Observation or Radical Treatment in Patients With Prostate Cancer - Full Text View

Sponsor:	NCIC Clinical Trials Group
Collaborators:	National Cancer Institute (NCI) Cancer and Leukemia Group B Eastern Cooperative Oncology Group Southwest Oncology Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00499174

Purpose

RATIONALE: Sometimes the tumor may not need treatment until it progresses. In this case, observation may be sufficient. Radical treatments, such as radical prostatectomy or radiation therapy, may be effective in treating prostate cancer when it is first diagnosed. It is not yet known whether observation is more effective than radical treatment as an initial intervention in favorable prognosis prostate cancer.

PURPOSE: This randomized phase III trial is studying observation to see how well it works compared with radical treatment as an initial intervention in patients with favorable prognosis prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Other: active surveillance Procedure: conventional surgery Procedure: quality-of-life assessment Radiation: brachytherapy Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized
Official Title:	A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed With Favourable Risk Prostate Cancer [START]

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-specific survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Quality of life [ Designated as safety issue: No ]
Distant disease-free survival [ Designated as safety issue: No ]
PSA relapse/progression after radical intervention [ Designated as safety issue: No ]
Initiation of androgen deprivation therapy [ Designated as safety issue: No ]
Proportion of patients on the active surveillance arm who receive radical intervention [ Designated as safety issue: No ]
Prognostic significance of PSA doubling-time prior to diagnosis [ Designated as safety issue: No ]
Prognostic significance of molecular biomarkers [ Designated as safety issue: No ]

Estimated Enrollment:	2130
Study Start Date:	June 2007
Estimated Primary Completion Date:	April 2023 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To compare disease-specific survival of patients with favorable risk prostate cancer treated with radical prostatectomy or radical radiotherapy at the time of initial diagnosis vs active surveillance and selective intervention based on pre-specified biochemical, histological, or clinical criteria.

Secondary

To compare overall survival, quality of life using the EPIC-26, RAND SF-12, and State-Trait Anxiety Inventory, distant disease-free survival, PSA relapse/progression after radical intervention, and initiation of androgen deprivation therapy between the two treatment arms.
To determine the proportion of patients on the active surveillance arm who receive radical intervention for prostate cancer.
To determine if PSA doubling-time prior to diagnosis predicts eventual outcome.
To determine if molecular biomarkers predict outcome.

OUTLINE: This is a prospective, randomized, multicenter study. Patients are stratified by treatment center, ECOG performance status (0 vs 1 or 2), disease stage (T1 vs T2), baseline PSA value (ng/mL or μg/L) (< 5.0 vs ≥ 5.0 and ≤ 10.0), and age (< 65 years vs ≥ 65 years). Patients are randomized to 1 of 2 arms.

Arm I: Patients undergo radical intervention (radical prostatectomy or radiotherapy [external-beam radiotherapy 5 days a week for 4-8 weeks; permanent prostate brachytherapy; or high-dose rate temporary brachytherapy], based on patient and physician preference).
Arm II: Patients undergo active surveillance with radical intervention at the time one or more pre-specified criteria (biochemical progression, histologic/grade progression, and/or clinical progression) are met.

Quality of life is assessed by the EPIC-26, RAND SF-12, and State Anxiety Inventory at baseline, periodically during study treatment, and after completion of study treatment.

After completion of study treatment, patients are followed every 6 months.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the prostate
- Diagnosed within 6 months prior to study randomization
Patient has been classified as favorable risk as defined by the following:
- Clinical stage T1b, T1c, T2a, or T2b at the time of diagnosis
- Clinical (diagnostic biopsy) Gleason score ≤ 6
- PSA ≤ 10.0 ng/mL
Physical examination, rectal examination, and transrectal ultrasound have been done within 6 months prior to study randomization and radiographic studies, if indicated, are negative for metastasis
Patient is a suitable candidate for radical prostatectomy or radiotherapy

PATIENT CHARACTERISTICS:

ECOG performance status 0, 1, or 2
Patient has a minimum life expectancy of > 10 years
In centers participating in the quality of life component of the study, the patient is able (i.e., sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French
No history of other malignancies, except adequately treated non-melanoma skin cancer, adequately treated superficial bladder cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years from study randomization

PRIOR CONCURRENT THERAPY:

No previous treatment for prostate cancer, including surgery (excluding biopsy), radiotherapy, or androgen deprivation therapy for greater than 3 months
No planned androgen therapy except in the context of radical therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499174

