Observation or Radical Treatment in Patients With Prostate Cancer

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.

Conditions

• Prostate Cancer

Interventions

PROCEDURE

conventional surgery

Radical prostatectomy

RADIATION

brachytherapy

high dose rate temporary seed implant; permanent seed implant.

RADIATION

external beam radiation therapy

3D conformal radiation therapy; intensity modulated radiation therapy.

PROCEDURE

Biopsies

Periodic repeat biopsies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Cancer and Leukemia Group B

  collaborator NETWORK

• Eastern Cooperative Oncology Group

  collaborator NETWORK

• SWOG Cancer Research Network

  collaborator NETWORK

• Radiation Therapy Oncology Group

  collaborator NETWORK

• Institute of Cancer Research, United Kingdom

  collaborator OTHER

• NCIC Clinical Trials Group

  lead NETWORK

Principal Investigators

• Laurence H. Klotz, MD · Toronto Sunnybrook Regional Cancer Centre

• Adam S. Kibel, MD · Washington University Siteman Cancer Center

• Martin G. Sanda, MD · Beth Israel Deaconess Medical Center

• Ian M. Thompson, MD · The University of Texas Health Science Center at San Antonio

• Richard Choo, M.D · Mayo Clinic

• Chris Parker, M.D · Royal Marsden Hospital, Sulton, UK

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-12-06

Primary Completion

2011-12-31

Completion

2013-01-10

Countries

• Canada

Study Locations