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

Prostate Cancer Clinical Trial

Official title:

A Randomized Trial of Radical Prostatectomy Versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00023686
• Other study ID #: ACOSOG-Z0070
• Secondary ID: ACOSOG-Z0070CDR0
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2001
• Last updated: July 1, 2016
• Start date: October 2001
• Est. completion date: April 2004

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 75 Years

Eligibility

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

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:

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• surgery

Radiation:
• radiation

Locations

Country	Name	City	State
Canada	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario
Canada	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario
Canada	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia
United States	Northeast Heights Cancer Center	Albuquerque	New Mexico
United States	American Fork Hospital	American Fork	Utah
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Fletcher Allen Health Care - Medical Center Campus	Burlington	Vermont
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	Kansas Cancer Institute at the University of Kansas Medical Center	Kansas City	Kansas
United States	Wilford Hall Medical Center	Lackland Air Force Base	Texas
United States	St. Vincent Cancer Center	Little Rock	Arkansas
United States	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center	Nashville	Tennessee
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	McKay-Dee Hospital Center	Ogden	Utah
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	Veterans Affairs Medical Center - Richmond	Richmond	Virginia
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Dixie Regional Medical Center	Saint George	Utah
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	LDS Hospital	Salt Lake City	Utah
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	Veterans Affairs Medical Center - Seattle	Seattle	Washington
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	Madigan Army Medical Center	Tacoma	Washington
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	Wellspan Health - York Cancer Center	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (4)

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.

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 Sympo

Crook JM, Gomez-Iturriaga A, Wallace K, Ma C, Fung S, Alibhai S, Jewett M, Fleshner N. Comparison of health-related quality of life 5 years after SPIRIT: Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial. J Clin Oncol. 2011 Feb 1;29( — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		Up to 10 years	No
Secondary	disease free survival		Up to 10 years	No