Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer - Full Text View

Sponsor:	American College of Surgeons
Collaborator:	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: conventional surgery Radiation: brachytherapy	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Surgery

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

Hide Study Locations

Locations

United States, Arkansas
St. Vincent Cancer Center
Little Rock, Arkansas, United States, 72205-5499
United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143-0128
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794-9230
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1062
United States, Kansas
Kansas Cancer Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Mexico
Northeast Heights Cancer Center
Albuquerque, New Mexico, United States, 87109
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Wellspan Health - York Cancer Center
York, Pennsylvania, United States, 17403
United States, Tennessee
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States, 78236-5300
United States, Utah
American Fork Hospital
American Fork, Utah, United States, 84003
Dixie Regional Medical Center
Saint George, Utah, United States, 84770
LDS Hospital
Salt Lake City, Utah, United States, 84143
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
United States, Vermont
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, United States, 05401
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States, 23249
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431-5048
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States, 98108
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 355
Canada, Ontario
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6

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 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
Study First Received:	September 13, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00023686 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage II prostate cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009