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NCT Number: NCT00052481

Quality of Life in Patients Undergoing Surgery or Brachytherapy for Stage II Prostate Cancer

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

PURPOSE: Randomized clinical trial to study quality of life in patients undergoing radical prostatectomy or brachytherapy for stage II prostate cancer.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

Up to 75 year

Sex eligibility

Male

Study type

Observational

Primary location

UCSF Comprehensive Cancer Center, San Francisco, California, United States

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About this study

OBJECTIVES:

  • Compare changes in health-related quality of life (HRQOL) in patients with stage II prostate cancer up to 2 years after treatment with radical prostatectomy or brachytherapy.
  • Compare the effect of baseline HRQOL, age, and other covariates on HRQOL improvement or deterioration in these patients up to 10 years after these treatments.
  • Compare the effect of treatment modality on HRQOL improvement or deterioration in these patients up to 10 years after these treatments.
  • Compare the effects of treatment failure on HRQOL, in terms of disease progression, in these patients.

OUTLINE: Patients are randomized to 1 of 2 arms on ACOSOG-Z0070 (radical prostatectomy vs brachytherapy).

Patients in both arms complete a quality of life questionnaire at baseline, 2 and 6 months after treatment, and then at 1, 2, 4, 7, and 10 years after treatment.

PROJECTED ACCRUAL: A total of 500 patients (250 per group) will be accrued for this study within 2 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate within the past 120 days
  • Stage II disease (T1c-T2a, N0, M0)
  • Concurrent enrollment on ACOSOG-Z0070
  • Not yet randomized to an intervention arm (radical prostatectomy or brachytherapy)
  • Willing and able to complete heath-related quality of life questionnaires

PATIENT CHARACTERISTICS:

Age

  • 75 and under

PRIOR CONCURRENT THERAPY:

Endocrine therapy

  • More than 6 months since prior hormonal therapy for prostate cancer

Treatment and study plan

quality-of-life assessment

Procedure

Primary outcomes

  1. time to treatment failure

    Time frame: Up to 10 years

Secondary outcomes

  1. disease progression

    Time frame: Up to 10 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Health-Related Quality Of Life In Patients With Low Risk, Localized Prostate Cancer Randomized To Radical Prostatectomy Or Brachytherapy

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Jan 27, 2003
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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