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

This study has been completed.
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: July 2, 2014
Last verified: July 2014
  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. Doxazosin 4 mg daily plus celecoxib 200 mg every day (QD)
  2. Doxazosin 4mg every day (QD)

Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
Drug: Doxazosin 4 mg every day (QD)
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:


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 and 3 months after initial treatment ] [ Designated as safety issue: No ]

    Efficacy:

    Change from Baseline in the serum PSA level from baseline and 3 months Change = Month 3 minus Baseline value



Secondary Outcome Measures:
  • Change From Baseline in the Void Volume (VV) [ Time Frame: Baseline and 3 months after initial treatment ] [ Designated as safety issue: No ]

    Efficacy:

    Change from Baseline in the Void Volume (VV) from baseline and 3 months Change = Month 3 minus Baseline value


  • Change From Baseline in the Maximum Flow Rate (Qmax) [ Time Frame: Baseline and 3 months after initial treatment ] [ Designated as safety issue: No ]

    Efficacy:

    Change from Baseline in the maximum flow rate (Qmax) from baseline and 3 months Change = Month 3 minus Baseline value


  • Change From Baseline in the IPSS Subscore (IPSS Voiding) Questionnaires [ Time Frame: Baseline and 3 months after initial treatment ] [ Designated as safety issue: No ]

    Efficacy:

    Change from Baseline in the IPSS Voiding from baseline and 3 months. The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always". Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.

    The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).

    Change = Month 3 minus Baseline value


  • Change From Baseline in the IPSS Subscore (IPSS Storage) Questionnaires [ Time Frame: Baseline and 3 months after initial treatment ] [ Designated as safety issue: No ]

    Efficacy:

    Change from Baseline in the IPSS Storage from baseline and 3 months The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always". Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.

    The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).

    Change = Month 3 minus Baseline value


  • Change From Baseline in the International Prostate Symptom Score (IPSS) Questionnaires [ Time Frame: Baseline and 3 months after initial treatment ] [ Designated as safety issue: No ]

    Efficacy:

    Change from Baseline in the International Prostate Symptom Score (IPSS) from baseline and 3 months The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS Voiding), 3 storage questions (IPSS Storage) The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always".

    Total IPSS score = IPSS voiding + IPSS Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35

    Change = Month 3 minus Baseline value



Enrollment: 140
Study Start Date: August 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study group
Doxazosin 4 mg daily plus celecoxib 200 mg every day (QD)
Drug: Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
Study group
Other Names:
  • Doxazosin 4 mg
  • Celecoxib 200 mg
Experimental: Control group
Doxazosin 4 mg every day (QD)
Drug: Doxazosin 4 mg every day (QD)
Control group
Other Name: Doxazosin 4 mg

  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 > 250 mL
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678313

Locations
Taiwan
Buddhist Tzu Chi General Hospital
Hualien, Taiwan, 970
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
Results First Received: April 8, 2014
Last Updated: July 2, 2014
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 July 29, 2014