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Locations

United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center	Recruiting
Aurora, Colorado, United States, 80045
Contact: Clinical Trials Office - University of Colorado Cancer Center 720-848-0650
United States, Illinois
University of Chicago Cancer Research Center	Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424
United States, Michigan
William Beaumont Hospital - Royal Oak Campus	Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Clinical Trials Office - William Beaumont Hospital - Royal Oak 248-551-7695
United States, Minnesota
Mayo Clinic Cancer Center	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Adam S. Kibel, MD 314-362-8295
United States, New Hampshire
Kingsbury Center for Cancer Care at Cheshire Medical Center	Recruiting
Keene, New Hampshire, United States, 03431
Contact: Alan C. Hartford, MD, PhD 603-650-6600
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Recruiting
Lebanon, New Hampshire, United States, 03756-0002
Contact: Clinical Trials Office - Norris Cotton Cancer Center 603-650-7609 cancerhelp@dartmouth.edu
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675
United States, New York
Roswell Park Cancer Institute	Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724
United States, North Carolina
Duke Comprehensive Cancer Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853
United States, Oklahoma
Oklahoma University Cancer Institute	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Terence S. Herman 405-271-6822
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi 215-728-4790
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19107-5541
Contact: Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer 215-955-6084
United States, Texas
Brooke Army Medical Center	Recruiting
Fort Sam Houston, Texas, United States, 78234-6200
Contact: Clinical Trials Office - Brooke Army Medical Center 210-916-4837
University of Texas Health Science Center at San Antonio	Recruiting
San Antonio, Texas, United States, 78229-3900
Contact: Joseph W. Basler 210-567-4777
Wilford Hall Medical Center	Recruiting
Lackland AFB, Texas, United States, 78236
Contact: Douglas A. Nelson, MD 228-377-6588
United States, Vermont
Norris Cotton Cancer Center - North	Recruiting
Saint Johnsbury, Vermont, United States, 05819
Contact: Alan C. Hartford, MD, PhD 603-650-6600
United States, Wisconsin
Medical College of Wisconsin Cancer Center	Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C 414-805-4380
Veterans Affairs Medical Center - Milwaukee	Recruiting
Milwaukee, Wisconsin, United States, 53295
Contact: Elizabeth M. Gore, MD 414-805-4465
Canada, British Columbia
University of British Columbia	Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Martin E. Gleave 604-875-4111
Canada, Manitoba
CancerCare Manitoba	Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Darrel E. Drachenberg 204-787-4468
Canada, Nova Scotia
Nova Scotia Cancer Centre	Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Ricardo A. Rendon 902-473-6570
Canada, Ontario
Edmond Odette Cancer Centre at Sunnybrook	Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Laurence Klotz 416-480-4673
London Regional Cancer Program at London Health Sciences Centre	Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Joseph Chin 519-685-8451
Ottawa Hospital Regional Cancer Centre - General Campus	Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Christopher Morash 613-761-4500
Princess Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Peter Chung 416-946-4501
Canada, Quebec
McGill Cancer Centre at McGill University	Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: Sergio Luiz Faria 514-934-8040
CHUS-Hopital Fleurimont	Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Abdenour Nabid 819-346-1110
Centre Hospitalier Universitaire de Quebec	Recruiting
Quebec City, Quebec, Canada, G1R 2J6
Contact: Louis Lacombe 418-691-5O50

Sponsors and Collaborators

NCIC Clinical Trials Group

National Cancer Institute (NCI)

Cancer and Leukemia Group B

Eastern Cooperative Oncology Group

Southwest Oncology Group

Investigators

Study Chair:	Laurence H. Klotz, MD	Edmond Odette Cancer Centre at Sunnybrook
Study Chair:	Adam S. Kibel, MD	Washington University Siteman Cancer Center
Study Chair:	Martin G. Sanda, MD	Beth Israel Deaconess Medical Center
Study Chair:	Ian L. Thompson, MD	St. Joseph Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Cancer Research Institute at Queen's University ( Ralph M. Meyer )
Study ID Numbers:	CDR0000557348, CAN-NCIC-CTG-PR11, CALGB-140602, SWOG-PR11
Study First Received:	July 10, 2007
Last Updated:	December 23, 2009
ClinicalTrials.gov Identifier:	NCT00499174 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage II prostate cancer
adenocarcinoma of the prostate

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 December 23, 2009