Prostate CancerNCT07203482
Clinical Outcomes in Prostate Cancer Patients Undergoing HIFU Ablation
An observational study of Prostate Cancer, run by NYU Langone Health at 2 sites in United States.
Trial summary
Many reports of clinical outcomes following treatment of localized prostate cancer suffer from lack of prospective long-term data using objective and validated outcome instruments. Read more about this study
- Who is it for?
- Ages 40 to 95 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 May 2024to 31 Dec 2050
- 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 40 to 95 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Males, age 40-95 who are prostate cancer patients.
Who may be able to join
- Males, ages 40-95
- Evidence of focal prostate cancer confined to the prostate based on MRI imaging and prostate biopsy
- Patients with clinically localized prostate cancer (no evidence for or concern for metastatic spread of cancer outside of the prostate) that select focal HIFU prostate ablation as their treatment option will be offered inclusion into this prospective data collection research database.
- Patients who have early (Gleason 6 or 7), low grade cancer that is confined to the prostate.
- Willing and able to provide consent.
Who cannot join
- Patients that are not diagnosed with prostate cancer.
- Patients that are diagnosed with clinically localized prostate cancer, but select other tratment options as their desired treatment.
- Patients that are not willing or are not able to give consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
NYU Langone Health - Cobble Hill
Brooklyn, New York, 11201
- Recruiting
NYU Langone Health - Tisch Hospital
New York, New York, 10016
About this study
Official title: A Single-center Observational Study of Clinical Outcomes of Clinically Localized Prostate Cancer Undergoing HIFU Therapy
Many reports of clinical outcomes following treatment of localized prostate cancer suffer from lack of prospective long-term data using objective and validated outcome instruments. The purpose of this research database is to prospectively collect data to assess treatment related complications, oncologic outcomes and urinary/sexual function, and identify predictors of complications, oncological control and functional outcomes after Hhigh-intensity focused ultrasound (HIFU) ablation of prostate cancer with the intent to guide further research and improve patient care. We will include subjects who will have a HIFU procedure performed from all Sub-Investigators included in the study.
- Conditions
- Prostate Cancer
- 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 |
|---|---|---|
| Prostate Cancer Patients Scheduled for HIFU Procedure | Participants will be actively followed up for the first 3 years. After that once a year for life, unless they withdraw from the study or no longer seek standard of care at NYU Langone Health. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Prostate-Specific Antigen (PSA) Levels
Measured: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Change in Urinary Function Score
Urinary Function is assessed using an 8-item questionnaire; each item is rated on a question-specific Likert scale. The total score is the sum of responses and ranges from 0 - 41; lower scores indicate greater urinary function.
Measured: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Change in Urinary Continence Score
Urinary Continence is assessed using an 2-item questionnaire; each item is rated on a Likert scale from 0-3. The total score is the sum of responses and ranges from 0 - 6; higher scores indicate greater urinary continence.
Measured: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Change in Sexual Function Score
Sexual Function is assessed using a 6-item questionnaire; each item is rated on a question-specific Likert scale. The total score is the sum of responses and ranges from 0 - 29; lower scores indicate greater sexual function.
Measured: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Change in Ejaculatory Function Score
Ejaculatory Function is assessed using a 4-item questionnaire; each item is rated on a question-specific Likert scale. The total score is the sum of responses and ranges from 1 - 20; higher scores indicate greater ejaculatory function.
Measured: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Change in Sexual Health Inventory for Men (SHIM) Score
SHIM is a 5-item questionnaire assessing sexual health in men; each item is rated on a question-specific Likert scale. The total score is the sum of responses and ranges from 1-20; higher scores indicate greater sexual health.
Measured: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Decision Regret Score
Regret toward receiving HIFU ablation focal therapy is assessed using a 5-item questionnaire. Each item is rated on a Likert scale from 1-5; the total score is the sum of responses and ranges from 5-25. Lower scores indicate less regret with the decision.
Measured: Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Number of Participants with Persistence or Recurrence of Cancer within the Treatment Zone on Post-Treatment Imaging
Measured: Up to Month 60
Number of Participants with New Lesions in the Non-Treated Prostate on Post-Treatment Imaging
Measured: Up to Month 60
Number of Participants with Persistence or Recurrence of Cancer within the Treatment Zone on Post-Treatment Prostate Biopsy
Measured: Up to Month 60
Number of Participants with New Lesions in the Non-Treated Prostate on Post-Treatment Prostate Biopsy
Measured: Up to Month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start16 May 2024
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2050 (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 NYU Langone HealthThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Wysock, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203482
- Sponsor's protocol ID
- 23-01458
- Status last verified
- Jul 2026
- First submitted
- 23 Sep 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: James.Wysock@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Observational Study of Clinical Outcomes of Clinically Localized Prostate Cancer Undergoing HIFU Therapy
- ClinicalTrials.gov ID
- NCT07203482
- Acronym / sponsor ID
- 23-01458
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 16 May 2024 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 2 Oct 2025 (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.
