Prospective Database of Clinical Outcomes Following Cryot... | NCT07184957

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

NCT07184957

Sponsor

NYU Langone Health

Status

Recruiting

Last Update Posted

Sep 22, 2025Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2017Actual

Primary Completion Date

Dec 31, 2030Estimated

Completion Date

Dec 31, 2040Estimated

First Submitted Date

Sep 15, 2025

First Submission Date that Met QC Criteria

Sep 15, 2025

First Posted Date

Sep 22, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2025

Last Update Posted Date

Sep 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Men with Prostate Cancer		Men who receive cryotherapy for ablation of clinically localized prostate cancer.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Majlinda Tafa	Contact	(646) 825-6338		Majlinda.Tafa@nyulangone.org
James Wysock, MD	Contact	(646) 825-6366		James.Wysock@nyulangone.org

Overall Officials

Name	Affiliation	Role
James Wysock, MD	NYU Langone Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NYU Langone Health	Recruiting	New York	New York	10016	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Study Protocol
Statistical Analysis Plan (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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided