Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01454037
Recruitment Status : Unknown
Verified March 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : October 18, 2011
Last Update Posted : November 14, 2012
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
The change of immune profiles and existence of circulating tumor cells following prostate cryotherapy may be correlated with the clinical outcome.

Condition or disease Intervention/treatment
Prostate Cancer Immune Profile Circulating Cancer Cells Clinical Corelation Procedure: Prostate cryotherapy Procedure: Radical prostatectomy Procedure: Radiation

Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy
Study Start Date : October 2011
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Prostate cryoablation
Subjects receiving cryotherapy for prostate cancer
Procedure: Prostate cryotherapy
cryoablate the prostate
Radical prostatectomy
Subjects receiving radical prostatectomy
Procedure: Radical prostatectomy
Remove prostate
Subjects receiving radiation for prostate cancer
Procedure: Radiation
Radiate prostate

Primary Outcome Measures :
  1. Cancer recurrence [ Time Frame: 3, 6, 12, 24 months after treatments ]


    1. Biochemical (PSA) recurrence according to the ASTRO or Phoenix criteria for patients undergoing cryotherapy (Cryo) or radiotherapy (RT)
    2. Prostate biopsy positivity
    3. Radiographic evidence of recurrence (CT/MRI, Bone scan, radiographs, etc.) Time to recurrence defined by the either of the above 3 outcome parameters

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 3, 6, 12, 24months after treatments ]
    according to the QLQ C30 and PR25 questionnaire interview

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Taiwanese organ-confined or locally advanced prostate cancer patients

Inclusion Criteria:

  • Age>20 years
  • Histopathology-proven prostate adenocarcinoma
  • Non-metastatic localized disease
  • Subjects have chosen their curative, definitive treatments for prostate cancer prior to enrolling for the study
  • Subjects are willing to sign the informed consent and agree to comply with the study procedures

Exclusion Criteria:

  • Chronic use (> 2 weeks) of > 10 mg/day of prednisone or prednisolone within 2 months of the screening (topical or inhalational corticosteroids are permitted)
  • Concurrent use of immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 3 months of study entry
  • Other conditions the investigators think may affect subjects' compliance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01454037

Contact: Yeong-Shiau Pu, PhD 886-2-23123456 ext 65249

National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Yeong-Shiau Pu, PhD    886-2-23123456 ext 65249   
Principal Investigator: Yeong-Shiau Pu, Prof.         
Sub-Investigator: Chung-Hsin Chen, MD         
Sub-Investigator: HJ Yu, Prof.         
Sub-Investigator: CY Huang, MD         
Sub-Investigator: SM Wang, MD         
Sub-Investigator: HC Tai, MD         
Sub-Investigator: SP Lui, MD         
Sub-Investigator: WJ Lin, MD         
Sub-Investigator: JS Chen, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Yeong-Shiau Pu, PhD National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital Identifier: NCT01454037     History of Changes
Other Study ID Numbers: 201107059RB
First Posted: October 18, 2011    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Neoplastic Cells, Circulating
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes