Neoplasms

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Prostatic Neoplasms

Genital Neoplasms, Male

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Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Unilateral Nerve-Sparing Cryoablation of the Prostate using Galil Medical Precise Cryoablation System with IceRod Needles.

The side of the prostate affected by cancer will be treated with nerve-sparing cryoablation in two freeze-thaw cycles under transrectal ultrasound guidance. The unaffected side of the prostate will not be treated.

Unilateral Nerve-Sparing Cryoablation of the Prostate

Galil Medical Precise Cryoablation System with IceRod Needles will be used for performing Unilateral Nerve-Sparing Cryoablation

Precise Cryoablation System with IceRod Needles

Aaron E Katz, MD

Men with low-risk, clinically localized, unilateral prostate cancer will be treated with unilateral nerve-sparing cryoablation and evaluated for the rate of potency, cancer control and health related quality of life outcomes after treatment.

This study is a clinical trial to determine and assess the change in the rate of potency in men with low-risk, localized, unilateral prostate cancer who have not received previous treatment. A total of 86 men between 40 to 69 years of age with biopsy proven, early stage localized prostate cancer will receive unilateral nerve-sparing cryoablation. The study includes a screening/pre-operative visit, a cryoablation procedure day, and 10 follow up visits over the course of 36 months. The first follow-up visit will occur within 2 weeks (±1 week) after cryoablation. Thereafter, follow-up visits will be scheduled, from the date of procedure, every 3 months (±3 weeks) for 18 months and every 6 months (±3 weeks) thereafter until the patient completes the protocol, 36 months after the cryoablation procedure.

Unilateral Nerve-Sparing Cryoablation for Low-Risk, Clinically Localized, Unilateral Prostate Cancer

Unilateral Nerve-Sparing Cryoablation for Low-Risk, Clinically Localized, Unilateral Prostate Cancer in Potent Men: A Prospective, Phase II Trial

Determine and assess the change in the rate of potency in men with unilateral prostate cancer treated with unilateral nerve-sparing cryoablation as measured by Expended Prostate Cancer Index Composite (EPIC) and International Index of Erectile Function (IIEF-15) questionnaires

Evaluate cancer control in the prostate side treated with unilateral nerve-sparing cryoablation by assessing the rate of tumor development

Assess the rate of tumor development in the contralateral (untreated) side of the prostate

Analyze the change in overall Health Related Quality of Life as measured by Expanded Prostate Cancer Index Composite (EPIC)

Analyze the change in overall Health Related Quality of Life as measured by the Short Form-12 (SF-12) Questionnaire

Evaluate the change in Urinary Continence status compared to baseline as measured by the Urinary domain of the Expanded Prostate Cancer Index Composite (EPIC) questionnaire

Evaluate the change in voiding function compared to baseline as measured by International Prostate Symptom Score (IPSS)

Evaluate the change in voiding function compared to baseline as measured by Uroflowmetry

Evaluate the change in voiding function compared to baseline as measured by Post-Void Residual (PVR)

Evaluate the change in bowel function compared to baseline as measured by the Bowel domain of the Expanded Prostate Cancer Index Composite (EPIC) questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Unilateral Nerve-Sparing Cryoablation for Low-Risk, Clinically Localized, Unilateral Prostate Cancer	NCT02459912	Prostate Cancer	Unilateral Nerv... Precise Cryoabl...	40 Years - 69 Years	NYU Langone Health
Unilateral Nerve-Sparing Cryoablation for Low-Risk, Clinically Localized, Unilateral Prostate Cancer	NCT02459912	Prostate Cancer	Unilateral Nerv... Precise Cryoabl...	40 Years - 69 Years	NYU Langone Health
Unilateral Nerve-Sparing Cryoablation for Low-Risk, Clinically Localized, Unilateral Prostate Cancer	NCT02459912	Prostate Cancer	Unilateral Nerv... Precise Cryoabl...	40 Years - 69 Years	NYU Langone Health

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