Localized Prostate CancerSONAFUSIONNCT07757490
Sonablate HIFU International Registry for PC & BPH Patients
An observational study of Localized Prostate Cancer and BPH (Benign Prostatic Hyperplasia), run by Sonablate at 1 site in United States.
Trial summary
The SONA FUSION Registry is an observational study designed to evaluate the long-term effectiveness and safety of the Sonablate High-Intensity Focused Ultrasound (HIFU) system. This study focuses on adult men who have been treated for localized prostate cancer, benign prostatic hyperplasia (BPH) with urinary symptoms… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Localized Prostate Cancer, BPH (Benign Prostatic Hyperplasia), Prostate Cancer; Benign Prostatic Hyperplasia
- What is being tested?
- High Intensity Focused Ultrasound
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2015to Dec 2035
- How long will I take part?
- 10 Years
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult biological males (≥18 years) diagnosed with localized prostate cancer and/or benign prostatic hyperplasia (BPH) with lower urinary tract symptoms (LUTS), who have undergone Sonablate HIFU ablation strictly as part of routine standard clinical care
Who may be able to join
- Male with diagnosed localized prostate cancer or BPH (benign prostatic hyperplasia)
- Having undergone Sonablate HIFU ablation as part of standard clinical care, with all central data transmission subject to a mandatory 180-day post-procedure delay.
Who cannot join
- Prostate size or lesion location precluding effective HIFU target acquisition (prostate volume >100 CC for prostate cancer or >80 CC for BPH)
- Confirmed metastatic prostate cancer
- Prior radical prostatectomy
- Prostates with large calcifications (>10mm causing shadowing)
- Prior rectal wall surgery or inability to undergo transrectal ultrasound
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
Indiana University Medical Center
Indianapolis, Indiana, 46202
Clint D. Bahler, MD, 317-944-3458, cdbahler@iu.edu
About this study
Official title: SONAFUSION Registry (Long-term Evaluation of Sonablate High-Intensity Focused Ultrasound for the Treatment of Prostate Cancer and Benign Prostatic Hyperplasia)
The SONA FUSION Registry is an observational study designed to evaluate the long-term effectiveness and safety of the Sonablate High-Intensity Focused Ultrasound (HIFU) system. This study focuses on adult men who have been treated for localized prostate cancer, benign prostatic hyperplasia (BPH) with urinary symptoms, or a combination of both conditions. The registry collects real-world medical data from multiple clinics globally to better understand how well the HIFU treatment controls disease and affects urinary and sexual function over a 10- to 20-year period.
The study includes two groups of participants: a retrospective group of patients who previously received treatment, and a prospective group of newly treated patients receiving standard clinical care. No experimental interventions are assigned for the purpose of this study. To protect participant privacy, all medical data is completely de-identified and stripped of direct identifiers before being securely transferred to the central coordinating center at Indiana University. The ultimate goal of this research is to improve patient care protocols, advance men's health knowledge, and establish evidence-based guidelines for minimally invasive prostate treatments.
Read the detailed description
Traditional surgical interventions for prostate cancer and benign prostatic hyperplasia (BPH) are often associated with significant morbidity. While high-intensity focused ultrasound (HIFU) has emerged as a recognized, minimally invasive alternative, existing clinical evidence often lacks prospective, long-term follow-up and standardized, validated outcome assessments.
To systematically track and evaluate these standard-of-care interventions, the SONA FUSION Registry serves as a central repository for the consolidation of real-world clinical data from leading academic and clinical centers globally. The registry is designed to refine HIFU treatment protocols, improve patient counseling practices, and establish evidence-based scientific foundations for the standardized adoption of robotic HIFU technology.
The central repository at Indiana University receives and maintains exclusively de-identified research data. The protocol structurally prevents re-identification by mandating the permanent removal of all direct identifiers at the local site level prior to transmission. Furthermore, clinical dates are strictly protected via temporal masking, converting all temporal data to relative study days-and a non-negotiable 180-day post-procedure delay is enforced before any prospective data is authorized for abstraction.
To continuously validate these safeguards, an independent Honest Broker conducts an annual audit of a 20 percent sample of the database, ensuring the central research team remains definitively blinded to all patient identifiers.
