Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Completed 75 and under NCI ACOSOG-Z0070 ACOSOG-Z0070, NCT00023686

Objectives

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

Entry 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

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

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

Expected Enrollment

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

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.

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, et al.: 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 24 (25): 4158-62, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

American College of Surgeons Oncology Group

Paul Lange, MD, Protocol chair		Ph: 206-543-3918 Email: lange@u.washington.edu

Registry Information
Official Title		A Randomized Trial of Radical Prostatectomy Versus Brachytherapy for Patients with T1c or T2a N0 M0 Prostate Cancer
Trial Start Date		2001-10-10
Trial Completion Date		2004-04-09
Registered in ClinicalTrials.gov		NCT00023686
Date Submitted to PDQ		2001-07-05
Information Last Verified		2003-10-22
NCI Grant/Contract Number		CA76001

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