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

NCT02459912 | Terminated Phase 2 DMC

• 1 other identifier: 15009
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate; Minimally; Low-Risk; Invasive; Cancer

Outcome Measures

Primary Outcomes (1)

• Potency Rate

  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

  3 years

Secondary Outcomes (9)

• Cancer Control in Treated Side

  3 years

• Cancer Control in Untreated Side

  3 years

• Overall Health Related Quality of Life (EPIC)

  3 years

• Overall Health Related Quality of Life (SF-12)

  3 years

• Change in Urinary Continence

  3 years

Study Arms (1)

Unilateral Nerve-Sparing Cryoablation

OTHER

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

Procedure: Unilateral Nerve-Sparing Cryoablation of the Prostate; Device: Precise Cryoablation System with IceRod Needles

Interventions

Unilateral Nerve-Sparing Cryoablation of the Prostate PROCEDURE

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

Precise Cryoablation System with IceRod Needles DEVICE

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

Unilateral Nerve-Sparing Cryoablation

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Life expectancy \>5 years
• Willing and able to freely sign informed consent to enroll in the study
• Willing to complete sexual function and HRQoL questionnaires
• Sexually active and potent (able to achieve an EPIC questionnaire sexual domain score greater than or equal to 75 without the use of any devices or medicines to enhance erections)
• Prostate gland volume greater than or equal to 20cc and less than or equal to 60cc
• Does not have stress urinary incontinence defined as urinary leakage requiring the use of any protective pads
• Most recent serum PSA \<10 ng/mL taken at least 6 weeks after a previous biopsy and 3 months +/- 2 weeks prior to study cryoablation
• Histologically proven, clinical stage T1c-T2b prostate cancer in the proposed treated side
• Untreated contralateral side has no malignant elements demonstrated by biopsy
• Patient does not have ASAP (Atypical Small Acinar Proliferation) in the untreated side
• Patient has documented, biopsy proven unilateral disease (via a minimum of 6 biopsy cores taken on the cancerous side and a minimum of 12 negative cores on the non-cancerous side) using transrectal ultrasound (TRUS) guidance
• A 12 core biopsy using transrectal ultrasound (TRUS) guidance taken within 3 months prior to enrollment from the non-cancerous side and each core was biopsied by a site investigator
• Biopsied areas in the non-cancerous side include the following zones: L/R (left or right side) lateral base, L/R mid gland base, L/R medial base, L/R lateral middle, L/R mid gland middle, L/R medial middle, L/R lateral apex, L/R mid gland apex, L/R medial apex, L/R transitional base, L/R transitional mid, L/R anterior horn
• Prostate biopsy Gleason Score (GS) is less than or equal to 7. Gleason Score 3+4=7 \[but not 4+3=7\] is allowed as long as the score is based upon no more than 2 cores with cancer involvement of 50% or less.
• Does not have a biopsy GS 3+4=7 combined with clinical stage T2b

You may not qualify if:

• Previous treatment for prostate cancer including radiation, cryoablation, chemotherapy, surgery, high intensity focused ultrasound, and/or hormone therapy
• Previous invasive or minimally invasive treatment for benign prostatic hypertrophy (BPH) (i.e., TURP, TUMPT, WIT, TUNA)
• Inability to tolerate a transrectal ultrasound
• Active urinary tract infection
• Evidence of metastatic disease
• Irreversible bleeding diathesis or other bleeding disorders
• Anatomic penile abnormalities precluding cryoablation
• Erectile dysfunction (EPIC Questionnaire sexual domain score \<60) at baseline, including the use of any erectile aid (PDE-5, etc) to increase the EPIC Questionnaire (Appendix D) sexual domain score \>75, without which the patient would not qualify for the study
• Current or history within the past 6 months of alcohol and/or substance abuse which would impair participation in the study
• Major medical disorder (i.e. uncontrolled diabetes, significant hepatic, renal, or hematological disorders, recent stroke or myocardial infarction), in the opinion of the urologist, is an illness or complication which is not consistent with the protocol requirements
• Unwilling to undergo the necessary follow-up for the trial period
• Bilateral prostate cancer disease
• Significant median lobe of the prostate which would preclude an adequate cryoablation procedure (based on the discretion of the urologist)
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrythmia, or psychiatric illness/social situations which would limit compliance with study requirements
• Known HIV or AIDS-related illness

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Winthrop Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Aaron E Katz, MD

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: June 2, 2015
• Study Start: April 1, 2015
• Primary Completion: April 26, 2018
• Study Completion: April 26, 2018
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

US (1)