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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Prostate-Specific Antigen (PSA) Levels | 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. | 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. | 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. | 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. | Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60 |
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Inclusion Criteria:
Exclusion Criteria:
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Males, age 40-95 who are prostate cancer patients.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Majlinda Tafa, MD | Contact | (646) 825-6338 | Majlinda.Tafa@nyulangone.org | |
| James Wysock, MD | Contact | (646) 825-6366 | James.Wysock@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| James Wysock, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health - Cobble Hill | Recruiting | Brooklyn | New York | 11201 | United States | |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to James.Wysock@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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. | 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. | 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 | Up to Month 60 |
| Number of Participants with New Lesions in the Non-Treated Prostate on Post-Treatment Imaging | Up to Month 60 |
| Number of Participants with Persistence or Recurrence of Cancer within the Treatment Zone on Post-Treatment Prostate Biopsy | Up to Month 60 |
| Number of Participants with New Lesions in the Non-Treated Prostate on Post-Treatment Prostate Biopsy | Up to Month 60 |
| NYU Langone Health - Tisch Hospital |
| Recruiting |
| New York |
| New York |
| 10016 |
| United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |