Prostate Cancer
Conditions
Brief 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. 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.
Interventions
None listed
Sponsors
NYU Langone Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
40 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | — |
Countries
United States
Contacts
CONTACTMajlinda Tafa, MD
CONTACTJames Wysock, MD
PRINCIPAL_INVESTIGATORJames Wysock, MD
NYU Langone Health
Outcome results
None listed