Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy

Prostate Cancer Clinical Trial

Official title:

Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01454037
• Other study ID #: 201107059RB
• Status: Recruiting
• Phase: N/A
• First received: October 13, 2011
• Last updated: November 12, 2012
• Start date: October 2011
• Est. completion date: October 2015

Study information

• Verified date: March 2012
• Source: National Taiwan University Hospital
• Contact: Yeong-Shiau Pu, PhD
• Phone: 886-2-23123456
• Email: yspu[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: October 2015
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Circulating Cancer Cells
• Clinical Corelation
• Immune Profile
• Neoplastic Cells, Circulating
• Prostate Cancer

Intervention

Procedure:
• Prostate cryotherapy
cryoablate the prostate
• Radical prostatectomy
Remove prostate
• Radiation
Radiate prostate

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer recurrence	Includes: Biochemical (PSA) recurrence according to the ASTRO or Phoenix criteria for patients undergoing cryotherapy (Cryo) or radiotherapy (RT); Prostate biopsy positivity; 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	No
Secondary	Quality of life	according to the QLQ C30 and PR25 questionnaire interview	3, 6, 12, 24months after treatments	No