Outcomes of Focal Ablation for Prostate Cancer

NCT05478694 | Recruiting

• 1 other identifier: STU-2022-0641
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Focal ablation

Outcome Measures

Primary Outcomes (8)

• 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)

  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.

  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)

  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.

  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).

  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).

  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.

  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.

  Baseline and 12 months post treatment

Secondary Outcomes (5)

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

  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)

  Baseline and 12 months post treatment

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

  30 days post treatment

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

  3 years post-treatment

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

  3 years post-treatment

Study Arms (1)

Ablative Therapy Group

Enrolled subjects will undergo the ablative therapy as part of their standard of care treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with prostate cancer

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UTSW

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Daniel Segal, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonobia Garrett

CONTACT

214/645-8482; Sonobia.Garrett@UTSouthwestern.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 28, 2022
• Study Start: February 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)