Pre-Prostatectomy Celecoxib or Placebo
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|ClinicalTrials.gov Identifier: NCT02840162|
Recruitment Status : Terminated (Drug safety concerns)
First Posted : July 21, 2016
Last Update Posted : April 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Prostate Prostate Cancer||Drug: Celecoxib Drug: Placebo||Phase 2|
I. To determine if COX-2 inhibition with celecoxib significantly increases apoptosis in human adenocarcinoma of the prostate.
I. To determine if COX-2 inhibition with celecoxib reduces levels of Prostaglandin E2 and androgen receptor in fresh tumor tissue collected at prostatectomy
II. To collect pre- and postoperative serum Prostate Specific Antigen (PSA) for exploratory analyses
III. To determine the effect of celecoxib on adverse effects, perioperative surgical complications and post surgery analgesic use
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Randomized Study of Pre-Prostatectomy Celecoxib or Placebo|
|Study Start Date :||May 2001|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||May 2011|
Active Comparator: Celecoxib
Treated patients will receive 4 weeks of celecoxib at 400 mg twice daily by mouth
Selective inhibition of COX-2 without significant cyclooxygenase-1 (COX-1) inhibition
Placebo Comparator: Placebo
Control patients will receive a suitable placebo for 4 weeks, twice daily by mouth
- Apoptosis Index, defined as the percent positive staining cells [ Time Frame: approximately 4 weeks of treatment ]Percent positively staining cells with a minimum of 1000 total cells counted. Descriptive statistics will be conducted. The apoptotic index will be reported with 95% confidence intervals.
- Prostaglandin and Androgen Receptor Levels [ Time Frame: approximately 4 weeks of treatment ]Descriptive statistical analysis will be conducted. The estimates will be reported with 95% confidence intervals.
- Percent Change in Median PSA Values, pre- and postoperatively [ Time Frame: approximately 4 weeks of treatment ]Pre- and postoperative PSA will be collected. Descriptive statistics will be conducted, comparing preoperative PSA level to postoperative level.
- Perioperative Analgesic Use, using morphine equivalents [ Time Frame: Prostatectomy to discharge from hospital, no more than 30 days post prostatectomy ]Descriptive statistical analysis will be conducted. The estimate will be calculated using morphine equivalents dividend by length of hospital stay and reported with 95% confidence intervals.
- Surgical Complications, defined as incidence of adverse events determined to be related to surgery graded by NCI CTCAE version 2.0 [ Time Frame: Intraoperatively to 30 days postoperatively ]Intraoperative and post surgical complications will be collected and reported.
- Incidence of Adverse Events, graded by NCI CTCAE version 2.0 [ Time Frame: From start of treatment to 30 days post prostatectomy ]Descriptive statistical analysis will be conducted
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840162
|United States, Oregon|
|Portland VA Medical Center|
|Portland, Oregon, United States, 97207|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Tomasz M Beer, MD||OHSU Knight Cancer Institute|