Study of Focal Cryoablation in Low-Risk Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00774436
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to find out if men, with low-risk prostate, can have the small amount of cancer within their prostate removed by freezing, called Focal Cryoablation or Cryotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-14
• Study First Submitted: 2008-10-15
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-17
• Status Verified: 2018-10
• Primary Completion: 2019-07-23
• Study Completion: 2019-07-23
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Men ≥ 21 years of age with a life expectancy estimated to be > 10-years.
• Diagnosis of adenocarcinoma of the prostate and confirmed by MSKCC review
• No prior treatment for prostate cancer
• ECOG performance status of 0 or 1
• Prostate cancer clinical stage T1c-T2a
• PSA < 10ng/mL (this will be the PSA level prompting the prostate biopsy)
• Prostate Size <60 cc on transrectal ultrasound

Exclusion Criteria

• Medically unfit for anesthesia
• Histology other than adenocarcinoma
• Men who have received any hormonal manipulation (antiandrogens; LHRH agonists) within the previous 6 months
• Men who are currently receiving anticoagulant drugs (e.g.: Coumadin, warfarin)

Second Step Enrollment

Inclusion Criteria:

• Repeat transrectal prostate biopsy that must meet the following parameters:
• Minimum of 12 biopsy cores
• No Biopsy Gleason grade 4 or 5
• Unilateral cancer (only right-sided or left-sided, not bilateral)
• No more than 50% cancer in any one biopsy core
• No more than 25% of cores containing cancer

Exclusion Criteria:

• Medically unfit for anesthesia
• Histology other than adenocarcinoma
• Men who have received any hormonal manipulation (antiandrogens; LHRH agonists) within the previous 6 months
• Men who are currently receiving anticoagulant drugs (e.g.: coumadin, warfarin)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess the local oncologic efficacy of focal cryoablation in men with low-risk, clinically localized prostate cancer, as measured by the ability to obtain all negative biopsy cores at the site of focal ablation of the cancer.	conclusion of the study

Secondary Outcome Measures

Name	Time	Method
To evaluate the change from baseline in quality-of-life indicators following focal cryoablation in patients with low-risk localized prostate cancer.	conclusion of the study
To evaluate treatment related tissue changes with ultrasound imaging	at the 6-8 month patient office visit	Ultrasound examination of the prostate performed at the time of biopsy procedures will be include archiving of 3D digital images to allow post-hoc analysis of the images to assess for tissue changes that may be characterized with imaging software.

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States