Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy

NCT ID: NCT01454037

Last Updated: 2012-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-10-31

Brief Summary

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

Detailed Description

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Conditions

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Prostate Cancer Immune Profile Circulating Cancer Cells Clinical Corelation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prostate cryoablation

Subjects receiving cryotherapy for prostate cancer

Prostate cryotherapy

Intervention Type PROCEDURE

cryoablate the prostate

Radical prostatectomy

Subjects receiving radical prostatectomy

Radical prostatectomy

Intervention Type PROCEDURE

Remove prostate

Radiation

Subjects receiving radiation for prostate cancer

Radiation

Intervention Type PROCEDURE

Radiate prostate

Interventions

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Prostate cryotherapy

cryoablate the prostate

Intervention Type PROCEDURE

Radical prostatectomy

Remove prostate

Intervention Type PROCEDURE

Radiation

Radiate prostate

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yeong-Shiau Pu, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yeong-Shiau Pu, PhD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Facility Contacts

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Yeong-Shiau Pu, PhD

Role: primary

Other Identifiers

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201107059RB

Identifier Type: -

Identifier Source: org_study_id