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

Sponsors and Collaborators:	National Cancer Institute of Canada 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	Procedure: conventional surgery Procedure: observation Procedure: quality-of-life assessment Radiation: brachytherapy Radiation: radiation therapy	Phase III

MedlinePlus related topics: Cancer Prostate Cancer Radiation Therapy

U.S. FDA Resources

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]

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

Show 38 Study Locations

Sponsors and Collaborators

National Cancer Institute of Canada

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	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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:	April 30, 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

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

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 May 07, 2009