Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

PURPOSE: Clinical trial to study the effectiveness of two questionnaires in assessing quality of life of patients who have prostate cancer.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

European Organization for Research and Treatment of Cancer

Neil K. Aaronson

George Van Andel

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00041301
Information obtained from ClinicalTrials.gov on December 19, 2011

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