Pre-Prostatectomy Celecoxib or Placebo

NCT02840162 | Terminated Phase 2 DMC

• 2 other identifiers: IRB00001004HOR-01019-L
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

Adenocarcinoma of the Prostate; Prostate Cancer

Keywords

prostate cancer; NSAIDs; chemoprevention; celecoxib; COX-2 inhibitors

Outcome Measures

Primary Outcomes (1)

• Apoptosis Index, defined as the percent positive staining cells

  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.

  approximately 4 weeks of treatment

Secondary Outcomes (5)

• Prostaglandin and Androgen Receptor Levels

  approximately 4 weeks of treatment

• Percent Change in Median PSA Values, pre- and postoperatively

  approximately 4 weeks of treatment

• Perioperative Analgesic Use, using morphine equivalents

  Prostatectomy to discharge from hospital, no more than 30 days post prostatectomy

• Surgical Complications, defined as incidence of adverse events determined to be related to surgery graded by NCI CTCAE version 2.0

  Intraoperatively to 30 days postoperatively

• Incidence of Adverse Events, graded by NCI CTCAE version 2.0

  From start of treatment to 30 days post prostatectomy

Study Arms (2)

Celecoxib

ACTIVE COMPARATOR

Treated patients will receive 4 weeks of celecoxib at 400 mg twice daily by mouth

Drug: Celecoxib

Placebo

PLACEBO COMPARATOR

Control patients will receive a suitable placebo for 4 weeks, twice daily by mouth

Drug: Placebo

Interventions

Celecoxib DRUG

Selective inhibition of COX-2 without significant cyclooxygenase-1 (COX-1) inhibition

Also known as: Celebrex, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl], Benzenesulfonamide

Celecoxib

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Pfizer: collaborator

Study Sites (2)

Portland VA Medical Center

Portland, Oregon, 97207, United States

Location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Celecoxib; Benzenesulfonamides

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tomasz M Beer, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 21, 2016
• Study Start: May 1, 2001
• Primary Completion: January 1, 2005
• Study Completion: May 1, 2011
• Last Updated: April 28, 2017

Record last verified: 2017-04

Locations

US (2)