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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00023686
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 6, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Procedure: surgery Radiation: radiation Phase 3

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Radical Prostatectomy Versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer
Study Start Date : October 2001
Actual Primary Completion Date : April 2004
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: surgery

Patients undergo radical prostatectomy.

Patients are followed every 6 months for 5 years and then annually thereafter.

Procedure: surgery
Experimental: radiation

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.

Radiation: radiation

Primary Outcome Measures :
  1. overall survival [ Time Frame: Up to 10 years ]

Secondary Outcome Measures :
  1. disease free survival [ Time Frame: Up to 10 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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



  • 75 and under

Performance status:

  • ECOG 0-2 OR
  • Zubrod 0-2


  • Creatinine no greater than 3 mg/dL


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


  • 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


Endocrine therapy:

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

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


  • No prior radiotherapy to pelvis


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00023686

  Show 36 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Paul H. Lange, MD University of Washington

Publications of Results:
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.

Other 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.

Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00023686     History of Changes
Other Study ID Numbers: ACOSOG-Z0070
CDR0000068851 ( Registry Identifier: NCI Physician Data Query )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
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
Genital Diseases, Male
Prostatic Diseases