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

Show 36 Study Locations

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 09, 2009