Study of Focal Cryoablation in Low-Risk Prostate Cancer

NCT00774436 | Completed Phase 2

• 1 other identifier: 08-118
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

focal cryotherapy; low-risk prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• To evaluate treatment related tissue changes with ultrasound imaging

  prior to performing the biopsy

• To evaluate treatment related tissue changes with ultrasound imaging

  at the 6-8 month patient office visit

Study Arms (1)

Patients scheduled to receive Focal Cryotherapy

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.

Procedure: focal cryotherapy

Interventions

focal cryotherapy 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).

Patients scheduled to receive Focal Cryotherapy

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• James Eastham, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 17, 2008
• Study Start: October 14, 2008
• Primary Completion: July 23, 2019
• Study Completion: July 23, 2019
• Last Updated: July 29, 2019

Record last verified: 2018-10

Locations

US (1)