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Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer

This study has been completed.

Sponsors and Collaborators: American College of Surgeons
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00023686
  Purpose

RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether surgery is more effective than internal radiation in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with that of internal radiation in treating patients who have stage II prostate cancer.


Condition Intervention Phase
Prostate Cancer
Procedure: brachytherapy
Procedure: conventional surgery
Phase III

MedlinePlus related topics:   Cancer    Prostate Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Active Control
Official Title:   A Randomized Trial of Radical Prostatectomy Versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   October 2001
Primary Completion Date:   April 2004 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

  • Compare overall survival in patients with stage II prostate cancer treated with radical prostatectomy vs brachytherapy.
  • Compare metastasis-free survival and probability of survival without symptoms of patients treated with these regimens.
  • Compare the side effects of these treatment regimens in these patients.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.

  • Arm I: Patients undergo radical prostatectomy.
  • Arm II: Patients undergo brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,980 patients (990 per treatment arm) will be accrued for this study within 5.5 years.

  Eligibility
Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate within the past 120 days

    • T1c-T2a, N0, M0
  • No bilateral disease
  • Prostate-specific antigen (PSA) no greater than 10 ng/mL

    • In patients with prior neoadjuvant hormonal therapy (NHT), PSA must be less than 10 ng/mL prior to therapy
  • Gleason score no greater than 6
  • Prostate gland less than 60 cc on transrectal ultrasound or with minimal pubic arch interference OR
  • Prostate gland 60 cc or greater prior to NHT allowed if prostate size has been reduced to less than 60 cc by NHT

PATIENT CHARACTERISTICS:

Age:

  • 75 and under

Performance status:

  • ECOG 0-2 OR
  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Creatinine no greater than 3 mg/dL

Cardiovascular:

  • No significant cardiovascular disease
  • No New York Heart Association class III or IV heart disease

Other:

  • No other malignancy within the past 5 years except effectively treated basal cell or squamous cell skin cancer or other malignancy at low risk for recurrence
  • No other condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • See Disease Characteristics
  • At least 90 days since prior NHT

    • Duration of therapy no greater than 120 days
  • No concurrent NHT

Radiotherapy:

  • No prior radiotherapy to pelvis

Surgery:

  • No prior surgery for prostate cancer or benign disease, including:

    • Transurethral resection of the prostate
    • Transurethral resection of the bladder neck
    • Cryotherapy
    • Laser ablation
    • Microwave therapy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023686

Show 36 study locations  Show 36 Study Locations

Sponsors and Collaborators
American College of Surgeons
National Cancer Institute (NCI)

Investigators
Study Chair:     Paul H. Lange, MD     University of Washington    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications:
Crook J, Wallace K, Jewett M, et al.: Enhancing enrollment in difficult randomized trials: the profile of men accepting randomization to SPIRIT (surgical prostatectomy vs interstitial radiation). [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-295, 2006.
 
Wallace K, Fleshner N, Jewett M, Basiuk J, Crook J. Impact of a multi-disciplinary patient education session on accrual to a difficult clinical trial: the Toronto experience with the surgical prostatectomy versus interstitial radiation intervention trial. J Clin Oncol. 2006 Sep 1;24(25):4158-62.
 

Study ID Numbers:   CDR0000068851, ACOSOG-Z0070
First Received:   September 13, 2001
Last Updated:   August 29, 2008
ClinicalTrials.gov Identifier:   NCT00023686
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate  
stage II prostate cancer  

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2008




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