Aggressive Prostate Cancers in Elderly Patients
This study has been completed.
Sponsor:
Seoul National University Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01347476
First received: April 29, 2011
Last updated: May 18, 2011
Last verified: May 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 29, 2011 | ||||
| Last Updated Date | May 18, 2011 | ||||
| Start Date ICMJE | January 2010 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
biochemical recurrences (BCR) [ Time Frame: 5 year-BCR ] [ Designated as safety issue: No ] BCR was defined as two consecutive increasing PSA values of more than 0.2 ng/mL |
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01347476 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
pathologic outcomes [ Time Frame: postoperative 1 week ] [ Designated as safety issue: No ] biopsy or pathologic Gleason scores, mean percent of positive cores and tumor volume percent, Extracapsular extension and seminal vesicle invasion |
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Aggressive Prostate Cancers in Elderly Patients | ||||
| Official Title ICMJE | Patients Aged More Than 70 Had More Aggressive Prostate Cancers and Higher Risk of Biochemical Recurrence in Korea | ||||
| Brief Summary | Patients aged 70 years or older had a higher possibility of high risk cancer than younger patients. |
||||
| Detailed Description | Patients aged 70 years or older had a higher risk of advanced prostate cancer and shorter BCR-free survival than younger ones. Definite treatment of clinically localized prostate cancer should be actively considered in well-selected healthy patients older than 70 years. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Men who underwent radical prostatectomy for the treatment of clinically localized prostate cancer |
||||
| Condition ICMJE | Prostatic Neoplasms | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
|
||||
| Publications * | Kim JK, Cho SY, Jeong CW, Lee SB, Ku JH, Hong SK, Byun SS, Kwak C, Him HH, Lee SE, Jeong H. Patients aged more than 70 had higher risk of locally advanced prostate cancers and biochemical recurrence in Korea. BJU Int. 2012 Aug;110(4):505-9. doi: 10.1111/j.1464-410X.2011.10927.x. Epub 2012 Feb 7. PubMed PMID: 22314007. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1333 | ||||
| Completion Date | October 2010 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Male | ||||
| Ages | 40 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01347476 | ||||
| Other Study ID Numbers ICMJE | old age prostate, elderly pts with high risk CaP | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Seoul National University Boramae Hospital | ||||
| Study Sponsor ICMJE | Seoul National University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Seoul National University Hospital | ||||
| Verification Date | May 2011 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||