male

Study type

Observational

Primary location

UTSW

Dallas, Texas, 75390, United States

Location status: Recruiting

Location contact

Sonobia Garrett

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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.

  3. 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)

  4. 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.

  5. 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).

  6. 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).

  7. 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.

  8. 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.

Secondary outcomes

  1. Number of participants with adverse events or short-term complications (primary setting)

    Time frame: 30 days post treatment

    Adverse events (AE)s will be monitored and evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for 30 days post-treatment

  2. 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 undergoing combined treatment of the transitional zone (TZ ) due to bladder outlet obstruction caused by BPH will be evaluated to determine efficacy of treatment of the transitional zone in patients with lower urinary tract symptoms (LUTS) due to BPH via International Prostate Symptom Score (IPSS) questionnaire

  3. Number of participants with adverse events or short-term complications (salvage setting)

    Time frame: 30 days post treatment

    Adverse events (AE)s will be monitored and evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for 30 days post-treatment

  4. Number of participants with adverse events or long-term complications (primary setting)

    Time frame: 3 years post-treatment

    An adverse event (AE) will be monitored and evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for up to 3 years post-treatment

  5. Number of participants with adverse events or long-term complications (salvage setting)

    Time frame: 3 years post-treatment

    An adverse event (AE) will be monitored and evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for up to 3 years post-treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Sonobia Garrett

CONTACT

[email protected]

214/645-8482

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2022
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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