Observation or Radical Treatment in Patients With Prostate Cancer
This study has been terminated.
(Not meeting accrual target.)
Sponsor:
NCIC Clinical Trials Group
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: January 10, 2013
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Procedure: conventional surgery Radiation: brachytherapy Radiation: external beam radiation therapy Procedure: Biopsies |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed With Favourable Risk Prostate Cancer [START] |
Resource links provided by NLM:
Further study details as provided by NCIC Clinical Trials Group:
Primary Outcome Measures:
- Disease-specific survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 180 |
| Study Start Date: | June 2007 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499174
Locations
| Canada, British Columbia | |
| Clinical Research Unit at Vancouver Coastal | |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, Newfoundland and Labrador | |
| Dr. H. Bliss Murphy Cancer Centre | |
| St. John's, Newfoundland and Labrador, Canada, AIB 3V6 | |
| Canada, Nova Scotia | |
| QEII Health Sciences Center | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| London Regional Cancer Program | |
| London, Ontario, Canada, N6A 4L6 | |
| Ottawa Health Research Institute - General Division | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Univ. Health Network-Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Odette Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| McGill University - Dept. Oncology | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| CHUM - Hopital Notre-Dame | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| CHUQ-Pavillon Hotel-Dieu de Quebec | |
| Quebec City, Quebec, Canada, G1R 2J6 | |
| Centre hospitalier universitaire de Sherbrooke | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
Sponsors and Collaborators
NCIC Clinical Trials Group
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
Southwest Oncology Group
Radiation Therapy Oncology Group
Institute of Cancer Research, United Kingdom
Investigators
| 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 | 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 |
More Information
No publications provided
| Responsible Party: | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00499174 History of Changes |
| Other Study ID Numbers: | PR11, U10CA077202, CAN-NCIC-CTG-PR11, CALGB-140602, SWOG-PR11, CDR0000557348, RTOG-0873, ECOG-JPR.11, ICR-CTSU-ProSTART |
| Study First Received: | July 10, 2007 |
| Last Updated: | January 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NCIC Clinical Trials Group:
|
stage II prostate cancer adenocarcinoma of the prostate |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013