Observation or Radical Treatment in Patients With Prostate Cancer

This study has been terminated.
(Not meeting accrual target.)
Sponsor:
Collaborators:
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
Southwest Oncology Group
Radiation Therapy Oncology Group
Institute of Cancer Research, United Kingdom
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00499174
First received: July 10, 2007
Last updated: November 11, 2013
Last verified: July 2012

July 10, 2007
November 11, 2013
June 2007
December 2011   (final data collection date for primary outcome measure)
Disease-specific survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Disease-specific survival
Complete list of historical versions of study NCT00499174 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Overall survival
  • Quality of life
  • Distant disease-free survival
  • PSA relapse/progression after radical intervention
  • Initiation of androgen deprivation therapy
  • Proportion of patients on the active surveillance arm who receive radical intervention
  • Prognostic significance of PSA doubling-time prior to diagnosis
Not Provided
Not Provided
 
Observation or Radical Treatment in Patients With Prostate Cancer
A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed With Favourable Risk Prostate Cancer [START]

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • 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
  • 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
  • Active Comparator: Radical Intervention
    Radical prostatectomy or radiotherapy based on patient and physician preference
    Interventions:
    • Procedure: conventional surgery
    • Radiation: brachytherapy
    • Radiation: external beam radiation therapy
    • Procedure: Biopsies
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
180
January 2013
December 2011   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00499174
PR11, U10CA077202, CAN-NCIC-CTG-PR11, CALGB-140602, SWOG-PR11, CDR0000557348, RTOG-0873, ECOG-JPR.11, ICR-CTSU-ProSTART
Yes
NCIC Clinical Trials Group
NCIC Clinical Trials Group
  • National Cancer Institute (NCI)
  • Cancer and Leukemia Group B
  • Eastern Cooperative Oncology Group
  • Southwest Oncology Group
  • Radiation Therapy Oncology Group
  • Institute of Cancer Research, United Kingdom
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 The University of Texas Health Science Center at San Antonio
Study Chair: Richard Choo, M.D Mayo Clinic
Study Chair: Chris Parker, M.D Royal Marsden Hospital, Sulton, UK
NCIC Clinical Trials Group
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP