NCT07203482 Clinical Outcomes in Prostate Cancer Patients Undergoing HIFU Ablation
| NCT ID | NCT07203482 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-05-16 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-05-16 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
James Wysock, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT07203482 clinical trial?
This trial is open to male participants only, aged 40 Years or older, up to 95 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07203482 currently recruiting?
Yes, NCT07203482 is actively recruiting participants. Contact the research team at Majlinda.Tafa@nyulangone.org for enrollment information.
Where is the NCT07203482 trial being conducted?
This trial is being conducted at Brooklyn, United States, New York, United States.
Who is sponsoring the NCT07203482 clinical trial?
NCT07203482 is sponsored by NYU Langone Health. The principal investigator is James Wysock, MD at NYU Langone Health. The trial plans to enroll 300 participants.
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