|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | October 15, 2008 | ||||||||
| Last Updated Date | March 10, 2010 | ||||||||
| Start Date ICMJE | October 2008 | ||||||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00774436 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of Focal Cryoablation in Low-Risk Prostate Cancer | ||||||||
| Official Title ICMJE | A Phase II Study of Focal Cryoablation in Low-Risk Prostate Cancer | ||||||||
| 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. |
||||||||
| Detailed Description | |||||||||
| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment | ||||||||
| Condition ICMJE | Prostate Cancer | ||||||||
| Intervention ICMJE | 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). |
||||||||
| Study Arms / Comparison Groups | 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.
Intervention: Procedure: focal cryotherapy |
||||||||
| Publications * | |||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | October 2011 | ||||||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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:
Second Step Enrollment Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Male | ||||||||
| Ages | 21 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00774436 | ||||||||
| Responsible Party | James Eastham, MD, Memorial Sloan-Kettering Cancer Center | ||||||||
| Study ID Numbers ICMJE | 08-118 | ||||||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||||||
| Verification Date | March 2010 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
