Study of Focal Cryoablation in Low-Risk Prostate Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Procedure: focal cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00774436

08-118

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Patients scheduled to receive Focal Cryotherapy

Experimental group

Description:

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.

Treatment:

Procedure: focal cryotherapy