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Ablative Therapy in the Management of Prostate Cancer

NCT ID: NCT03492424

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-02

Study Completion Date

2039-09-02

Brief Summary

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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.

Detailed Description

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Through the use of a pro- and retrospective registry, the investigators will collect information on patient characteristics including age, co-morbidities, imaging and biopsy information, and prior treatments. Information on treatment details will also be captured, including treatment time, anesthesia delivered, and length of stay, when applicable. Oncologic outcomes including PSA, post-treatment biopsy and imaging data, need for re-treatment, and survival outcomes will also be captured. Safety outcomes will be captured using the Clavien-Dindo classification scale, and additional specific GU complications will be recorded, which include urinary retention, urethral stricture, recto-urethral fistula, osteomyelitis, and urinary tract infection. Finally, the investigators will capture functional outcomes using health related quality of life questionnaires including the EPIC questionnaire, IIEF-5, MSHQ-EjD, and IPSS.

Conditions

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Prostate Cancer

Keywords

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prostate cancer cryotherapy focal therapy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

cryotherapy

Intervention Type DEVICE

Subjects will receive focal cryotherapy for treatment of prostate cancer

Interventions

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cryotherapy

Subjects will receive focal cryotherapy for treatment of prostate cancer

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Clinically-evident metastatic disease
* Unable to fill out an English-language questionnaire
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Prostate Cancer Foundation

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tim McClure, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medicine

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Holly Kuczynsk, BS

Role: CONTACT

Phone: 646-962-7523

Email: [email protected]

Facility Contacts

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Holly Kuczynski

Role: primary

Other Identifiers

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1702017952 prev. 1702018011

Identifier Type: -

Identifier Source: org_study_id