Clinical trial NCT00499174: Observation or Radical Treatment in Patients With Prostate Cancer
Official title: A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed With Favourable Risk Prostate Cancer [START]
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: stage II prostate cancer
adenocarcinoma of the prostate
Lead sponsor: Canadian Cancer Trials Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: Cancer and Leukemia Group B
name: Eastern Cooperative Oncology Group
name: SWOG Cancer Research Network
name: Radiation Therapy Oncology Group
name: Institute of Cancer Research, United Kingdom
First posted: 2007-07-11
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Disease-specific Survival
timeFrame: 5 years 6 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 5 years 6 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Clinical Research Unit at Vancouver Coastal
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: St. John's
country: Canada
facility: Dr. H. Bliss Murphy Cancer Centre
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: QEII Health Sciences Center
state: Nova Scotia
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Health Research Institute - General Division
state: Ontario
city: Toronto
country: Canada
facility: Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Univ. Health Network-Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: CHUM - Hopital Notre-Dame
state: Quebec
city: Montreal
country: Canada
facility: McGill University - Dept. Oncology
state: Quebec
city: Quebec City
country: Canada
facility: CHUQ-Pavillon Hotel-Dieu de Quebec
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
Study officials:
affiliation: Toronto Sunnybrook Regional Cancer Centre
name: Laurence H. Klotz, MD
role: STUDY_CHAIR
affiliation: Washington University Siteman Cancer Center
name: Adam S. Kibel, MD
role: STUDY_CHAIR
affiliation: Beth Israel Deaconess Medical Center
name: Martin G. Sanda, MD
role: STUDY_CHAIR
affiliation: The University of Texas Health Science Center at San Antonio
name: Ian M. Thompson, MD
role: STUDY_CHAIR
affiliation: Mayo Clinic
name: Richard Choo, M.D
role: STUDY_CHAIR
affiliation: Royal Marsden Hospital, Sulton, UK
name: Chris Parker, M.D
role: STUDY_CHAIR
References:
citation: 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.