Clinical trial NCT02840162: Pre-Prostatectomy Celecoxib or Placebo
Official title: Randomized Study of Pre-Prostatectomy Celecoxib or Placebo
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Adenocarcinoma of the Prostate
Prostate Cancer
Keywords: prostate cancer
NSAIDs
chemoprevention
celecoxib
COX-2 inhibitors
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2016-07-21
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will seek to determine if the downstream effects of cyclooxygenase-2 (COX-2) inhibition suggested by preclinical systems occur in human prostate cancer. To answer this question, men who have chosen prostatectomy will be randomly assigned to preoperative treatment with celecoxib or placebo for four weeks. Carefully collected tumor, premalignant, and benign prostate tissue will then be examined for apoptosis, androgen receptor and prostaglandin E2 levels. Tumor COX-2 expression will be correlated with observed treatment effects. The data generated by this study will serve as a foundation for the development of COX-2 targeted therapies for prostate cancer, will provide preliminary evidence for larger scale clinical trials aimed at treatment and prevention of prostate cancer, and will validate current preclinical models used to study COX-2 in prostate cancer.

Detailed description: PRIMARY OBJECTIVE

I. To determine if COX-2 inhibition with celecoxib significantly increases apoptosis in human adenocarcinoma of the prostate.

SECONDARY OBJECTIVES

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

Eligibility criteria: Inclusion Criteria:

* Histopathologically or cytologically proven adenocarcinoma of the prostate and planned prostatectomy
* Age \>= 18
* Performance status (ECOG \<= 2)
* Hemoglobin \> 10 g/dL (within 4 weeks)
* Creatinine \<= 1.5 mg/dL
* Signed informed patient consent

Exclusion Criteria:

* Other preoperative or prior treatment directed at prostate cancer
* Significant active medical illness which in the opinion of the investigator would preclude protocol treatment
* Use of non-steroidal anti-inflammatory agents within seven days of celecoxib treatment
* Hypersensitivity to celecoxib
* A history of asthma, urticaria, or anaphylaxis precipitated by an NSAID
* History of significant upper gastrointestinal bleeding or active peptic ulcer disease
* Current treatment with anticoagulants
* Allergy to sulfonamide

Primary outcomes:
measure: Apoptosis Index, defined as the percent positive staining cells
timeFrame: approximately 4 weeks of treatment
Secondary outcomes:
measure: Prostaglandin and Androgen Receptor Levels
timeFrame: approximately 4 weeks of treatment
measure: Percent Change in Median PSA Values, pre- and postoperatively
timeFrame: approximately 4 weeks of treatment
measure: Perioperative Analgesic Use, using morphine equivalents
timeFrame: Prostatectomy to discharge from hospital, no more than 30 days post prostatectomy
measure: Surgical Complications, defined as incidence of adverse events determined to be related to surgery graded by NCI CTCAE version 2.0
timeFrame: Intraoperatively to 30 days postoperatively
measure: Incidence of Adverse Events, graded by NCI CTCAE version 2.0
timeFrame: From start of treatment to 30 days post prostatectomy
Other outcomes:
Locations:
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Tomasz M Beer, MD
role: PRINCIPAL_INVESTIGATOR
References: