Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000027910
Ethics application status
Approved
Date submitted
17/12/2009
Date registered
10/01/2011
Date last updated
6/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A phase III study of active surveillance therapy against radical treatment in patients diagnosed with favourable risk prostate cancer (START)
Scientific title
A phase III study comparing the disease-specific survival of active surveillance therapy against radical treatment in patients diagnosed with favourable risk prostate cancer (START).
Secondary ID [1] 1209 0
National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) Protocol Number PR.11
Secondary ID [2] 253350 0
The Cancer and Leukemia Group B (CALGB) Protocol Number 140602
Secondary ID [3] 253351 0
Eastern Cooperative Oncology Group (ECOG) Protocol Number JPR.11
Secondary ID [4] 253352 0
Radiation Therapy Oncology Group (RTOG) Protocol Number 0873
Secondary ID [5] 253353 0
The Southwest Oncology Group (SWOG) Protocol Number PR.11
Secondary ID [6] 253354 0
The Institute of Cancer Research Clinical Trials & Statistics Unit (ICR-CTSU) Protocol Number ProSTART
Secondary ID [7] 253361 0
ClinicalTrials.gov NCT00499174
Universal Trial Number (UTN)
Trial acronym
START
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 256419 0
Condition category
Condition code
Cancer 256593 256593 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1:
Radical intervention (radical prostatectomy or radiotherapy based on patient and physician preference) within 90 days of randomisation.
Intervention code [1] 255714 0
Treatment: Surgery
Intervention code [2] 255715 0
Treatment: Other
Comparator / control treatment
Arm 2:
Active surveillance (monitoring your cancer closely or 'watchful waiting') with radical intervention at the time one or more of the following occur:
* Biochemical progression
* Grade progression
* Clinical progression
Control group
Active

Outcomes
Primary outcome [1] 257479 0
Disease-specific survival. This is defined as the time from randomisation to the time of death from prostate cancer or death with metastatic hormone refractory prostate cancer or death from disease and protocol treatment complication. Cause of death will be reviewed by a blinded endpoint review committee. The disease specific survival experience of patients in both treatment groups will be described by the Kaplan-Meier method. A stratified log-rank test, adjusting for the stratification factors (except centre) will be used as the primary method to compare the overall survival between the two arms, as well as confidence intervals for the estimated hazard ratio.
Timepoint [1] 257479 0
Follow-up after the completion of the assigned treatment strategy is every 6 months for up to 5 years or until the time of death from prostate cancer or death with metastatic hormone refractory prostate cancer, or death from disease and protocol treatment complication.
Secondary outcome [1] 262668 0
Overall survival. This is defined as the time from randomization to the time of death from any cause or last follow-up.
Timepoint [1] 262668 0
Follow-up after the completion of the assigned treatment strategy is every 6 months for up to 5 years or until the time of death from any cause or last completed follow-up.
Secondary outcome [2] 262669 0
Quality of life will be assessed using a short version of the EPIC-26, RAND SF-12, and State-Trait Anxiety Inventory instruments.
Timepoint [2] 262669 0
Comparisons between the quality of life of men randomised to immediate treatment compared to those randomized to active surveillance will be assessed with a questionnaire completed <= 30 days before randomisation, followed by an after randomisation questionnaire every 6 months whilst on active surveillance, with timing as follows if recieving radical intervention on either arm:

Surgery: The completion of surgery is the last day of hospitalisation. Quality of life questionnaires should be completed prior to discharge and patients given the 2 and 4 months forms at that time.

Brachytherapy: The completion of brachytherapy is the day of treatment. Quality of life questionnaires should be completed approximately one week after the procedure.

External beam: Treatment completion is the last review session. Quality of life questionnaires should be completed at the last review session.
Secondary outcome [3] 262670 0
Distant disease-free survival.
Timepoint [3] 262670 0
This is measured from the time of randomisation by Radiology (bone scan, chest x-rays, CTs) and Serum PSA (blood tests). Radiology will be conducted as clinically indicated. Serum PSA (blood tests) will take place every 3 months for 2 years post-randomisation then every 6 months during active surveillance, and every 6 months during and post any radical intervention until the detection of distant metastases or death.
Secondary outcome [4] 262671 0
PSA relapse/progression after radical intervention. This is defined as the following:

After Radical Prostatectomy:
A rise in PSA to greater than 0.4 (ng/ml or ug/L) post prostatectomy.

After External Beam Radiation:
Rising PSA with or without palpable tumour. A rise of 2 ng/mL or more above the nadir PSA (defined as the lowest PSA achieved). The date of failure is the date of the 2ng/mL or more rise above the nadir PSA.

