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Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy

This study is currently recruiting participants.
Verified March 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01454037
First received: October 13, 2011
Last updated: November 12, 2012
Last verified: March 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ]

    Includes:

    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
Radiation
Subjects receiving radiation for prostate cancer
 Procedure: Radiation
Radiate prostate

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454037

Contacts
Contact: Yeong-Shiau Pu, PhD 886-2-23123456 ext 65249 yspu@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Yeong-Shiau Pu, PhD     886-2-23123456 ext 65249     yspu@ntu.edu.tw    
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
Investigators
Principal Investigator: Yeong-Shiau Pu, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov 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
Prostatic Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
 Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013