Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment focal cryotherapy
Phase phase 2
Sponsor Memorial Sloan Kettering Cancer Center
Start date October 2008
End date October 2017
Trial size 50 participants
Trial identifier NCT00774436, 08-118

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
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).

Primary Outcomes

Measure
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.
time frame: conclusion of the study

Secondary Outcomes

Measure
To evaluate the change from baseline in quality-of-life indicators following focal cryoablation in patients with low-risk localized prostate cancer.
time frame: conclusion of the study
To evaluate treatment related tissue changes with ultrasound imaging
time frame: prior to performing the biopsy
To evaluate treatment related tissue changes with ultrasound imaging
time frame: at the 6-8 month patient office visit

Eligibility Criteria

Male participants at least 21 years old.

A two-step consenting process will be in place for all patients being enrolled to this study. The two-step method is necessary because all patients being enrolled will need to have a repeat transrectal biopsy after meeting the initial study requirements. The two step consent process would enroll patients considering focal cryotherapy into the initial part of the study (QOL assessment at baseline, PCA3 test, and repeat biopsy); those deemed eligible after the re-staging biopsy would be consented to participate in the remainder of the study (focal cryotherapy, QOL studies, repeat biopsy at 6 months for efficacy, PCA3 test). First Step Enrollment 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)

Additional Information

Official title A Phase II Study of Focal Cryoablation in Low-Risk Prostate Cancer
Principal investigator James Eastham, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.