Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy

November 12, 2012 updated by: National Taiwan University Hospital
The change of immune profiles and existence of circulating tumor cells following prostate cryotherapy may be correlated with the clinical outcome.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Yeong-Shiau Pu, PhD
          • Phone Number: 65249 886-2-23123456
          • Email: 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Taiwanese organ-confined or locally advanced prostate cancer patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer recurrence
Time Frame: 3, 6, 12, 24 months after treatments

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
3, 6, 12, 24 months after treatments

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 3, 6, 12, 24months after treatments
according to the QLQ C30 and PR25 questionnaire interview
3, 6, 12, 24months after treatments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Yeong-Shiau Pu, PhD, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

October 13, 2011

First Submitted That Met QC Criteria

October 17, 2011

First Posted (Estimate)

October 18, 2011

Study Record Updates

Last Update Posted (Estimate)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 12, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201107059RB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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