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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00023686
First received: September 13, 2001
Last updated: July 7, 2011
Last verified: October 2003
History of Changes
  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: conventional surgery
Radiation: brachytherapy
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

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
Sponsors and Collaborators
American College of Surgeons
National Cancer Institute (NCI)
Investigators
Study Chair: Paul H. Lange, MD University of Washington
  More Information

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

Publications:
Crook JM, Gomez-Iturriaga A, Wallace K, et al.: Comparison of health-related quality of life 5 years after SPIRIT (Surgical Prostatectomy [RP] versus Interstitial Radiation [BT] Intervention trial ACOSOG Z0070). [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-11, 2010.
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.

ClinicalTrials.gov Identifier: NCT00023686     History of Changes
Other Study ID Numbers: CDR0000068851, ACOSOG-Z0070
Study First Received: September 13, 2001
Last Updated: July 7, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013