Observation or Radical Treatment in Patients With Prostate Cancer

NCT ID: NCT00499174

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-06
• Study Completion Date: 2013-01-10

Brief Summary

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.

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Surveillance

Active surveillance with radical intervention at the time one or more of the following occur: Biochemical progression; Grade progression; Clinical progression

Group Type: NO_INTERVENTION

No interventions assigned to this group

Radical Intervention

Radical prostatectomy or radiotherapy based on patient and physician preference

Group Type: ACTIVE_COMPARATOR

conventional surgery

Intervention Type: PROCEDURE

Radical prostatectomy

brachytherapy

Intervention Type: RADIATION

high dose rate temporary seed implant; permanent seed implant.

external beam radiation therapy

Intervention Type: RADIATION

3D conformal radiation therapy; intensity modulated radiation therapy.

Biopsies

Intervention Type: PROCEDURE

Periodic repeat biopsies

Interventions

conventional surgery

Radical prostatectomy

Intervention Type: PROCEDURE

brachytherapy

high dose rate temporary seed implant; permanent seed implant.

Intervention Type: RADIATION

external beam radiation therapy

3D conformal radiation therapy; intensity modulated radiation therapy.

Intervention Type: RADIATION

Biopsies

Periodic repeat biopsies

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Cancer and Leukemia Group B

NETWORK

Sponsor Role: collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role: collaborator

Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role: collaborator

NCIC Clinical Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurence H. Klotz, MD

Role: STUDY_CHAIR

Toronto Sunnybrook Regional Cancer Centre

Adam S. Kibel, MD

Role: STUDY_CHAIR

Washington University Siteman Cancer Center

Martin G. Sanda, MD

Role: STUDY_CHAIR

Beth Israel Deaconess Medical Center

Ian M. Thompson, MD

Role: STUDY_CHAIR

The University of Texas Health Science Center at San Antonio

Richard Choo, M.D

Role: STUDY_CHAIR

Mayo Clinic

Chris Parker, M.D

Role: STUDY_CHAIR

Royal Marsden Hospital, Sulton, UK

Locations

Clinical Research Unit at Vancouver Coastal

Vancouver, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, Canada

QEII Health Sciences Center

Halifax, Nova Scotia, Canada

London Regional Cancer Program

London, Ontario, Canada

Ottawa Health Research Institute - General Division

Ottawa, Ontario, Canada

Odette Cancer Centre

Toronto, Ontario, Canada

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

CHUM - Hopital Notre-Dame

Montreal, Quebec, Canada

McGill University - Dept. Oncology

Montreal, Quebec, Canada

CHUQ-Pavillon Hotel-Dieu de Quebec

Québec, Quebec, Canada

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Countries

Canada

References

Fung-Kee-Fung SD, Porten SP, Meng MV, Kuettel M. The role of active surveillance in the management of prostate cancer. J Natl Compr Canc Netw. 2013 Feb 1;11(2):183-7. doi: 10.6004/jnccn.2013.0026.

Reference Type: DERIVED

PMID: 23411385 (View on PubMed)

Other Identifiers

ICR-CTSU-ProSTART

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA077202

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CAN-NCIC-CTG-PR11

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-140602

Identifier Type: OTHER

Identifier Source: secondary_id

SWOG-PR11

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000557348

Identifier Type: OTHER

Identifier Source: secondary_id

RTOG-0873

Identifier Type: OTHER

Identifier Source: secondary_id

ECOG-JPR.11

Identifier Type: OTHER

Identifier Source: secondary_id

PR11

Identifier Type: -

Identifier Source: org_study_id