Prostate CancerNCT05478694
Outcomes of Focal Ablation for Prostate Cancer
An observational study of Prostate Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with prostate cancer
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UTSW
Dallas, Texas, 75390
Sonobia Garrett
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Keywords
- Focal ablation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ablative Therapy Group | Enrolled subjects will undergo the ablative therapy as part of their standard of care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline and 12 months post treatment
Secondary outcomes (5)
Number of participants with adverse events or short-term complications (primary setting)
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
Measured: 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)
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
Measured: Baseline and 12 months post treatment
Number of participants with adverse events or short-term complications (salvage setting)
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
Measured: 30 days post treatment
Number of participants with adverse events or long-term complications (primary setting)
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
Measured: 3 years post-treatment
Number of participants with adverse events or long-term complications (salvage setting)
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
Measured: 3 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Feb 2023
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Segal, University of Texas Southwestern Medical Center
- Investigators
- Daniel Segal, M.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478694
- Sponsor's protocol ID
- STU-2022-0641
- Status last verified
- Apr 2026
- First submitted
- 25 Jul 2022
- Last updated
- 17 Apr 2026
- Results posted
- No
- Individual data sharing
- Yes: We will plan on sharing patient demographics, treatment modality, treatment oncologic outcomes, post-treatment questionnaire data and adverse events. Specific patient identifiers will be removed.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05478694
- Acronym / sponsor ID
- STU-2022-0641
- Conditions
- Prostate Cancer
- Keywords
- Focal ablation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablative Therapy Group | – | –Enrolled subjects will undergo the ablative therapy as part of their standard of care treatment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with prostate cancer
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Yes. We will plan on sharing patient demographics, treatment modality, treatment oncologic outcomes, post-treatment questionnaire data and adverse events. Specific patient identifiers will be removed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Segal, M.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sonobia Garrett (214/645-8482, Sonobia.Garrett@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (primary setting) (time frame: 12 months post treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.