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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 13, 2001

Last Updated Date

February 6, 2009

Start Date ^†

October 2001

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00023686 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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.

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Active Control

Condition ^†

Prostate Cancer

Intervention ^†

Procedure: conventional surgery
Radiation: brachytherapy

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

April 2004 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Male

Ages

up to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Canada

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00023686

Responsible Party

Secondary IDs ^††

ACOSOG-Z0070

Study Sponsor ^†

American College of Surgeons

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Study Chair:

Paul H. Lange, MD

University of Washington

Information Provided By

National Cancer Institute (NCI)

Verification Date

October 2003

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.