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 Radiation Therapy Oncology Group Breast International Group
Information provided by:	NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:	NCT00499174

Purpose

RATIONALE: Sometimes prostate tumours may not need treatment until they progress. 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 active surveillance is more effective than radical treatment as an initial intervention in favorable prognosis prostate cancer.

PURPOSE: This randomized phase III trial is studying active surveillance 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	Procedure: conventional surgery Procedure: quality-of-life assessment Radiation: brachytherapy Radiation: external beam radiation therapy Procedure: PSA tests Procedure: Biopsies Procedure: Rectal exam	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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 NCIC Clinical Trials Group:

Primary Outcome Measures:

Disease-specific survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Distant disease-free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
PSA relapse/progression after radical intervention [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Initiation of androgen deprivation therapy [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Proportion of patients on the active surveillance arm who receive radical intervention [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Prognostic significance of PSA doubling-time prior to diagnosis [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Prognostic significance of molecular biomarkers [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Enrollment:	180
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Active Surveillance Active surveillance with radical intervention at the time one or more of the following occur: Biochemical progression; Grade progression; Clinical progression	Procedure: quality-of-life assessment frequent quality of life assessments Procedure: PSA tests Frequent PSA tests Procedure: Biopsies Periodic repeat biopsies Procedure: Rectal exam Digital rectal exam
Active Comparator: Radical Intervention Radical prostatectomy or radiotherapy based on patient and physician preference	Procedure: conventional surgery Radical prostatectomy Procedure: quality-of-life assessment frequent quality of life assessments Radiation: brachytherapy high dose rate temporary seed implant; permanent seed implant. Radiation: external beam radiation therapy 3D conformal radiation therapy; intensity modulated radiation therapy.

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 progression 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 radical treatment.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the prostate
- Diagnosed within 6 months prior to 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 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 and TURP), 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

Locations

Canada, British Columbia
Clinical Research Unit at Vancouver Coastal
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, AIB 3V6
Canada, Nova Scotia
QEII Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Ottawa Health Research Institute - General Division
Ottawa, Ontario, Canada, K1H 8L6
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
McGill University - Dept. Oncology
Montreal, Quebec, Canada, H2W 1S6
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
CHUQ-Pavillon Hotel-Dieu de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1

Sponsors and Collaborators

NCIC Clinical Trials Group

National Cancer Institute (NCI)

Cancer and Leukemia Group B

Eastern Cooperative Oncology Group

Southwest Oncology Group

Radiation Therapy Oncology Group

Breast International 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 M. Thompson, MD	University of Texas
Study Chair:	Richard Choo, M.D	Mayo Clinic
Study Chair:	Chris Parker, M.D	Royal Marsden Hospital, Sulton, UK

More Information

No publications provided

Responsible Party:	Ralph M. Meyer, NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:	NCT00499174 History of Changes
Other Study ID Numbers:	PR11, U10CA077202, CAN-NCIC-CTG-PR11, CALGB-140602, SWOG-PR11, CDR0000557348, RTOG-0873, ECOG-JPR.11, ICR-CTSU-ProSTART
Study First Received:	July 10, 2007
Last Updated:	August 8, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by NCIC Clinical Trials Group:

stage II prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 12, 2012