Ablative Therapy in the Management of Prostate Cancer

NCT03492424 | Recruiting DMC FDA Device

• 1 other identifier: 1702017952 prev. 1702018011
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is collect observational data regarding patterns of care and outcomes of focal therapies for prostate cancer, including but not limited to: high-intensity focused ultrasound (HIFU), cryotherapy, focal laser ablation, irreversible electroporation, photodynamic therapy, and brachytherapy.

Conditions

Prostate Cancer

Keywords

prostate cancer; cryotherapy; focal therapy

Outcome Measures

Primary Outcomes (1)

• Prostate biopsy Gleason grade

  Will be obtained through patient biopsy pathology results

  12 months

Secondary Outcomes (7)

• Patient characteristics/demographics

  12 months

• MRI PI-RAD grade

  12 months

• Lab results - PSA level

  12 months

• Patient-reported quality of life: EPIC-26

  12 months

• Patient-reported quality of life: IIEF-5

  12 months

Study Arms (1)

Focal therapy for prostate cancer

All men \>18 years of age undergoing focal therapy for primary or salvage treatment of prostate cancer will be included. Men who had received prior focal therapy are also eligible for inclusion. The purpose of this study is collect observational data regarding patterns of care and outcomes of focal therapies for prostate cancer, including but not limited to: high-intensity focused ultrasound (HIFU), cryotherapy, focal laser ablation, irreversible electroporation, photodynamic therapy, and brachytherapy.

Device: cryotherapy

Interventions

cryotherapy DEVICE

Subjects will receive focal cryotherapy for treatment of prostate cancer

Focal therapy for prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are generally healthy men diagnosed with prostate cancer, undergoing focal therapy for treatment of prostate cancer.

You may qualify if:

• \>18 years of age
• Undergoing focal therapy for primary or salvage treatment of prostate cancer, or
• Have received prior focal therapy

You may not qualify if:

• Clinically-evident metastatic disease
• Unable to fill out an English-language questionnaire

Sponsors & Collaborators

• Prostate Cancer Foundation: collaborator
• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Tim McClure, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Holly Kuczynsk, BS

CONTACT

646-962-7523; hok4001@med.cornell.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: April 10, 2018
• Study Start: January 2, 2018
• Primary Completion (Estimated): March 2, 2032
• Study Completion (Estimated): September 2, 2039
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)