Assessing Quality of Life of Patients With Prostate Cancer

RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may help determine the intermediate and long-term effects of the treatment on these patients.

Official Title

Study of the EORTC QLQ-C30 and Prostate Cancer-Specific QLQ-PR25 Questionnaires to Assess Quality of Life of Patients With Stage I-IV Prostate Cancer

Conditions

– Quality of Life- stage I prostate cancer- stage II prostate cancer- stage III prostate cancer- stage IV prostate cancer

Study Type

Interventional

Study Design

Treatment

Further Details

PURPOSE: Clinical trial to study the effectiveness of two questionnaires in assessing quality of life of patients who have prostate cancer. OBJECTIVES: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. 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. PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.

Study Start

Eligibility & Criteria

Genders Eligible for Study: Both 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 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 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

Total Enrolment

Contact Details

[1] EORTC Quality of Life Study Group[2] EORTC Genito-Urinary Tract Cancer Cooperative Group[3] Sir Charles Gairdner Hospital – Perth, Perth, Western Australia, 6009