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Completed

NCT Number: NCT00774436

Study of Focal Cryoablation in Low-Risk Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

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.

    Time frame: conclusion of the study

Secondary outcomes

  1. 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

  2. To evaluate treatment related tissue changes with ultrasound imaging

    Time frame: prior to performing the biopsy

    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.

  3. To evaluate treatment related tissue changes with ultrasound imaging

    Time frame: at the 6-8 month patient office visit

    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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2019
Study completion
2019
First posted
Oct 17, 2008
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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