- Conditions
- Localized Prostate Cancer, BPH (Benign Prostatic Hyperplasia), Prostate Cancer; Benign Prostatic Hyperplasia
- Being tested
- High Intensity Focused Ultrasound
- Keywords
- HIFU, LOFU, High Intensity Focused Ultrasound, Sonablate, Directional Compression, Bolus Guide, prostate cancer, BPH, Histoblast, Sonatripsy, High-Intensity Focused Ultrasound, HIFU, Sonablate, Lower Urinary Tract Symptoms, Minimally Invasive, Prostate Ablation
- Medical subject headings
- Prostatic Hyperplasia, Prostatic Neoplasms, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Focused UltrasoundDevice
Use of high intensity focused utrasound and sonatripsy for thermal and mechanical tissue ablation
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort | Historical, fully de-identified clinical data from patients treated for localized prostate cancer or BPH who underwent Sonablate HIFU ablation as part of standard clinical care. Receives: Device: High Intensity Focused Ultrasound | |
| Prospective Cohort | Newly treated prostate cancer or BPH patients undergoing Sonablate HIFU ablation as part of standard clinical care, subject to a mandatory 180-day post-procedure data abstraction delay. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical and Histological Recurrence-Free Survival Rate
Proportion of patients remaining free of clinically significant prostate cancer recurrence in the treated area, evaluated via standard-of-care Prostate Specific Antigen (PSA) testing, multiparametric MRI, and/or follow-up prostate biopsy.
Measured: Baseline, and annually up to 10 years
Secondary outcomes (6)
Change in International Prostate Symptom Score (IPSS) / AUA Symptom Score
Assessment of lower urinary tract symptoms (LUTS) for both prostate cancer and BPH patients. The IPSS/AUASS consists of 7 questions regarding urinary symptoms. Total scores range from 0 to 35. A score of 0-7 indicates mild symptoms, 8-19 moderate symptoms, and 20-35 severe symptoms. Higher scores indicate worse urinary outcomes.
Measured: Baseline, 3, 6, 12 months, and annually up to 10 years
Change in Erectile Function (SHIM / IIEF-5 Score)
Erectile function and ability to maintain an erection satisfactory for penetration assessed via the Sexual Health Inventory for Men (SHIM), also known as the IIEF-5. Total scores range from 1 to 25. A score of 22-25 indicates normal erectile function, while scores of 21 or below indicate varying degrees of erectile dysfunction. Lower scores indicate worse sexual function outcomes.
Measured: Baseline, 3, 6, 12 months, and annually up to 10 years
Pad-Free Urinary Continence Rate
Proportion of patients achieving complete pad-free urinary continence following HIFU treatment, clinically defined as the use of zero absorbent pads per day for urinary leakage.
Measured: 3, 6, 12 months, and annually up to 10 years
Intraoperative Tissue Change Monitoring (TCM) Correlation
Correlation of intraoperative Tissue Change Monitoring (TCM) data with post-operative IPSS relief and PSA nadir to identify predictors of treatment success.
Measured: Up to 10 years
Salvage-Free Survival
Time from the primary Sonablate HIFU procedure (index date) to the initiation of any post-ablation salvage treatment (e.g., radical prostatectomy, radiation therapy, systemic therapy, or repeat HIFU ablation), evaluated via time-to-event longitudinal survival analysis.
Measured: Up to 10 years
Number of Participants with Procedure-Related Adverse Events
Number of participants experiencing urological, functional, or rectal complications post-HIFU, extracted from de-identified medical records following a mandatory 180-day abstraction delay. Severity is graded via the Clavien-Dindo system (Grade I [minor] to Grade V [death]), where higher grades indicate greater severity.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Jan 2015
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Localized Prostate CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Sonablate
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Responsible party
- Sponsor
- Investigators
- Clint D. Bahler, MD, MS, Principal investigator, Indiana University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757490
- Sponsor's protocol ID
- SHIR012026
- Other IDs
- SHIR012026
- Acronym
- SONAFUSION
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) will not be shared externally. To strictly adhere to national and international data sovereignty laws, the registry operates under an independent Honest Broker framework. All centralized data is fully de-identified according to HIPAA Safe Harbor standards prior to transmission. Access to the aggregated database is strictly governed by legally binding Data Transfer Agreements (DTAs) and restricted exclusively to eligible participating clinical sites. Public or external sharing of individual-level data is explicitly prohibited to guarantee absolute patient privacy
Publications
Light A, Peters M, Gopalakrishnan A, Mayor N, Cullen E, Boaz RJ, Norris JM, Morris S, Arya M, Tanaka MB, Doherty A, Dudderidge T, Emara A, Emberton M, Grey A, Hindley R, Laniado M, McCraken S, Moore CM, Nigam R, Noureldin M, Orczyk C, Rakauskas A, Simmons L, Virdi J, Withington J, Zakikhani P, Ahmed HU, Shah TT. Oncological Outcomes Following Focal HIFU and Cryotherapy for Treatment of Nonmetastatic Prostate Cancer in the United Kingdom: An Updated Analysis of 3477 Patients from the Prospective HEAT and ICE Registries. Eur Urol. 2026 Jul 10:S0302-2838(26)02169-X. doi: 10.1016/j.eururo.2026.05.007. Online ahead of print.
