Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
National Taiwan University Hospital Identifier:
First received: October 13, 2011
Last updated: November 12, 2012
Last verified: March 2012
The change of immune profiles and existence of circulating tumor cells following prostate cryotherapy may be correlated with the clinical outcome.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Cancer recurrence [ Time Frame: 3, 6, 12, 24 months after treatments ] [ Designated as safety issue: No ]


    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:
  • Quality of life [ Time Frame: 3, 6, 12, 24months after treatments ] [ Designated as safety issue: No ]
    according to the QLQ C30 and PR25 questionnaire interview

Estimated Enrollment: 160
Study Start Date: October 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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


Ages Eligible for Study:   20 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital Identifier: NCT01454037     History of Changes
Other Study ID Numbers: 201107059RB
Study First Received: October 13, 2011
Last Updated: November 12, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Neoplastic Cells, Circulating
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes processed this record on November 27, 2015