Prospective Database of Clinical Outcomes Following Cryotherapy for Ablation of Clinically Localized Prostate Cancer

September 15, 2025 updated by: NYU Langone Health
This will be a prospectively maintained research database. The purpose is to record baseline parameters and treatment outcomes following of Cryotherapy for ablation of clinically localized prostate cancer.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Men who receive cryotherapy for ablation of clinically localized prostate cancer.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Men with Prostate Cancer
Men who receive cryotherapy for ablation of clinically localized prostate cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Complications
Time Frame: Up to Year 15
Up to Year 15
PSA-Progression Free Survival
Time Frame: Up to Year 15
Length of time following cryotherapy for ablation treatment of prostate cancer that a patient lives without their prostate-specific antigen (PSA) levels rising significantly enough to indicate disease recurrence, or without dying from any cause.
Up to Year 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: James Wysock, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2040

Study Registration Dates

First Submitted

September 15, 2025

First Submitted That Met QC Criteria

September 15, 2025

First Posted (Actual)

September 22, 2025

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-00354

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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