Trial from ANZCTR


Trial ID ACTRN12611000781943
Trial Status: Registered
Date Submitted: 11/05/2009
Date Registered: 26/07/2011
Retrospectively registered

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Public title Radiotherapy following radical prostatectomy - Adjuvant Versus Early Salvage
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Trans Tasman Radiation Oncology Group (TROG) 08.03 - A Phase III Multi-Centre Randomised Trial Comparing biochemical failure following Adjuvant Radiotherapy (RT) versus Early Salvage RT in Patients With Positive Margins or Extraprostatic Disease Following Radical Prostatectomy.
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Secondary ID [1] 861 0
ClinicalTrials.gov ID NCT00860652
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UTN
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Trial acronym RAVES
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Health condition(s) or problem(s) studied:
Prostate Cancer 4751 0
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Condition category: Condition code:
Cancer Prostate
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237088 237088 0 0

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Descriptions of intervention(s) / exposure Arm 1: Standard Arm - Adjuvant Radiotherapy. Radiation: Adjuvant radiation therapy (ART) commenced within 4 months of Radical Prostatectomy (RP). 64Gy in 32 fractions to the prostate bed, radiotherapy will be delivered 1 fraction/day over approx 6.5 weeks.
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Intervention Code:
Treatment: Other 4525 0
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Comparator / control treatment Arm 2: Experimental - Active Surveillance with early salvage radiotherapy. Radiation: Early Salvage Radiotherapy. Active surveillance with early salvage RT (SRT). 64Gy in 32 fractions to the prostate bed, radiotherapy will be delivered 1 fraction/day over approx 6.5 weeks. The trigger for SRT is PSA (Prostate Speicific Antigen) level >= 0.2ng/ml. RT should commence as soon as possible )no later than 4 months) following the first PSA measurement >= 0.2ng/ml.
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Control group Active
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Primary Outcome: Biochemical failure: PSA >=0.4ng/ml and rising following RT. PSA will be measured through blood tests. 5921 0
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Timepoint: After 160 events have been observed, expected to be 5 years after the end of accrual.
Arm 1, Adjuvant Radiotherapy - 6 weeks post RT, then 6 monthly until the end of trial
Arm 2, Surveillance - every three months from randomisation for the first 5 years, then 6 monthly thereafter until rising PSA
5921 0
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Secondary Outcome: Quality of Life. European Organisation for Research and Treatment of Cancer (EORTC) core quality of Life questionnaire (QLQ-C30) and EORTC (prostate Cancer module) QLQ-PR25 questionnaires 241999 0
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Timepoint: Pre-randomisation, Day 1 Radiotherapy (RT), last day RT and 6 weeks following completion of RT, then annually for 5 years. 241999 0
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Secondary Outcome: Toxicity. Measured using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Effects (CTCAE) v 3.0 242000 0
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Timepoint: Final analysis will be after 160 events, estimated to be 5 years after the end of accrual. 242000 0
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Secondary Outcome: Anxiety/Depression. Measured using the Hospital Anxiety and Depression Scale (HADS). 242001 0
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Timepoint: Pre-randomisation, Day 1 Radiotherapy (RT), last day RT and 6 weeks following completion of RT, then annually for 5 years. 242001 0
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Secondary Outcome: Biochemical Failure free survival. Measured from date of randomisation to date of biochemical failure or death from any cause. Measured via Blood PSA tests. 242002 0
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Timepoint: Final analysis will be after 160 events, estimated to be 5 years after the end of accrual.
Arm 1, Adjuvant Radiotherapy - 6 weeks post RT, then 6 monthly until the end of trial
Arm 2, Surveillance - every three months from randomisation for the first 5 years, then 6 monthly thereafter until rising PSA
242002 0
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Secondary Outcome: Overall Survival. Measured from date of randomisation to date of death from any cause. Local sites are responsible for reporting patient survival status. A patient will not be reported to have died unless there is source data confirming the patient?s death. Examples of potential source data are the patient?s medical records, obituaries, public records, death certificate, or information provided by a GP, hospice staff, or patient family members. If a patient is lost to follow-up, death will not be assumed unless confirmatory source data is available. The trial forms have been designed to allow sites to report lost to follow-up and death as separate events. 242003 0
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Timepoint: Final analysis will be after 160 events, estimated to be 5 years after the end of accrual. Clinical assessment - Every 6 months from randomisation for the first 5 years, then annually until the end of the trial.