PubMed 42431756Garcia-Gutierrez CM, Garcia-Becerra CA, Garcia-Becerra N, Becerra-Herrejon H, Shoji S, Sanghvi NT. Histoblast: A Novel Cavitative High-Intensity Focused Ultrasound (HIFU)-Modified Technique for Benign Prostatic Hyperplasia. Cureus. 2025 Dec 11;17(12):e98989. doi: 10.7759/cureus.98989. eCollection 2025 Dec.
PubMed 41523515Khandwala YS, Soerensen SJC, Morisetty S, Ghanouni P, Fan RE, Vesal S, Rusu M, Sonn GA. The Association of Tissue Change and Treatment Success During High-intensity Focused Ultrasound Focal Therapy for Prostate Cancer. Eur Urol Focus. 2023 Jul;9(4):584-591. doi: 10.1016/j.euf.2022.10.010. Epub 2022 Nov 10.
PubMed 36372735Guillaumier S, Peters M, Arya M, Afzal N, Charman S, Dudderidge T, Hosking-Jervis F, Hindley RG, Lewi H, McCartan N, Moore CM, Nigam R, Ogden C, Persad R, Shah K, van der Meulen J, Virdi J, Winkler M, Emberton M, Ahmed HU. A Multicentre Study of 5-year Outcomes Following Focal Therapy in Treating Clinically Significant Nonmetastatic Prostate Cancer. Eur Urol. 2018 Oct;74(4):422-429. doi: 10.1016/j.eururo.2018.06.006. Epub 2018 Jun 28.
PubMed 29960750Koch MO, Gardner T, Cheng L, Fedewa RJ, Seip R, Sanghvi NT. Phase I/II trial of high intensity focused ultrasound for the treatment of previously untreated localized prostate cancer. J Urol. 2007 Dec;178(6):2366-70; discussion 2370-1. doi: 10.1016/j.juro.2007.08.014. Epub 2007 Oct 22.
PubMed 17936800Shoji S, Naruse J, Ohno S, Aoki M, Takahashi K, Yuzuriha S, Kuroda S, Umemoto T, Nakajima N, Hasegawa M, Kawamura Y, Kajiwara H, Hashida K, Uemura K, Hasebe T, Tajiri T. Focal therapy using high-intensity focused ultrasound with intraoperative prostate compression for patients with localized prostate cancer: a multi-center prospective study with 7 year experience. Prostate Cancer Prostatic Dis. 2025 Sep;28(3):782-788. doi: 10.1038/s41391-024-00921-0. Epub 2024 Nov 23.
PubMed 39580599
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SONAFUSION Registry (Long-term Evaluation of Sonablate High-Intensity Focused Ultrasound for the Treatment of Prostate Cancer and Benign Prostatic Hyperplasia)
- ClinicalTrials.gov ID
- NCT07757490
- Acronym / sponsor ID
- SONAFUSION / SHIR012026
- Conditions
- Localized Prostate Cancer, BPH (Benign Prostatic Hyperplasia), Prostate Cancer; Benign Prostatic Hyperplasia
- Keywords
- HIFU, LOFU, High Intensity Focused Ultrasound, Sonablate, Directional Compression, Bolus Guide, prostate cancer, BPH, Histoblast, Sonatripsy, High-Intensity Focused Ultrasound, HIFU, Sonablate, Lower Urinary Tract Symptoms, Minimally Invasive, Prostate Ablation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- SonablateIndustry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 11 Aug 2026 (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.
