Prospective Database of Clinical Outcomes Following Cryotherapy for Ablation of Clinically Localized Prostate Cancer
1 other identifier
observational
1,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 15, 2025
CompletedFirst Posted
Study publicly available on registry
September 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2040
September 22, 2025
September 1, 2025
13.7 years
September 15, 2025
September 15, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Treatment Complications
Up to Year 15
PSA-Progression Free Survival
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
Study Arms (1)
Men with Prostate Cancer
Men who receive cryotherapy for ablation of clinically localized prostate cancer.
Eligibility Criteria
Men who receive cryotherapy for ablation of clinically localized prostate cancer.
You may qualify if:
- Evidence of focal prostate cancer confined to the prostate based on MRI imaging and prostate biopsy
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Wysock, MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2025
First Posted
September 22, 2025
Study Start
May 1, 2017
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2040
Last Updated
September 22, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.