PSA - Arm 1, Adjuvant Radiotherapy - 6 weeks post RT, then 6 monthly until the end of trial
Arm 2, Surveillance - every three months from randomisation for the first 5 years, then 6 monthly thereafter until rising PSA
242003 0
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Secondary Outcome: Diseaese specific survival. Measured from the date of randomisation to date of death due to prostate cancer. Data linkage to medical records 242004 0
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Timepoint: Final analysis will be after 160 events, estimated to be 5 years after the end of accrual. 242004 0
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Secondary Outcome: Time to distant failure. Measured from date of randomisation to date of documented regional, nodal or distant failure. Nodal failure - diagnosed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) of pelvis/abdomen.
Bone Metastases - confirmed on x-ray, bone scan, CT/MRI.
242005 0
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Timepoint: Baseline, 6 monthly from randomisation for first 5 years, then annually until the end of trial. 242005 0
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Secondary Outcome: Time to local failure. Measured from date of randomisation to date of documented palpable or biopsy-proven local failure. 242006 0
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Timepoint: Final analysis will be after 160 events, estimated to be 5 years after the end of accrual. Baseline, 6 monthly from randomisation for first 5 years, then annually until the end of trial. 242006 0
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Secondary Outcome: Time to initiation of androgen ablation. Measured from date of randomisation to the date of initiaion of androgen deprivation. 242007 0
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Timepoint: Final analysis will be after 160 events, estimated to be 5 years after the end of accrual. Baseline, 6 monthly from randomisation for first 5 years, then annually until the end of trial. 242007 0
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Secondary Outcome: Quality Adjusted Life Years. Assessing efficacy and Quality of Life. 242008 0
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Timepoint: Final analysis will be after 160 events, estimated to be 5 years after the end of accrual. 242008 0
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Key inclusion criteria 1. Prior radical prostatectomy (RP) for adenocarcinoma of the prostate. 2. Histological confirmation of adenocarcinoma of the prostate with Gleason score reported (RP specimen). 3. Patients must have at least one of the following risk factors: a) positive margins, b) extraprostatic extension (EPE) with or without seminal vesicle involvement (pT3a or pT3b). 4. Capable of starting RT within 4 months of RP (a requirement if randomised to adjuvant RT arm). 5. Most recent PSA <= 0.1ng/ml following RP and prior to randomisation. 6. European Cooperative Oncology Group (ECOG) performance status 0-1. 7. Patient able to adhere to the specified follow-up schedule and complete the Quality Of Life and anxiety/depression self assessments. 8. Written informed consent obtained prior to randomisation. 9. Completion of all pre-treatment evaluations. 10. 18 years or older.
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Minimum age 18 Years
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Maximum age No limit
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Gender Males
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Healthy volunteers? No
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Key exclusion criteria 1. Previous pelvic RT. 2. Concurrent or previous malignancy 5 years prior to randomisation (except non-melanomatous skin cancer). 3. Androgen deprivation (AD) prior to or following RP. 4. Evidence of nodal or distant metastases. 5. Co-morbidities that would interfere with the completion of treatment or 5 years of follow-up. 6. Concurrent cytotoxic medication. 7. Hip prothesis
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Patients will be registered via the internet. The Trial Centre will provide each participating site with a user account to access the web-based system. To register a patient, complete electronic case report forms (CRFs) to document eligibility and stratification fators. Prior to patient registration, the investigator should ensure that
all of the following requirements are met:
- Informed consent has been obtained prior to performing any study specific procedures
- The patient meets all inclusion criteria and none of the exclusion criteria should apply.
- All pre-registration assessments and investigations have been performed.
- The eligibility checklist has been completed, signed and dated.

Once registered, patients will be randomised to one of two treatment arms via a web based randomisation using the minisation technique.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Stratification: Pre-operative PSA; Gleason score; Margin positivity; Seminal vesicle involvement; Radiotherapy Institution.
