Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Assessing Quality of Life of Patients With Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Natural history/Epidemiology Closed Any age Other EORTC-15011 EORTC-30011, NCT00041301

Objectives

1. Assess the scale structure, psychometric validity, and reliability of quality of life measurements using the EORTC QLQ-C30 and the prostate cancer-specific QLQ-PR25 questionnaires in patients with stage I-IV prostate cancer.

Entry Criteria

Disease Characteristics:

• Histologically confirmed prostate cancer



• Stratum I:
  • Clinically localized primary prostate cancer
    • T1-T3, G1-G3, N0, M0
    • Plan to undergo a radical prostatectomy

    OR

  • Local or locally advanced primary prostate cancer
    • T1-T4, G1-G3, N0, M0
    • Plan to undergo radiotherapy with curative intent



• Stratum II:
  • Metastatic prostate cancer
    • T1-T4, G1-G3, N1, M0-M1

      OR

    • T1-T4, G1-G3, N0-1, M1
    • Plan to receive hormonal treatment
      • No anti-androgen monotherapy



• No cerebral metastases

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• See Disease Characteristics
• No prior neoadjuvant hormonal treatment
• Planned adjuvant hormonal therapy (orchiectomy, luteinizing hormone-releasing hormone analogue, or maximal androgen blockade) is allowed for patients in stratum I

Radiotherapy:

• See Disease Characteristics
• No interstitial radiotherapy
• More than 2 years since prior radiotherapy (stratum II)

Surgery:

• See Disease Characteristics
• More than 2 years since prior prostatectomy (stratum II)

Other:

• No prior treatment for prostate carcinoma

Patient Characteristics:

Age:

• Any age

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Mentally fit to complete a questionnaire
• Literate in the language of the questionnaires
• No psychological, familial, sociological, or geographical condition that would preclude compliance
• No other concurrent malignancy except basal cell skin cancer
• No concurrent participation in other quality of life investigations that would preclude study participation

Expected Enrollment

A total of 375 patients will be accrued for this study.

Outline

This is a multicenter study. Patients are stratified according to stage of disease (local or locally advanced disease vs metastatic disease).

Patients complete EORTC QLQ-C30 and prostate cancer-specific QLQ-PR25 questionnaires before therapy and at 3 months after the start of therapy. Patients in stratum II also complete questionnaires at 6 months after the start of therapy.

Arraras Urdaniz JI, Villafranca Iturre E, Arias de la Vega F, et al.: The eortc quality of life questionnaire QLQ-C30 (version 3.0). Validation study for Spanish prostate cancer patients. Arch Esp Urol 61 (8): 949-54, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Neil Aaronson, PhD, Study coordinator		Ph: 31-20-512-2481
George Van Andel, MD, Study coordinator		Ph: 31-20-599-3054

Registry Information
Official Title		An International Field Study Of The Reliability And Validity Of The EORTC QLQ-C30 And A Disease-Specific Questionnaire Module (QLQ-PR25) For Assessing Quality Of Life Of Patients With Prostate Cancer
Trial Start Date		2002-03-21
Registered in ClinicalTrials.gov		NCT00041301
Date Submitted to PDQ		2002-05-30
Information Last Verified		2004-12-02

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