Trial Information
Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Cancer recurrence
Outcome Description:
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
Outcome Time Frame:
3, 6, 12, 24 months after treatments
Safety Issue:
No
Principal Investigator
Yeong-Shiau Pu, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Taiwan University Hospital
Authority:
Taiwan: Department of Health
Study ID:
201107059RB
NCT ID:
NCT01454037
Start Date:
October 2011
Completion Date:
October 2015
Related Keywords:
- Prostate Cancer
- Immune Profile
- Circulating Cancer Cells
- Clinical Corelation
- Neoplastic Cells, Circulating
- Prostatic Neoplasms