The SONA FUSION Registry is an observational study designed to evaluate the long-term effectiveness and safety of the Sonablate High-Intensity Focused Ultrasound (HIFU) system. This study focuses on adult men who have been treated for localized prostate cancer, benign prostatic hyperplasia (BPH) with urinary symptoms, or a combination of both conditions. The registry collects real-world medical data from multiple clinics globally to better understand how well the HIFU treatment controls disease and affects urinary and sexual function over a 10- to 20-year period.
The study includes two groups of participants: a retrospective group of patients who previously received treatment, and a prospective group of newly treated patients receiving standard clinical care. No experimental interventions are assigned for the purpose of this study. To protect participant privacy, all medical data is completely de-identified and stripped of direct identifiers before being securely transferred to the central coordinating center at Indiana University. The ultimate goal of this research is to improve patient care protocols, advance men's health knowledge, and establish evidence-based guidelines for minimally invasive prostate treatments.
Detailed description
Traditional surgical interventions for prostate cancer and benign prostatic hyperplasia (BPH) are often associated with significant morbidity. While high-intensity focused ultrasound (HIFU) has emerged as a recognized, minimally invasive alternative, existing clinical evidence often lacks prospective, long-term follow-up and standardized, validated outcome assessments.
To systematically track and evaluate these standard-of-care interventions, the SONA FUSION Registry serves as a central repository for the consolidation of real-world clinical data from leading academic and clinical centers globally. The registry is designed to refine HIFU treatment protocols, improve patient counseling practices, and establish evidence-based scientific foundations for the standardized adoption of robotic HIFU technology.
The central repository at Indiana University receives and maintains exclusively de-identified research data. The protocol structurally prevents re-identification by mandating the permanent removal of all direct identifiers at the local site level prior to transmission. Furthermore, clinical dates are strictly protected via temporal masking, converting all temporal data to relative study days-and a non-negotiable 180-day post-procedure delay is enforced before any prospective data is authorized for abstraction.
To continuously validate these safeguards, an independent Honest Broker conducts an annual audit of a 20 percent sample of the database, ensuring the central research team remains definitively blinded to all patient identifiers.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | Device: High Intensity Focused UltrasoundHistorical, fully de-identified clinical data from patients treated for localized prostate cancer or BPH who underwent Sonablate HIFU ablation as part of standard clinical care. |
| Prospective Cohort | – | –Newly treated prostate cancer or BPH patients undergoing Sonablate HIFU ablation as part of standard clinical care, subject to a mandatory 180-day post-procedure data abstraction delay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult biological males (≥18 years) diagnosed with localized prostate cancer and/or benign prostatic hyperplasia (BPH) with lower urinary tract symptoms (LUTS), who have undergone Sonablate HIFU ablation strictly as part of routine standard clinical care
Key inclusion criteria (2 listed)
- Male with diagnosed localized prostate cancer or BPH (benign prostatic hyperplasia)
- Having undergone Sonablate HIFU ablation as part of standard clinical care, with all central data transmission subject to a mandatory 180-day post-procedure delay.
Key exclusion criteria (5 listed)
- Prostate size or lesion location precluding effective HIFU target acquisition (prostate volume >100 CC for prostate cancer or >80 CC for BPH)
- Confirmed metastatic prostate cancer
- Prior radical prostatectomy
- Prostates with large calcifications (>10mm causing shadowing)
- Prior rectal wall surgery or inability to undergo transrectal ultrasound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Focused UltrasoundUse of high intensity focused utrasound and sonatripsy for thermal and mechanical tissue ablation | Device | Retrospective Cohort |
Primary outcome
Biochemical and Histological Recurrence-Free Survival Rate
Time frame: Baseline, and annually up to 10 years
Proportion of patients remaining free of clinically significant prostate cancer recurrence in the treated area, evaluated via standard-of-care Prostate Specific Antigen (PSA) testing, multiparametric MRI, and/or follow-up prostate biopsy.
6 secondary outcomes
Change in International Prostate Symptom Score (IPSS) / AUA Symptom Score
Time frame: Baseline, 3, 6, 12 months, and annually up to 10 years
Change in Erectile Function (SHIM / IIEF-5 Score)
Time frame: Baseline, 3, 6, 12 months, and annually up to 10 years
Pad-Free Urinary Continence Rate
Time frame: 3, 6, 12 months, and annually up to 10 years
Intraoperative Tissue Change Monitoring (TCM) Correlation
Time frame: Up to 10 years
Salvage-Free Survival
Time frame: Up to 10 years
Number of Participants with Procedure-Related Adverse Events
Time frame: Up to 10 years
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 13 Aug 2026.
