Clinical trial NCT00774436: Study of Focal Cryoablation in Low-Risk Prostate Cancer
Official title: A Phase II Study of Focal Cryoablation in Low-Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: focal cryotherapy
low-risk prostate cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-10-17
Enrollment: 12
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

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.
timeFrame: 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.
timeFrame: conclusion of the study
measure: To evaluate treatment related tissue changes with ultrasound imaging
timeFrame: prior to performing the biopsy
measure: To evaluate treatment related tissue changes with ultrasound imaging
timeFrame: at the 6-8 month patient office visit
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: James Eastham, MD
role: PRINCIPAL_INVESTIGATOR
References: