Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy

NCT01454037 | Unknown

• 1 other identifier: 201107059RB
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer; Immune Profile; Circulating Cancer Cells; Clinical Corelation

Outcome Measures

Primary Outcomes (1)

• Cancer recurrence

  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 Outcomes (1)

• Quality of life

  3, 6, 12, 24months after treatments

Study Arms (3)

Prostate cryoablation

Subjects receiving cryotherapy for prostate cancer

Procedure: Prostate cryotherapy

Radical prostatectomy

Subjects receiving radical prostatectomy

Procedure: Radical prostatectomy

Radiation

Subjects receiving radiation for prostate cancer

Procedure: Radiation

Interventions

Prostate cryotherapy PROCEDURE

cryoablate the prostate

Prostate cryoablation

Radical prostatectomy PROCEDURE

Remove prostate

Radical prostatectomy

Radiation PROCEDURE

Radiate prostate

Radiation

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Taiwanese organ-confined or locally advanced prostate cancer patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Yeong-Shiau Pu, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeong-Shiau Pu, PhD

CONTACT

886-2-23123456; yspu@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 18, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2015
• Last Updated: November 14, 2012

Record last verified: 2012-03

Locations

TW (1)