NCT00023686

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P25-P50 for phase_3 prostate-cancer

Timeline
Completed

Started Oct 2001

Shorter than P25 for phase_3 prostate-cancer

Geographic Reach
2 countries

36 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2001

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2001

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

2.5 years

First QC Date

September 13, 2001

Last Update Submit

July 1, 2016

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage IIB prostate cancerstage IIA prostate cancer

Outcome Measures

Primary Outcomes (1)

  • overall survival

    Up to 10 years

Secondary Outcomes (1)

  • disease free survival

    Up to 10 years

Study Arms (2)

surgery

EXPERIMENTAL

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

Procedure: surgery

radiation

EXPERIMENTAL

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

Interventions

surgeryPROCEDURE
surgery
radiationRADIATION
radiation

Eligibility Criteria

AgeUp to 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (36)

St. Vincent Cancer Center

Little Rock, Arkansas, 72205-5499, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94143-0128, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62794-9230, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1062, United States

Location

Kansas Cancer Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Northeast Heights Cancer Center

Albuquerque, New Mexico, 87109, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Wellspan Health - York Cancer Center

York, Pennsylvania, 17403, United States

Location

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, 37232-6838, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236-5300, United States

Location

American Fork Hospital

American Fork, Utah, 84003, United States

Location

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Regional Medical Center

St. George, Utah, 84770, United States

Location

Fletcher Allen Health Care - Medical Center Campus

Burlington, Vermont, 05401, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Veterans Affairs Medical Center - Richmond

Richmond, Virginia, 23249, United States

Location

Veterans Affairs Medical Center - Seattle

Seattle, Washington, 98108, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431-5048, United States

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 355, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Related 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.

    BACKGROUND

  • 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. doi: 10.1200/JCO.2006.06.3875.

    PMID: 16943531BACKGROUND

  • 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(4):362-8. doi: 10.1200/JCO.2010.31.7305. Epub 2010 Dec 13.

    PMID: 21149658RESULT

  • 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.

    RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Surgical Procedures, OperativeRadiation

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Paul H. Lange, MD

    University of Washington

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2001

First Posted

January 27, 2003

Study Start

October 1, 2001

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

July 6, 2016

Record last verified: 2016-07

Locations

US(30)CA(6)