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

• Sponsor: Alliance for Clinical Trials in Oncology (Other)
• Overall Status: Completed
• CT.gov ID: NCT00023686
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 190
• Locations: 36
• Arms: 2
• Duration (Months): 30
• Patients Per Site: 5.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Procedure: surgery; Radiation: radiation	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 190 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Trial of Radical Prostatectomy Versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer
• Study Start Date: Oct 1, 2001
• Actual Primary Completion Date: Apr 1, 2004
• Actual Study Completion Date: Apr 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: surgery Patients undergo radical prostatectomy. Patients are followed every 6 months for 5 years and then annually thereafter.	Procedure: surgery
Experimental: radiation 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

Outcome Measures

Primary Outcome Measures

1. overall survival [Up to 10 years]

Secondary Outcome Measures

1. disease free survival [Up to 10 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 75 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Alliance for Clinical Trials in Oncology
• National Cancer Institute (NCI)

Investigators

• Study Chair: Paul H. Lange, MD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT00023686
• Other Study ID Numbers: ACOSOG-Z0070; ACOSOG-Z0070; CDR0000068851
• First Posted: Jan 27, 2003
• Last Update Posted: Jul 6, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by Alliance for Clinical Trials in Oncology: adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Jul 6, 2016