Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01454037

Enrollment

160

Registered

2011-10-18

Start date

2011-10-31

Completion date

2015-10-31

Last updated

2012-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Interventions

PROCEDUREProstate cryotherapy

cryoablate the prostate

PROCEDURERadical prostatectomy

Remove prostate

PROCEDURERadiation

Radiate prostate

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Taiwan

Contacts

Primary ContactYeong-Shiau Pu, PhD

yspu@ntu.edu.tw886-2-23123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026