Study of Focal Cryoablation in Low-Risk Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Phase II Study of Focal Cryoablation in Low-Risk Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00774436
• Other study ID #: 08-118
• Status: Completed
• Phase: Phase 2
• Start date: October 14, 2008
• Est. completion date: July 23, 2019

Study information

• Verified date: October 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 23, 2019
• Est. primary completion date: July 23, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• 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).

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	To evaluate treatment related tissue changes with ultrasound imaging	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.	prior to performing the biopsy
Secondary	To evaluate treatment related tissue changes with ultrasound imaging	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.	at the 6-8 month patient office visit

External Links

•   Memorial Sloan-Kettering Cancer Center