- Background: PubMed 42431756Light A, Peters M, Gopalakrishnan A, Mayor N, Cullen E, Boaz RJ, Norris JM, Morris S, Arya M, Tanaka MB, Doherty A, Dudderidge T, Emara A, Emberton M, Grey A, Hindley R, Laniado M, McCraken S, Moore CM, Nigam R, Noureldin M, Orczyk C, Rakauskas A, Simmons L, Virdi J, Withington J, Zakikhani P, Ahmed HU, Shah TT. Oncological Outcomes Following Focal HIFU and Cryotherapy for Treatment of Nonmetastatic Prostate Cancer in the United Kingdom: An Updated Analysis of 3477 Patients from the Prospective HEAT and ICE Registries. Eur Urol. 2026 Jul 10:S0302-2838(26)02169-X. doi: 10.1016/j.eururo.2026.05.007. Online ahead of print.
- Background: PubMed 41523515Garcia-Gutierrez CM, Garcia-Becerra CA, Garcia-Becerra N, Becerra-Herrejon H, Shoji S, Sanghvi NT. Histoblast: A Novel Cavitative High-Intensity Focused Ultrasound (HIFU)-Modified Technique for Benign Prostatic Hyperplasia. Cureus. 2025 Dec 11;17(12):e98989. doi: 10.7759/cureus.98989. eCollection 2025 Dec.
- Background: PubMed 36372735Khandwala YS, Soerensen SJC, Morisetty S, Ghanouni P, Fan RE, Vesal S, Rusu M, Sonn GA. The Association of Tissue Change and Treatment Success During High-intensity Focused Ultrasound Focal Therapy for Prostate Cancer. Eur Urol Focus. 2023 Jul;9(4):584-591. doi: 10.1016/j.euf.2022.10.010. Epub 2022 Nov 10.
- Background: PubMed 29960750Guillaumier S, Peters M, Arya M, Afzal N, Charman S, Dudderidge T, Hosking-Jervis F, Hindley RG, Lewi H, McCartan N, Moore CM, Nigam R, Ogden C, Persad R, Shah K, van der Meulen J, Virdi J, Winkler M, Emberton M, Ahmed HU. A Multicentre Study of 5-year Outcomes Following Focal Therapy in Treating Clinically Significant Nonmetastatic Prostate Cancer. Eur Urol. 2018 Oct;74(4):422-429. doi: 10.1016/j.eururo.2018.06.006. Epub 2018 Jun 28.
- Background: PubMed 17936800Koch MO, Gardner T, Cheng L, Fedewa RJ, Seip R, Sanghvi NT. Phase I/II trial of high intensity focused ultrasound for the treatment of previously untreated localized prostate cancer. J Urol. 2007 Dec;178(6):2366-70; discussion 2370-1. doi: 10.1016/j.juro.2007.08.014. Epub 2007 Oct 22.
- Background: PubMed 39580599Shoji S, Naruse J, Ohno S, Aoki M, Takahashi K, Yuzuriha S, Kuroda S, Umemoto T, Nakajima N, Hasegawa M, Kawamura Y, Kajiwara H, Hashida K, Uemura K, Hasebe T, Tajiri T. Focal therapy using high-intensity focused ultrasound with intraoperative prostate compression for patients with localized prostate cancer: a multi-center prospective study with 7 year experience. Prostate Cancer Prostatic Dis. 2025 Sep;28(3):782-788. doi: 10.1038/s41391-024-00921-0. Epub 2024 Nov 23.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared externally. To strictly adhere to national and international data sovereignty laws, the registry operates under an independent Honest Broker framework. All centralized data is fully de-identified according to HIPAA Safe Harbor standards prior to transmission. Access to the aggregated database is strictly governed by legally binding Data Transfer Agreements (DTAs) and restricted exclusively to eligible participating clinical sites. Public or external sharing of individual-level data is explicitly prohibited to guarantee absolute patient privacy
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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.
Clint D. Bahler, MD, MS principal investigator
Indiana University 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 Localized Prostate Cancer and BPH (Benign Prostatic Hyperplasia), run by Sonablate 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 2 inclusion and 5 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 13 Aug 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 Clint D. Bahler, MD, MS (317-944-3458, cdbahler@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical and Histological Recurrence-Free Survival Rate (time frame: Baseline, and annually up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07757490, which also lists 6 linked publications.
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 13 Aug 2026.