Observation or Radical Treatment in Patients With Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00499174|
Recruitment Status : Terminated (Not meeting accrual target.)
First Posted : July 11, 2007
Results First Posted : May 12, 2021
Last Update Posted : May 12, 2021
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
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 or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: conventional surgery Radiation: brachytherapy Radiation: external beam radiation therapy Procedure: Biopsies||Not Applicable|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed With Favourable Risk Prostate Cancer [START]|
|Actual Study Start Date :||June 15, 2007|
|Actual Primary Completion Date :||December 31, 2011|
|Actual Study Completion Date :||January 10, 2013|
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
high dose rate temporary seed implant; permanent seed implant.
Radiation: external beam radiation therapy
3D conformal radiation therapy; intensity modulated radiation therapy.
Periodic repeat biopsies
- Disease-specific Survival [ Time Frame: 5 years 6 months ]Time from the date of randomization to the date of death due to prostate cancer.
- Overall Survival [ Time Frame: 5 years 6 months ]Time from randomization to the date of death due to any causes.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499174
|Canada, British Columbia|
|Clinical Research Unit at Vancouver Coastal|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|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|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Health Research Institute - General Division|
|Ottawa, Ontario, Canada, K1H 8L6|
|Odette Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Univ. Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|CHUM - Hopital Notre-Dame|
|Montreal, Quebec, Canada, H2L 4M1|
|McGill University - Dept. Oncology|
|Montreal, Quebec, Canada, H2W 1S6|
|CHUQ-Pavillon Hotel-Dieu de Quebec|
|Quebec City, Quebec, Canada, G1R 2J6|
|Centre hospitalier universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Allan Blair Cancer Centre|
|Regina, Saskatchewan, Canada, S4T 7T1|
|Study Chair:||Laurence H. Klotz, MD||Toronto Sunnybrook Regional Cancer Centre|
|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|
|Responsible Party:||NCIC Clinical Trials Group|
|Other Study ID Numbers:||
U10CA077202 ( U.S. NIH Grant/Contract )
CAN-NCIC-CTG-PR11 ( Registry Identifier: PDQ )
CALGB-140602 ( Other Identifier: CALGB Assigned Trial Code )
SWOG-PR11 ( Other Identifier: SWOG Assigned Trial Code )
CDR0000557348 ( Other Identifier: PDQ )
RTOG-0873 ( Other Identifier: RTOG )
ECOG-JPR.11 ( Other Identifier: ECOG Assigned Trial Code )
ICR-CTSU-ProSTART ( Other Identifier: CTSU )
|First Posted:||July 11, 2007 Key Record Dates|
|Results First Posted:||May 12, 2021|
|Last Update Posted:||May 12, 2021|
|Last Verified:||May 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
stage II prostate cancer
adenocarcinoma of the prostate
Genital Neoplasms, Male
Neoplasms by Site