Outcomes after focal cryotherapy for localized prostate cancer
Prospective Database of Clinical Outcomes Following Cryotherapy for Ablation of Clinically Localized Prostate Cancer
This project collects information from men with localized prostate cancer who choose focal cryotherapy to see how well the treatment controls disease and what side effects occur.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | Male |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07184957 on ClinicalTrials.gov |
What this trial studies
This prospective database will record baseline clinical, imaging, and biopsy information and then track treatment outcomes for men undergoing focal cryoablation of clinically localized prostate cancer at NYU Langone. Men whose cancer appears confined to the prostate by MRI and biopsy who elect focal cryotherapy are invited to enroll. Investigators will collect standardized follow‑up data on PSA, imaging, biopsy results when performed, and complications without changing patients' chosen treatments. The compiled data will be used to describe real-world oncologic and functional outcomes and to inform patient counseling and selection.
Who should consider this trial
Good fit: Men with clinically localized prostate cancer confined to the prostate on MRI and biopsy who choose focal cryoablation are the intended participants.
Not a fit: Men without prostate cancer, those with evidence of metastatic disease, or those who choose other treatments will not be included and are unlikely to benefit from this database.
Why it matters
Potential benefit: If successful, the database could help doctors and patients understand real-world cancer control rates and side-effect risks after focal cryotherapy.
How similar studies have performed: Small series and registries have reported acceptable local control with cryotherapy in selected patients, but high-quality comparative data for focal cryoablation remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) will be counseled regarding treatment options. Those selecting focal Cryo prostate ablation will then be offered inclusion into this data collection. Exclusion Criteria: * Men that are not diagnosed with prostate cancer. * Men that are diagnosed with clinically localized prostate cancer, but select other treatment options as their desired treatment.
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: James Wysock, MD — NYU Langone Health
- Study coordinator: Majlinda Tafa
- Email: Majlinda.Tafa@nyulangone.org
- Phone: (646) 825-6338
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.