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Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy


N/A
20 Years
N/A
Open (Enrolling)
Male
Prostate Cancer, Immune Profile, Circulating Cancer Cells, Clinical Corelation

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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

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