Many reports of clinical outcomes following treatment of localized prostate cancer suffer from lack of prospective long-term data using objective and validated outcome instruments. The purpose of this research database is to prospectively collect data to assess treatment related complications, oncologic outcomes and urinary/sexual function, and identify predictors of complications, oncological control and functional outcomes after Hhigh-intensity focused ultrasound (HIFU) ablation of prostate cancer with the intent to guide further research and improve patient care. We will include subjects who will have a HIFU procedure performed from all Sub-Investigators included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer Patients Scheduled for HIFU Procedure | – | –Participants will be actively followed up for the first 3 years. After that once a year for life, unless they withdraw from the study or no longer seek standard of care at NYU Langone Health. |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males, age 40-95 who are prostate cancer patients.
Key inclusion criteria (5 listed)
- Males, ages 40-95
- Evidence of focal prostate cancer confined to the prostate based on MRI imaging and prostate biopsy
- Patients with clinically localized prostate cancer (no evidence for or concern for metastatic spread of cancer outside of the prostate) that select focal HIFU prostate ablation as their treatment option will be offered inclusion into this prospective data collection research database.
- Patients who have early (Gleason 6 or 7), low grade cancer that is confined to the prostate.
- Willing and able to provide consent.
Key exclusion criteria (3 listed)
- Patients that are not diagnosed with prostate cancer.
- Patients that are diagnosed with clinically localized prostate cancer, but select other tratment options as their desired treatment.
- Patients that are not willing or are not able to give consent.
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
Change in Prostate-Specific Antigen (PSA) Levels
Time frame: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Change in Urinary Function Score
Time frame: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Urinary Function is assessed using an 8-item questionnaire; each item is rated on a question-specific Likert scale. The total score is the sum of responses and ranges from 0 - 41; lower scores indicate greater urinary function.
Change in Urinary Continence Score
Time frame: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Urinary Continence is assessed using an 2-item questionnaire; each item is rated on a Likert scale from 0-3. The total score is the sum of responses and ranges from 0 - 6; higher scores indicate greater urinary continence.
Change in Sexual Function Score
Time frame: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Sexual Function is assessed using a 6-item questionnaire; each item is rated on a question-specific Likert scale. The total score is the sum of responses and ranges from 0 - 29; lower scores indicate greater sexual function.
Change in Ejaculatory Function Score
Time frame: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Ejaculatory Function is assessed using a 4-item questionnaire; each item is rated on a question-specific Likert scale. The total score is the sum of responses and ranges from 1 - 20; higher scores indicate greater ejaculatory function.
Change in Sexual Health Inventory for Men (SHIM) Score
Time frame: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
SHIM is a 5-item questionnaire assessing sexual health in men; each item is rated on a question-specific Likert scale. The total score is the sum of responses and ranges from 1-20; higher scores indicate greater sexual health.
Decision Regret Score
Time frame: Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Regret toward receiving HIFU ablation focal therapy is assessed using a 5-item questionnaire. Each item is rated on a Likert scale from 1-5; the total score is the sum of responses and ranges from 5-25. Lower scores indicate less regret with the decision.
Number of Participants with Persistence or Recurrence of Cancer within the Treatment Zone on Post-Treatment Imaging
Time frame: Up to Month 60
Number of Participants with New Lesions in the Non-Treated Prostate on Post-Treatment Imaging
Time frame: Up to Month 60
Number of Participants with Persistence or Recurrence of Cancer within the Treatment Zone on Post-Treatment Prostate Biopsy
Time frame: Up to Month 60
Number of Participants with New Lesions in the Non-Treated Prostate on Post-Treatment Prostate Biopsy
Time frame: Up to Month 60
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 30 Jul 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: James.Wysock@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
James Wysock, MD principal investigator
NYU Langone Health
2 sites 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 NYU Langone Health at 2 sites 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 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Majlinda Tafa, MD ((646) 825-6338, Majlinda.Tafa@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Prostate-Specific Antigen (PSA) Levels (time frame: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60). The study lists 11 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 30 Jul 2026.