Prostate CancerNCT01454037
Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy
An observational study of Prostate Cancer and Immune Profile, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The change of immune profiles and existence of circulating tumor cells following prostate cryotherapy may be correlated with the clinical outcome. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Prostate Cancer, Immune Profile, Circulating Cancer Cells
- What is being tested?
- Prostate cryotherapy, Radical prostatectomy and Radiation
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2011to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Taiwanese organ-confined or locally advanced prostate cancer patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Yeong-Shiau Pu, PhD, 886-2-23123456 ext. 65249, yspu@ntu.edu.tw
Yeong-Shiau Pu, Prof.
About this study
The change of immune profiles and existence of circulating tumor cells following prostate cryotherapy may be correlated with the clinical outcome.
- Being tested
- Prostate cryotherapy, Radical prostatectomy, Radiation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate cryotherapyProcedure or surgery
cryoablate the prostate
Radical prostatectomyProcedure or surgery
Remove prostate
RadiationProcedure or surgery
Radiate prostate
| Study group | Role | What they receive |
|---|---|---|
| Prostate cryoablation | Subjects receiving cryotherapy for prostate cancer Receives: Procedure: Prostate cryotherapy | |
| Radical prostatectomy | Subjects receiving radical prostatectomy Receives: Procedure: Radical prostatectomy | |
| Radiation | Subjects receiving radiation for prostate cancer Receives: Procedure: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3, 6, 12, 24 months after treatments
Secondary outcomes (1)
Quality of life
according to the QLQ C30 and PR25 questionnaire interview
Measured: 3, 6, 12, 24months after treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2013 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yeong-Shiau Pu, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454037
- Sponsor's protocol ID
- 201107059RB
- Status last verified
- Mar 2012
- First submitted
- 13 Oct 2011
- Last updated
- 14 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy
- ClinicalTrials.gov ID
- NCT01454037
- Acronym / sponsor ID
- 201107059RB
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 18 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The change of immune profiles and existence of circulating tumor cells following prostate cryotherapy may be correlated with the clinical outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prostate cryoablation | – | Procedure: Prostate cryotherapySubjects receiving cryotherapy for prostate cancer |
| Radical prostatectomy | – | Procedure: Radical prostatectomySubjects receiving radical prostatectomy |
| Radiation | – | Procedure: RadiationSubjects receiving radiation for prostate cancer |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Taiwanese organ-confined or locally advanced prostate cancer patients
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate cryotherapycryoablate the prostate | Procedure or surgery | Prostate cryoablation |
| Radical prostatectomyRemove prostate | Procedure or surgery | Radical prostatectomy |
| RadiationRadiate prostate | Procedure or surgery | Radiation |
Primary outcome
Cancer recurrence
Time frame: 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
1 secondary outcome
Quality of life
Time frame: 3, 6, 12, 24months after treatments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeong-Shiau Pu, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Immune Profile, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yeong-Shiau Pu, PhD (886-2-23123456 ext. 65249, yspu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer recurrence (time frame: 3, 6, 12, 24 months after treatments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2012.