After Brachytherapy:
Rising PSA with or without palpable tumour. Three consecutive rises above nadir. The date of failure is calculated at the midway between the PSA nadir and the first rise.
Timepoint [4] 262671 0
PSA relapse/progress after radical intervention is assessed post radical intervention (radical prostatectomy, external beam radiation, brachytherapy) every 6 months during and post any radical intervention until the detection of distant metastases or death.
Secondary outcome [5] 262672 0
Initiation of androgen deprivation therapy. Androgen deprivation therapy is defined as LHRH analogues, orchiectomy or anti-androgen monotherapy.
Timepoint [5] 262672 0
This is the time from randomisation to the initiation of androgen deprivation therapy.
Secondary outcome [6] 262673 0
Proportion of patients on the active surveillance arm receiving radical intervention.
Timepoint [6] 262673 0
This is the proportion of patients on the active surveillance arm who recieve radical intervention at the time one or more of the following occur during the follow-up period: * Biochemical progression (Conducted at randomisation and then, every 3 months for 2 years post-randomisation then every 6 months during active surveillance, and every 6 months during and post any radical intervention until the detection of distant metastases or death). * Grade progression (Gleason pattern predominant 4 i.e. Gleason 4+3 = 7 or higher) in the re-biopsy of prostate conducted at years 1, 4, 7, 10 and then every 5 years during active surveillance until death, and in addition, at the time of radical prostatectomy (if applicable or undertaken). * Clinical progression / Local Progression (Local progression of prostate cancer resulting in urinary retention, gross hematuria or hydronephrosis or evidence of distant metastasis, as defined by radiology/cytology/histology at sites remote from prostate and regional lymph nodes, assessed as per the timepoints for serum PSA blood tests, imaging and biopsy outlined above).
Secondary outcome [7] 262674 0
Prognostic significance of PSA doubling-time prior to diagnosis
Timepoint [7] 262674 0
This analysis could be performed after 24 months follow-up is obtained for all participants.
Secondary outcome [8] 262675 0
Prognostic significance of molecular biomarkers
Timepoint [8] 262675 0
This analysis could be performed after 24 months follow-up is obtained for all participants.

Eligibility
Key inclusion criteria
Patients must fulfil all of the following criteria to be eligible for admission to the study: * Histologically confirmed adenocarcinoma of the prostate diagnosed within 6 months prior to randomization. & Patient has been classified as favourable risk as defined by the following: * Clinical stage T1b, T1c, T2a or T2b at the time of diagnosis; Clinical (diagnostic biopsy) Gleason sum < 7; PSA < 10.0 ng/ml (ug/L) Note: patients who have received prior treatment with 5-alpha reductase inhibitors (5ARI) must adhere to the following criteria: * < 2 months duration of 5ARI exposure (prior to date of baseline PSA) must have a PSA value of < 10.0 (ng/ml or ug/L) to be eligible. * 2-6 months duration of 5ARI exposure (prior to date of baseline PSA) must have a PSA value of < 7.0 (ng/ml or ug/L) to be eligible. * > 6 months months duration of 5ARI exposure (prior to date of baseline PSA) must have a PSA value of < 5.0 (ng/ml or ug/L) to be eligible. * 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. * No previous treatment for prostate cancer including surgery (excluding biopsy), radiation therapy, and androgen deprivation therapy for greater than 3 months. * ECOG Performance Status 0, 1 or 2. * Patient has a minimum life expectancy of > 10 years. * The patient is willing to complete the quality of life questionnaires in English unless unable due to illiteracy in English, loss of sight, or other equivalent reason. * Patient consent has been obtained according to local Institutional and/or University Human Experimentation Committee requirements. * Patient is accessible for treatment and follow-up. * Protocol treatment is to begin within 90 days of randomisation.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who fulfil any of the following criteria are not eligible for admission to the study:
* History of other malignancies, except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer or other solid tumours curatively treated with no evidence of disease for > 5 years from randomisation.
* Planned androgen therapy except in the context of radical therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA,WA,TAS
Recruitment outside Australia
Country [1] 2371 0
Canada
State/province [1] 2371 0
Country [2] 2372 0
United States of America
State/province [2] 2372 0
Country [3] 2373 0
New Zealand
State/province [3] 2373 0

Funding & Sponsors
Funding source category [1] 258271 0
Government body
Name [1] 258271 0
Cancer Australia
Country [1] 258271 0
Australia
Funding source category [2] 258272 0
Charities/Societies/Foundations
Name [2] 258272 0
Prostate Cancer Foundation of Australia
Country [2] 258272 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
NHMRC Clinical Trials Centre
Level 6, Medical Foundation Building
The University of Sydney
92-94 Parramatta Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 251530 0
None
Name [1] 251530 0
Address [1] 251530 0
Country [1] 251530 0
Other collaborator category [1] 251755 0
Other Collaborative groups
Name [1] 251755 0
Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited
Address [1] 251755 0
ANZUP Cancer Trials Group Limited
Level 4, Medical Foundation Building
92 - 94 Parramatta Road
Camperdown NSW 2050
Country [1] 251755 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258295 0
Cancer Institute NSW Clinical Research Ethics Committee
Ethics committee address [1] 258295 0
Ethics committee country [1] 258295 0
Australia
Date submitted for ethics approval [1] 258295 0
Approval date [1] 258295 0
28/04/2011
Ethics approval number [1] 258295 0
AU RED Reference Number: HREC/11/CIC/4
Cancer Institute NSW Reference Number: 2001c/02/153

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30628 0
Address 30628 0
Country 30628 0
Phone 30628 0
Fax 30628 0
Email 30628 0
Contact person for public queries
Name 13875 0
ANZUP Associate Oncology Program Manager
Address 13875 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 13875 0
Australia
Phone 13875 0
+61 2 9562 5000
Fax 13875 0
+61 2 9562 5094
Email 13875 0
[email protected]
Contact person for scientific queries
Name 4803 0
ANZUP Associate Oncology Program Manager
Address 4803 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 4803 0
Australia
Phone 4803 0
+61 2 9562 5000
Fax 4803 0
+61 2 9562 5094
Email 4803 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.