Prostate CancerNCT01530295
Biochemical Recurrence Rate of Radical Prostatectomy Combined With Neoadjuvant and Adjuvant Chemotherapy in High Risk Prostate Cancer
A study testing DOCETAXEL in people with Prostate Cancer, run by Hanjong Ahn at 1 site in South Korea.
Trial summary
Effect of Radical Prostatectomy Combined with Neoadjuvant and Adjuvant Chemotherapy in Patients with High Risk Prostate Cancer. The purpose of this study is to evaluate whether neoajuvant and adjuvant docetaxel and prednisone are effective in the treatment of high risk localized prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- DOCETAXEL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2008to Jul 2012
- Phase
- Interventional
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Prostate Cancer
- PSA > 20 OR
- Clinical Stage > T2C OR
- GS > 7
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jungmin Lee
Seoul, Seoul, 138-731
jungmin lee, NURSE, 82-2-3010-8461, agapeljm@naver.com
hanjong ahn, md
About this study
Official title: Biochemical Recurrence Rate of Radical Prostatectomy Combined With Neoadjuvant and Adjuvant in Patients With High Risk Locallized Prostate Cancer
Effect of Radical Prostatectomy Combined with Neoadjuvant and Adjuvant Chemotherapy in Patients with High Risk Prostate Cancer.
The purpose of this study is to evaluate whether neoajuvant and adjuvant docetaxel and prednisone are effective in the treatment of high risk localized prostate cancer.
Read the detailed description
The purpose of this study is to evaluate whether neoajuvant and adjuvant docetaxel and prednisone are effective in the treatment of high risk localized prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- DOCETAXEL
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOCETAXELDrug
Also called taxotere
75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: 3 times pre-op and 3 times after surgery
| Study group | Role | What they receive |
|---|---|---|
| contol | No intervention | control group Receives: Drug: DOCETAXEL |
| chemotherapy | Other | neoadjuvant chemotherapy Receives: Drug: DOCETAXEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
biochemical recurrence rate of Radical Prostatectomy Combined with Neoadjuvant and Adjuvant Chemotherapy in Patients with High Risk Prostate Cancer
Measured: 2 Years After RRP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startJul 2008
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanjong Ahn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hanjong Ahn, Asan Medical Center
- Investigators
- hanjong Ahn, Ph.D, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530295
- Sponsor's protocol ID
- 2007-0326
- Status last verified
- Feb 2012
- First submitted
- 22 Jun 2011
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical Recurrence Rate of Radical Prostatectomy Combined With Neoadjuvant and Adjuvant in Patients With High Risk Locallized Prostate Cancer
- ClinicalTrials.gov ID
- NCT01530295
- Acronym / sponsor ID
- 2007-0326
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hanjong AhnUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 9 Feb 2012 (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.
Effect of Radical Prostatectomy Combined with Neoadjuvant and Adjuvant Chemotherapy in Patients with High Risk Prostate Cancer.
The purpose of this study is to evaluate whether neoajuvant and adjuvant docetaxel and prednisone are effective in the treatment of high risk localized prostate cancer.
Detailed description
The purpose of this study is to evaluate whether neoajuvant and adjuvant docetaxel and prednisone are effective in the treatment of high risk localized prostate cancer.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| contol | No intervention | Drug: DOCETAXELcontrol group |
| chemotherapy | Other | Drug: DOCETAXELneoadjuvant chemotherapy |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Prostate Cancer
- PSA > 20 OR
- Clinical Stage > T2C OR
- GS > 7
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| DOCETAXELAlso: taxotere75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: 3 times pre-op and 3 times after surgery | Drug | chemotherapy, contol |
Primary outcome
biochemical recurrence rate of Radical Prostatectomy Combined with Neoadjuvant and Adjuvant Chemotherapy in Patients with High Risk Prostate Cancer
Time frame: 2 Years After RRP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 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.
hanjong Ahn, Ph.D principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DOCETAXEL in people with Prostate Cancer, run by Hanjong Ahn at 1 site in South Korea.
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 4 inclusion and 0 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 9 Feb 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 South Korea. 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 HANJONG AHN, MD (82-2-3010-3733, hjahn@amc.seoul.kr, agapeljm@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biochemical recurrence rate of Radical Prostatectomy Combined with Neoadjuvant and Adjuvant Chemotherapy in Patients with High Risk Prostate Cancer (time frame: 2 Years After RRP). 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 9 Feb 2012.