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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 001454
ACTR Number: ACTRN12606000301561
Trial Status: Registered
Date Submitted: 28/07/2004
Date Registered: 28/07/2004

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Public title: TOAD - Timing of androgen deprivation intervention in prostate cancer patients with a rising PSA
ANZCTR registration title: A collaborative randomised phase III trial: The timing Of intervention with Androgen Deprivation in prostate cancer patients with a rising Prostate Specific Antigen (PSA)
Secondary ID 1:VCOG PR 1-03 
Secondary ID 2:TROG 03.06 
Secondary ID 3:National Clinical Trials Registry: NCTR580 
Secondary ID 4:Trans-Tasman Radiation Oncology Group Inc (TROG): TROG 03.06 
UTN:
Trial acronym: TOAD

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Health condition(s) or problem(s) studied:
Prostate cancer 
Condition category: Condition code:
Cancer Prostate 

Page 3

Description of intervention(s) / exposure: Patients will be randomised to receive androgen deprivation therapy either immediately (experimental arm)
Intervention code:Treatment: Other 
Comparator / control treatment: Patients will be randomised to receive androgen deprivation therapy delayed for at least 2 years or until evidence of significant disease progression (control arm).
Control group: Active

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Primary outcome:The primary endpoint of the trial is death from any cause 
Timepoint:Measured at 6 monthly assessments 
Secondary outcome 1:Cancer specific survival 
Timepoint:6 monthly for 5 years 
Secondary outcome 2:Clinical progression 
Timepoint:6 monthly for 5 years 
Secondary outcome 3:Time to first androgen independence 
Timepoint:6 monthly for 5 years 
Secondary outcome 4:Complication rate incidence and timing (eg cord compression, pathological fracture) 
Timepoint:6 monthly for 5 years 
Secondary outcome 5:Treatment related morbidity (including cognitive, osteoporosis) 
Timepoint:6 monthly for 5 years 
Secondary outcome 6:Quality of life 
Timepoint:6 monthly for 5 years 
Secondary outcome 7:Prognostic factors for progression (delayed group) 
Timepoint:6 monthly for 5 years 

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Key inclusion criteria: STUDIES 1 AND 2- Histologically confirmed adenocarcinoma of the prostate- Accessible for follow-up- Informed consent to be randomised to immediate or delayed androgen deprivation- Males aged 18 years and overINCLUSION CRITERIA STUDY 1 PSA relapse after definitive radical treatment- No evidence of metastatic disease on staging investigations (bone scan, abdomino-pelvic CT scan)- Prior androgen deprivation limited to a maximum of seven months neo-adjuvant/concurrent treatment, completed at least 12 months prior to study entryINCLUSION CRITERIA STUDY 2- Not suitable for radical treatment at primary diagnosis.- Decision not to treat curatively- No symptoms due to local or metastatic disease requiring radiation or immediate hormone therapy- No prior androgen deprivation therapy
Minimum Age: 18 Years
Maximum Age: Not stated
Gender: Males
Healthy volunteers? No
Key exclusion criteria: Significant co-morbidity limiting life expectancy to less than 5 years- Patients with symptomatic disease requiring therapy- Previous androgen deprivation for longer than 7 months (Study 1)- Diagnosis of PSA relapse or incurable disease more than six months prior to randomisation- Patients entered into TROG studies 96.01 or RADAR- Patients with a PSA doubling time of less than 3 months (Study 1)

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Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Randomised controlled trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): Randomisation is performed centrally using computer software.
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation): Treatment is allocated using a database embedded dynamically balanced randomisation method.
Masking / blinding: Open (masking not used)
Assignment: Parallel
Other design features (specify):
Type of endpoint(s): Efficacy

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Phase Phase 3
Anticipated or actual date of first participant enrolement: 1/08/2004
Target sample size: 750
Recruitment status: Open to recruitment

