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Cyclooxygenase-2 (COX-2) Inhibitor Reduces Serum Prostatic Specific Antigen (PSA) Levels

This study is currently recruiting participants.
Verified March 2013 by Buddhist Tzu Chi General Hospital
Sponsor:
Information provided by (Responsible Party):
Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT01678313
First received: August 29, 2012
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

To investigate the therapeutic effect and safety of celecoxib adding on doxazosin and the potential predictive value of the absence of prostate cancer in the treatment of patients with LUTS/BPH and an elevated serum PSA level.

Patients who meet all eligible requirements for entry into the study will be randomized into one of the two treatment groups for 3 months in 2:1 ratio as shown below:

  1. Celecoxib 200mg and doxazosin 4mg once daily
  2. Doxazosin 4mg once daily

Condition Intervention Phase
Benign Prostatic Hyperplasia
 Drug: Celecoxib 200mg and Doxazosin 4mg
Drug: Doxazosin 4mg
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: COX-2 Inhibitor Reduces Serum PSA Levels Might Predict a Lower Risk of Prostatic Cancer in Men With LUTS/BPH With an Elevated PSA Level

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Buddhist Tzu Chi General Hospital:

Primary Outcome Measures:
  • Change from Baseline in the serum prostate specific antigen (PSA) level [ Time Frame: Baseline to 3 months after initial treatment ] [ Designated as safety issue: Yes ]

    Efficacy:

    • Change from Baseline in the serum PSA level from baseline to 3 months

    Safety:

    • Systemic adverse events


Secondary Outcome Measures:
  • Change from Baseline in the International Prostate Symptom Score (IPSS) questionnaires [ Time Frame: Baseline to 3 months after initial treatment ] [ Designated as safety issue: Yes ]

    Change from Baseline in the total International Prostate Symptom Score (IPSS) and IPSS QoL score from baseline to 3 months after initial treatment

    Safety:

    Systemic adverse events


  • Change from Baseline in the total prostate volume (TPV) [ Time Frame: Baseline to 3 months after initial treatment ] [ Designated as safety issue: Yes ]

    Efficacy:

    Change from Baseline in the voiding and urodynamic parameter from baseline to 3 months:

    • Total prostate volume (TPV)

    Safety:

    Systemic adverse events


  • Change from Baseline in the transitional zone index (TZI) [ Time Frame: Baseline to 3 months after initial treatment ] [ Designated as safety issue: Yes ]

    Efficacy:

    Change from Baseline in the voiding and urodynamic parameter from baseline to 3 months:

    • Transitional zone index (TZI)

    Safety:

    Systemic adverse events


  • Change from Baseline in the maximum flow rate (Qmax) [ Time Frame: Baseline to 3 months after initial treatment ] [ Designated as safety issue: Yes ]

    Efficacy:

    Change from Baseline in the voiding and urodynamic parameter from baseline to 3 months:

    • Maximum flow rate (Qmax)

    Safety:

    Systemic adverse events


  • Change from Baseline in the voided volume [ Time Frame: Baseline to 3 months after initial treatment ] [ Designated as safety issue: Yes ]

    Efficacy:

    Change from Baseline in the voiding and urodynamic parameter from baseline to 3 months:

    • Voided volume

    Safety:

    Systemic adverse events


  • Change from Baseline in the postvoid residual volume (PVR) [ Time Frame: Baseline to 3 months after initial treatment ] [ Designated as safety issue: Yes ]

    Efficacy:

    Change from Baseline in the voiding and urodynamic parameter from baseline to 3 months:

    • Postvoid residual volume (PVR)

    Safety:

    Systemic adverse events


  • Change from Baseline in the serum free prostate specific antigen (PSA) level [ Time Frame: Baseline to 3 months after initial treatment ] [ Designated as safety issue: Yes ]

    Efficacy:

    Change from Baseline in the serum free PSA level from baseline to 3 months after initial treatment

    Safety:

    Systemic adverse events


  • Change from Baseline in the serum serum C-reactive protein level [ Time Frame: Baseline to 3 months after initial treatment ] [ Designated as safety issue: Yes ]

    Efficacy:

    Change from Baseline in the serum C-reactive protein level from baseline to 3 months after initial treatment

    Safety:

    Systemic adverse events



Estimated Enrollment: 90
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study group
Celecoxib 200mg and Doxazosin 4mg
 Drug: Celecoxib 200mg and Doxazosin 4mg
Study group
Other Names:
  • - Celecoxib 200mg
  • - Doxazosin 4mg
Experimental: Control group
Doxazosin 4mg
 Drug: Doxazosin 4mg
Control group
Other Name: - Doxazosin 4mg

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male adults aged ≥ 40 years with LUTS/BPH, IPSS ≥ 8
  • Free of active urinary tract infection
  • Free of neurogenic voiding dysfunction
  • No history of previous prostate biopsy within 6 months
  • No treatment of BPH by alpha-blocker or 5-alpha-reductase inhibitor within 6 months
  • Patient or his legally acceptable representative has signed the written informed consent form

Exclusion Criteria:

  • Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
  • Patients with acute r chronic urinary retention and urodynamically proven detrusor underactivity
  • Patients with postvoid residual > 250ml

  • Patients have laboratory abnormalities at screening including:

    1. Aspartate aminotransferase (AST) > 3 x upper limit of normal range
    2. Alanine aminotransferase (ALT) > 3 x upper limit of normal range
    3. Patients have abnormal serum creatinine level > 2 x upper limit of normal range
  • Patients with any other serious disease or condition considered by the investigator not suitable for entry into the trial
  • Patients participated investigational drug trial within 1 month before entering this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678313

Contacts
Contact: Hann-Chorng Kuo, M.D. 886-3-8561825 ext 2113 hck@tzuchi.com.tw
Contact: Dong-Ling Tang, Miss 886-3-8561825 ext 2117 dong_lin86@yahoo.com.tw

Locations
Taiwan
Buddhist Tzu Chi General Hospital Recruiting
Hualien, Taiwan, 970
Contact: Hann-Chorng Kuo, M.D.     886-3-8561825 ext 2113     hck@tzuchi.com.tw    
Contact: Dong-Ling Tang, Miss     886-3-8561825 ext 2117     dong_lin86@yahoo.com.tw    
Principal Investigator: Hann-Chorng Kuo, M.D.            
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Investigators
Principal Investigator: Hann-Chorng Kuo, M.D. Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University
  More Information

Publications:

Responsible Party: Hann-Chorng Kuo, Department of Urology, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT01678313     History of Changes
Other Study ID Numbers: TCGHUROL004
Study First Received: August 29, 2012
Last Updated: March 1, 2013
Health Authority: Taiwan: Department of Health
Taiwan: Research Ethics Committee

Keywords provided by Buddhist Tzu Chi General Hospital:
Benign prostatic hyperplasia (BPH)
Lower urinary tract symptoms (LUTS)
Prostatic specific antigen (PSA)
Cyclooxygenase-2 (COX-2)

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Doxazosin
Celecoxib
Cyclooxygenase 2 Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013