Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy

• Conditions: Prostate Cancer; Immune Profile; Circulating Cancer Cells; Clinical Corelation
• Interventions: Procedure: Prostate cryotherapy; Procedure: Radical prostatectomy; Procedure: Radiation

• Registration Number: NCT01454037
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-10-17
• Study First Posted: 2011-10-18
• Status Verified: 2012-03
• Last Update Submitted: 2012-11-12
• Last Update Posted: 2012-11-14
• Primary Completion: 2013-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 160

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prostate cryoablation	Prostate cryotherapy	Subjects receiving cryotherapy for prostate cancer
Radical prostatectomy	Radical prostatectomy	Subjects receiving radical prostatectomy
Radiation	Radiation	Subjects receiving radiation for prostate cancer

Primary Outcome Measures

Name	Time	Method
Cancer recurrence	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

Secondary Outcome Measures

Name	Time	Method
Quality of life	3, 6, 12, 24months after treatments	according to the QLQ C30 and PR25 questionnaire interview

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan