Prostate CancerNCT00499174
Observation or Radical Treatment in Patients With Prostate Cancer
A study testing conventional surgery, brachytherapy and external beam radiation therapy in people with Prostate Cancer, run by NCIC Clinical Trials Group at 13 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- conventional surgery, brachytherapy and external beam radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 13 sitesCanada
- Study dates
- 6 Dec 2007to 10 Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Canada13 sites
QEII Health Sciences Center
Halifax, Nova Scotia, B3H 1V7
London Regional Cancer Program
London, Ontario, N6A 4L6
CHUM - Hopital Notre-Dame
Montreal, Quebec, H2L 4M1
McGill University - Dept. Oncology
Montreal, Quebec, H2W 1S6
Ottawa Health Research Institute - General Division
Ottawa, Ontario, K1H 8L6
CHUQ-Pavillon Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, AIB 3V6
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Clinical Research Unit at Vancouver Coastal
Vancouver, British Columbia, V5Z 1M9
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- conventional surgery, brachytherapy, external beam radiation therapy, Biopsies
- Keywords
- stage II prostate cancer, adenocarcinoma of the prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional surgeryProcedure or surgery
Radical prostatectomy
brachytherapyRadiation
high dose rate temporary seed implant; permanent seed implant.
external beam radiation therapyRadiation
3D conformal radiation therapy; intensity modulated radiation therapy.
BiopsiesProcedure or surgery
Periodic repeat biopsies
| Study group | Role | What they receive |
|---|---|---|
| Active Surveillance | No intervention | Active surveillance with radical intervention at the time one or more of the following occur: Biochemical progression; Grade progression; Clinical progression |
| Radical Intervention | Active comparator | Radical prostatectomy or radiotherapy based on patient and physician preference Receives: Procedure: conventional surgery; Radiation: brachytherapy; Radiation: external beam radiation therapy; Procedure: Biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-specific Survival
Time from the date of randomization to the date of death due to prostate cancer.
Measured: 5 years 6 months
Secondary outcomes (1)
Overall Survival
Time from randomization to the date of death due to any causes.
Measured: 5 years 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study start6 Dec 2007
- Primary completion31 Dec 2011
- Study completion10 Jan 2013
Why it stopped: Not meeting accrual target.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, SWOG Cancer Research Network, Radiation Therapy Oncology Group, Institute of Cancer Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Laurence H. Klotz, MD, Study chair, Toronto Sunnybrook Regional Cancer CentreAdam S. Kibel, MD, Study chair, Washington University Siteman Cancer CenterMartin G. Sanda, MD, Study chair, Beth Israel Deaconess Medical CenterIan M. Thompson, MD, Study chair, The University of Texas Health Science Center at San AntonioRichard Choo, M.D, Study chair, Mayo ClinicChris Parker, M.D, Study chair, Royal Marsden Hospital, Sulton, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499174
- Sponsor's protocol ID
- PR11
- Other IDs
- U10CA077202, CAN-NCIC-CTG-PR11, CALGB-140602, SWOG-PR11, CDR0000557348, RTOG-0873, ECOG-JPR.11, ICR-CTSU-ProSTART
- Status last verified
- May 2021
- First submitted
- 10 Jul 2007
- Last updated
- 23 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23411385
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed With Favourable Risk Prostate Cancer [START]
- ClinicalTrials.gov ID
- NCT00499174
- Acronym / sponsor ID
- PR11
- Conditions
- Prostate Cancer
- Keywords
- stage II prostate cancer, adenocarcinoma of the prostate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not meeting accrual target.
- Enrolment
- 180 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Collaborators
- National Cancer Institute (NCI), Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, SWOG Cancer Research Network, Radiation Therapy Oncology Group, Institute of Cancer Research, United Kingdom
- Study start
- 6 Dec 2007 (actual)
- Primary completion
- 31 Dec 2011 (actual)
- Study completion
- 10 Jan 2013 (actual)
- First posted
- 11 Jul 2007 (estimated)
- Results
- Posted 12 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Surveillance | No intervention | –Active surveillance with radical intervention at the time one or more of the following occur: Biochemical progression; Grade progression; Clinical progression |
| Radical Intervention | Active comparator | Procedure: conventional surgery, Radiation: brachytherapy, Radiation: external beam radiation therapy, Procedure: BiopsiesRadical prostatectomy or radiotherapy based on patient and physician preference |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional surgeryRadical prostatectomy | Procedure or surgery | Radical Intervention |
| brachytherapyhigh dose rate temporary seed implant; permanent seed implant. | Radiation | Radical Intervention |
| external beam radiation therapy3D conformal radiation therapy; intensity modulated radiation therapy. | Radiation | Radical Intervention |
| BiopsiesPeriodic repeat biopsies | Procedure or surgery | Radical Intervention |
Primary outcome
Disease-specific Survival
Time frame: 5 years 6 months
Time from the date of randomization to the date of death due to prostate cancer.
1 secondary outcome
Overall Survival
Time frame: 5 years 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23411385Fung-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence H. Klotz, MD study chair
Toronto Sunnybrook Regional Cancer Centre
Adam S. Kibel, MD study chair
Washington University Siteman Cancer Center
Martin G. Sanda, MD study chair
Beth Israel Deaconess Medical Center
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional surgery, brachytherapy and external beam radiation therapy in people with Prostate Cancer, run by NCIC Clinical Trials Group at 13 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-specific Survival (time frame: 5 years 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00499174, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.