Study of Focal Cryoablation in Low-Risk Prostate Cancer

NCT ID: NCT00774436

Last Updated: 2019-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-14
• Study Completion Date: 2019-07-23

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients scheduled to receive Focal Cryotherapy

After enrollment, patients will undergo a repeat transrectal ultrasound- guided prostate biopsy (minimum of 12 cores) to confirm the low-risk nature of their cancer. For study purposes, patients must meet the original entry crieteria on this repeat biopsy. If the patient meets the repeat-biopsy enrollment criteria, they will be treated with focal cryotherapy, meaning cryoablation of the regions of the prostate containing cancer. Efficacy is defined as all negative biopsy cores at the site of the focal ablation on a repeat transrectal biopsy 6 months after cryoablation. At baseline (prior to the re-staging biopsy), 3 months after focal cryotherapy, and at 6 months after focal cryotherapy (prior to the repeat prostate biopsy used to define efficacy), the patient will complete quality of life questionnaires as standard for all patients in the Urology Service.

Group Type: EXPERIMENTAL

focal cryotherapy

Intervention Type: PROCEDURE

Those men meeting the re-staging biopsy criteria will subsequently be treated with focal cryotherapy. Clinical follow-up visits will be scheduled at 6 + 2 weeks, 3 + 1 months and 6 + 1 months after focal cryotherapy, at which time, a digital rectal examination and PSA test will be performed. Standard quality-of-life questionnaires, are completed by all patients treated by the Urology Service (whether on not they are treated on an IRB protocol).

Interventions

focal cryotherapy

Those men meeting the re-staging biopsy criteria will subsequently be treated with focal cryotherapy. Clinical follow-up visits will be scheduled at 6 + 2 weeks, 3 + 1 months and 6 + 1 months after focal cryotherapy, at which time, a digital rectal examination and PSA test will be performed. Standard quality-of-life questionnaires, are completed by all patients treated by the Urology Service (whether on not they are treated on an IRB protocol).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

First Step Enrollment

• 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

• 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)

Second Step Enrollment

• 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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Eastham, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org

Memorial Sloan-Kettering Cancer Center

Other Identifiers

08-118

Identifier Type: -

Identifier Source: org_study_id