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.

Condition	Treatment or Intervention
Quality of Life stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer	Procedure: quality-of-life assessment  Procedure: supportive care/therapy

Further Study Details: 

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.

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

Australia, Western Australia
      Sir Charles Gairdner Hospital - Perth, Perth,  Western Australia,  6009,  Australia
Belgium
      Academisch Ziekenhuis der Vrije Universiteit Brussel, Brussels,  1090,  Belgium
      Cazk Groeninghe - Campus Maria's Voorzienigheid, Kortrijk,  B-8500,  Belgium
      Cliniques Universitaires Saint-Luc, Brussels,  1200,  Belgium
      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium
      Universitair Ziekenhuis Gent, Ghent,  B-9000,  Belgium
      Virga Jesse Hospital, Hasselt,  3500,  Belgium
Denmark
      Rigshospitalet, Copenhagen,  2100,  Denmark
France
      Hopital Jean Bernard, Poitiers,  86021,  France
Germany
      Universitaetsklinikum Bonn, Bonn,  D-53105,  Germany
      Universitaets-Krankenhaus Eppendorf, Hamburg,  D-20246,  Germany
Italy
      Azienda Ospedaliera Maggiore Della Carita, Novara,  28100,  Italy
      Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino, Torino,  10126,  Italy
      Istituto Scientifico H. San Raffaele, Milano,  20132,  Italy
      Spedali Civili, Brescia,  25124,  Italy
      Universita di Palermo, Palermo,  90141,  Italy
Netherlands
      Academisch Medisch Centrum, Amsterdam,  1105 AZ,  Netherlands
      Academisch Ziekenhuis Groningen, Groningen,  9713 GZ,  Netherlands
      Daniel Den Hoed Cancer Center at Erasmus Medical Center, Rotterdam,  3008 AE,  Netherlands
      Jeroen Bosch Ziekenhuis, 's-Hertogenbosch,  5211 NL,  Netherlands
      Onze Lieve Vrouwe Gasthuis, Amsterdam,  1091 HA,  Netherlands
      Rijnstate Hospital, ARNHEM,  6800 TA,  Netherlands
      St. Elisabeth Ziekenhuis, Tilburg,  5022 GC,  Netherlands
      University Medical Center Nijmegen, Nijmegen,  NL-6500 HB,  Netherlands
      University Medical Center Rotterdam at Erasmus Medical Center, Rotterdam,  3000 CA,  Netherlands
Norway
      Norwegian Radium Hospital, Oslo,  N-0310,  Norway
Romania
      Inselspital, Bern, Bucarest,  RO 72435,  Romania
      Institute of Oncology - Bucarest, Bucarest,  RO 72435,  Romania
Turkey
      Dokuz Eylul University School of Medicine, Izmir,  35340,  Turkey
      Marmara University Hospital, Istanbul,  81190,  Turkey
United Kingdom, England
      Bristol Haematology and Oncology Centre, Bristol,  England,  BS2 8ED,  United Kingdom
United Kingdom, Wales
      University of Wales College of Medicine, Cardiff,  Wales,  CF14 4XN,  United Kingdom
      Velindre Cancer Center at Velinde Hospital, Cardiff,  Wales,  CF14 2TL,  United Kingdom

Study chairs or principal investigators

Neil K. Aaronson, PhD,  Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital   
George Van Andel, MD,  Onze Lieve Vrouwe Gasthuis   

Study ID Numbers:  CDR0000069463; EORTC-15011; EORTC-30011; NCT00041301
Record last reviewed:  February 2005
Last Updated:  February 8, 2005
Record first received:  July 8, 2002
ClinicalTrials.gov Identifier:  NCT00041301
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08