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Masking / blinding
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Phase 3
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Anticipated date of first participant enrolment 30/03/2009
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Date of first participant enrolment 30/03/2009
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Anticipated date last participant recruited/enrolled 30/03/2014
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Actual date last participant recruited/enrolled
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Target sample size 470
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Recruitment status Recruiting
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Recruitment in Australia

Recruitment state(s) NSW,VIC,QLD,WA,TAS
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Hospital: The Alfred - Prahran 576 0
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Hospital: Austin Health - Heidelberg Repatriation Hospital - Heidelberg West 577 0
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Hospital: Calvary Mater Newcastle - Waratah 578 0
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Hospital: Campbelltown Hospital - Campbelltown 579 0
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Hospital: Coffs Harbour Base Hospital - Coffs Harbour 580 0
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Hospital: Liverpool Hospital - Liverpool 581 0
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Hospital: Nepean Hospital - Kingswood 582 0
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Hospital: Peter MacCallum Cancer Institute - East Melbourne 583 0
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Hospital: Port Macquarie Base Hospital - Port Macquarie 584 0
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Hospital: Princess Alexandra Hospital - Woolloongabba 585 0
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Hospital: Riverina Cancer Care Centre - Wagga Wagga 586 0
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Hospital: Royal Brisbane & Womens Hospital - Herston 587 0
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Hospital: Royal Hobart Hospital - Hobart 588 0
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Hospital: Royal North Shore Hospital - St Leonards 589 0
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Hospital: Royal Perth Hospital - Perth 590 0
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Hospital: Royal Prince Alfred Hospital - Camperdown 591 0
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Hospital: Sir Charles Gairdner Hospital - Nedlands 592 0
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Hospital: St George Hospital - Kogarah 593 0
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Hospital: The Townsville Hospital - Douglas 594 0
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Hospital: Sydney Adventist Hospital - Wahroonga 595 0
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Postcode: 3181 - Prahran 6322 0
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Postcode: 3081 - Heidelberg West 6323 0
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Postcode: 2310 - Hunter Region 6324 0
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Postcode: 2170 - Liverpool 6325 0
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Postcode: 2450 - Coffs Harbour 6326 0
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Postcode: 2747 - Kingswood 6327 0
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Postcode: 6014 - Wembley 6328 0
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Postcode: 8006 - Abeckett Street 6329 0
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Postcode: 2444 - Port Macquarie 6330 0
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Postcode: 4224 - Tugun 6331 0
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Postcode: 4102 - Woolloongabba 6332 0
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Postcode: 4101 - South Brisbane 6333 0
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Postcode: 2650 - Wagga Wagga 6334 0
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Postcode: 7000 - Hobart 6335 0
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Postcode: 2065 - Royal North Shore Hospital 6336 0
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Postcode: 6000 - Perth 6337 0
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Postcode: 2050 - Camperdown 6338 0
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Postcode: 2217 - Kogarah 6339 0
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Postcode: 2010 - Darlinghurst 6340 0
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Postcode: 2145 - Wentworthville 6341 0
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Postcode: 2076 - Wahroonga 6342 0
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Recruitment outside Australia

Country: New Zealand 1758 0
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State/Province: Palmerston North 1758 0
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Country: New Zealand 4862 0
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State/Province: Dunedin 4862 0
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Country: New Zealand 4863 0
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State/Province: Hamilton 4863 0
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Country: New Zealand 4864 0
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State/Province: Wellington 4864 0
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Country: New Zealand 4865 0
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State/Province: Auckland 4865 0
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Country: New Zealand 4866 0
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State/Province: Christchurch 4866 0
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Funding Source: Government body 4932 0
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Name: Australian National Health and Research Council 4932 0
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Address: Level 5 20 Allara St Canberra ACT 2601 4932 0
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Country: Australia 4932 0
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Funding Source: Other 4933 0
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Name: Royal Australian and New Zealand College of Radiologists 4933 0
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Address: Level 9 Druitt St Sydney NSW 2000 Australia 4933 0
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Country: Australia 4933 0
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Funding Source: Hospital 4934 0
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Name: Auckland City Hospital 4934 0
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Address: Auckland City Hospital
2 Park Road Grafton
Auckland 1023
4934 0
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Country: New Zealand 4934 0
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Funding Source: Government body 4935 0
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Name: Cancer Council Victoria 4935 0
