Pre-Prostatectomy Celecoxib or Placebo

OHSU Knight Cancer Institute

Status and phase

Terminated

Phase 2

Conditions

Adenocarcinoma of the Prostate

Prostate Cancer

Treatments

Drug: Placebo

Drug: Celecoxib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02840162

IRB00001004

HOR-01019-L (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment

34 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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