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AzTrials

Prostate CancerPhase 3NCT00023686

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

A Phase 3 study testing surgery and radiation in people with Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 36 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 75 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
surgery and radiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
36 sitesin 2 countries
Study dates
Oct 2001to Apr 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 75 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

36 sites in 2 countries.

36 sites in 2 countries

United States30 sites

  • Northeast Heights Cancer Center

    Albuquerque, New Mexico, 87109

  • American Fork Hospital

    American Fork, Utah, 84003

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Fletcher Allen Health Care - Medical Center Campus

    Burlington, Vermont, 05401

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1062

  • Kansas Cancer Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236-5300

  • St. Vincent Cancer Center

    Little Rock, Arkansas, 72205-5499

  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

    Nashville, Tennessee, 37232-6838

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Veterans Affairs Medical Center - Richmond

    Richmond, Virginia, 23249

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

    Rochester, New York, 14642

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94143-0128

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington, 98108

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62794-9230

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Dixie Regional Medical Center

    St. George, Utah, 84770

  • Madigan Army Medical Center

    Tacoma, Washington, 98431-5048

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • Walter Reed Army Medical Center

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

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • Wellspan Health - York Cancer Center

    York, Pennsylvania, 17403

Other trials in United States

Canada6 sites

  • Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1R 2J6

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 355

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
surgery, radiation
Keywords
adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • surgeryProcedure or surgery

  • radiationRadiation

Study groups in NCT00023686
Study groupRoleWhat they receive
surgeryExperimentalPatients undergo radical prostatectomy. Patients are followed every 6 months for 5 years and then annually thereafter.
Receives: Procedure: surgery
radiationExperimentalPatients 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.
Receives: Radiation: radiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    Measured: Up to 10 years

Secondary outcomes (1)

  1. disease free survival

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startOct 2001
  3. Primary completionApr 2004
  4. Study completionApr 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00023686
Sponsor's protocol ID
ACOSOG-Z0070
Other IDs
ACOSOG-Z0070, CDR0000068851
Status last verified
Jul 2016
First submitted
13 Sep 2001
Last updated
6 Jul 2016
Results posted
No
Data monitoring committee
No

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. doi: 10.1200/JCO.2006.06.3875.

    PubMed 16943531

  • 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.

    PubMed 21149658

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing surgery and radiation in people with Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 36 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00023686, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.

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