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Address: 1 Rathdowne St Carlton VIC, 3053 Australia 4935 0
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Country: Australia 4935 0
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Funding Source: Government body 4936 0
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Name: Cancer Council NSW 4936 0
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Address: 153 Dowling St Woolloomooloo, NSW 2011 Australia 4936 0
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Country: Australia 4936 0
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Funding Source: Government body 4937 0
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Name: New Zealand Health and Research Council 4937 0
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Address: Level 3 110 Stanley St Auckland 1010 New Zealand 4937 0
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Country: New Zealand 4937 0
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Funding Source: Other 4939 0
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Name: Trans Tasman Radiation Oncology Group 4939 0
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Address: TROG Central Operations Office
Calvary Mater Newcastle
Locked Bag 7 HRMC
NSW 2310 Australia
4939 0
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Country: Australia 4939 0
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Primary Sponsor Other Collaborative groups
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Name: Trans Tasman Radiation Oncology Group (TROG)
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Address: TROG Central Operations Office Calvary Mater Newcastle Locked Bag 7 HRMC NSW 2310 Australia
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Country: Australia
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Secondary Sponsor: None 4460 0
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Name: 4460 0
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Address: 4460 0
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Country: 4460 0
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Other Collaborator: Other 667 0
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Name: Urological Society of Australia and New Zealand 667 0
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Address: Suite 512 East point
180 Ocean Street Edgecliff, NSW 2027 Australia
667 0
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Country: Australia 667 0
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Other Collaborator: Other Collaborative groups 277280 0
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Name: Australian & New Zealand Urogenital and Prostate Cancer Trials Group 277280 0
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Address: Level 4, 92-94 Parramatta Road, Camperdown NSW 2050 277280 0
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Country: Australia 277280 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Royal North Shore Hospital 7015 0
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Address: Level 2 Building 51
Royal North Shore Hospital
St Leonards, NSW 2065
7015 0
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Country: Australia 7015 0
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Approval Date: 30/10/2008 7015 0
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Submitted Date: 7015 0
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HREC: 08/HAWK/131 7015 0
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Brief summary This is a prospective, multi centre, international, randomised controlled trial with a 1:1 allocation ratio. Patients with positive margins and/or pT3 disease will be randomised to adjuvant RT (standard arm) or active surveillance with salvage RT delivered at early relapse (experimental arm). 64Gy in 32 fractions will be delivered to the prostate bed. QoL self-assessment questionnaires, Hospital Anxiety and Depression Score and toxicity will be assessed at baseline, the end of RT and annually for 5 years. Patients will be seen by their doctor 6 monthly for the first 5 years, tahn annually for the next 5 yaers. A blood test measuring prostate specific antigen (PSA) is done 3 monthly for the first 5 years for patients randomised to early salvage RT, than 6 monthly from years 5-10.
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Trial website www.trog.com.au
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Name: A/Prof Andrew Kneebone and Dr Maria Pearse (Co PIs)
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Address: Department of Radiation Oncology Royal North Shore Hospital Pacific Highway St Leonards NSW 2065 Australia and Oncology Department Auckland Regional Cancer and Blood Service Private Bag 92024 Auckland, New Zealand 1142
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Country: Australia
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Tel: +61 2 9926 5010 / +64095074949
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Fax:
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Email: AKneebone@nsccahs.health.nsw.gov.au & mariap@adhb.govt.nz
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Contact person for public queries
Title: Ms
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Name: Carol Fraser-Browne
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Address: Clinical Trial Centre Manager Oncology Department Auckland Regional Cancer and Blood Service Private Bag 92024 Auckland, New Zealand 1142
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Country: New Zealand
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Tel: +64 9 307 4949 ext 23044
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Fax: +64 9 359 9981
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Email: CarolFB@adhb.govt.nz
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Contact person for scientific queries
Title: A/Prof
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Name: Andrew Kneebone
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Address: Department of Radiation Oncology Royal North Shore Hospital Pacific Highway St Leonards NSW 2065 Australia
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Country: Australia
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Tel: +61 2 9926 5010
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Fax: +61 2 9906 4150
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Email: AKneebone@nsccahs.health.nsw.gov.au
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Contact person responsible for updating information
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Name: TROG Administrator
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Address: TROG Central Operations Office Calvary Mater Newcastle Locked Bag 7 HRMC NSW 2310 Australia
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Country: Australia
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Tel: +61 2 4014 3910
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Fax: +61 2 4014 3902
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Email: administrator@trog.com.au
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Addition Cancer fields
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