Know Cancer

or
forgot password

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


N/A
N/A
75 Years
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

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

Radiotherapy

- See Disease Characteristics

Surgery

- See Disease Characteristics

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Martin G. Sanda, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000258478

NCT ID:

NCT00052481

Start Date:

September 2002

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Washington University School of MedicineSaint Louis, Missouri  63110
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Madigan Army Medical CenterTacoma, Washington  98431-5048
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Fletcher Allen Health Care - Medical Center CampusBurlington, Vermont  05401
Sentara Norfolk General HospitalNorfolk, Virginia  23507
Presbyterian HospitalCharlotte, North Carolina  28233-3549