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Funding source 1:Government funding body e.g. Australian Research Council 
Name:National Health & Medical Research Council 
Address:National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601 
Country:Australia 
Funding source 2:Commercial sector/Industry 
Name:untied pharmaceutical company grants 
Address:Hospira Level 6, 390 St Kilda Road Melbourne, VIC, 3004 
Country:Australia 
Primary sponsor: Charities/Societies/Foundations
Name: The Cancer Council Victoria
Address: 1 Rathdowne St, Carlton South, 3053, VIC
Country: Australia
Secondary sponsor:Other Collaborative groups 
Name:Trans Tasman Radiation Oncology Group (TROG) 
Address:Dept of Radiation Oncology Newcastle Mater Misericordiae Hospital Locked Bag7, NHMRC NSW 2310 
Country:Australia 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name 1:Alfred Hospital 
Address: 
Country:Australia 
Date of approval:25/10/2004 
HREC Number: 
Ethics Committee name 2:Campbelltown Hospital 
Address: 
Country:Australia 
Date of approval:6/12/2005 
HREC Number: 
Ethics Committee name 3:Cham, Mr Chee Wee 
Address: 
Country:Australia 
Date of approval:19/08/2005 
HREC Number: 
Ethics Committee name 4:Christchurch Hospital 
Address: 
Country:New Zealand 
Date of approval:19/04/2005 
HREC Number: 
Ethics Committee name 5: 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 6:Concord Repatriation Hosp 
Address: 
Country:Australia 
Date of approval:5/10/2004 
HREC Number: 
Ethics Committee name 7:Dunedin Hospital 
Address: 
Country:New Zealand 
Date of approval:24/06/2005 
HREC Number: 
Ethics Committee name 8:East Coast Cancer Centre 
Address: 
Country:Australia 
Date of approval:30/11/2004 
HREC Number: 
Ethics Committee name 9:Geelong Hospital 
Address: 
Country:Australia 
Date of approval:4/11/2004 
HREC Number: 
Ethics Committee name 10: 
Address: 
Country:Australia 
Date of approval:28/04/2006 
HREC Number: 
Ethics Committee name 11:Liverpool Hospital 
Address: 
Country:Australia 
Date of approval:6/11/2004 
HREC Number: 
Ethics Committee name 12:Mander, Mr Julian 
Address: 
Country:Australia 
Date of approval:19/05/2006 
HREC Number: 
Ethics Committee name 13:Mater QRI 
Address: 
Country:Australia 
Date of approval:9/09/2004 
HREC Number: 
Ethics Committee name 14:Monash Medical Centre 
Address: 
Country:Australia 
Date of approval:19/04/2006 
HREC Number: 
Ethics Committee name 15:Nepean Cancer Care Centre 
Address: 
Country:Australia 
Date of approval:29/03/2005 
HREC Number: 
Ethics Committee name 16:Newcastle Mater 
Address: 
Country:Australia 
Date of approval:18/03/2005 
HREC Number: 
Ethics Committee name 17:Peter MacCallum Cancer Centre 
Address: 
Country:Australia 
Date of approval:24/08/2004 
HREC Number: 
Ethics Committee name 18:Princess Alexandra Hospital 
Address: 
Country:Australia 
Date of approval:30/08/2004 
HREC Number: 
Ethics Committee name 19: 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 20:Repatriation General Hospital 
Address: 
Country:Australia 
Date of approval:4/08/2004 
HREC Number: 
Ethics Committee name 21:Royal Brisbane Hospital 
Address: 
Country:Australia 
Date of approval:3/08/2004 
HREC Number: 
Ethics Committee name 22:Royal Prince Alfred 
Address: 
Country:Australia 
Date of approval:23/08/2004 
HREC Number: 
Ethics Committee name 23:Sinclair, Mr Graham 
Address: 
Country:Australia 
Date of approval:28/06/2005 
HREC Number: 
Ethics Committee name 24:Sir Charles Gairdner Hospital 
Address: 
Country:Australia 
Date of approval:19/12/2005 
HREC Number: 
Ethics Committee name 25:Syme, Mr Rodney 
Address: 
Country:Australia 
Date of approval:1/03/2005 
HREC Number: 
Ethics Committee name 26:St George Hospital 
Address: 
Country:Australia 
Date of approval:16/03/2005 
HREC Number: 
Ethics Committee name 27:Vivian, Mr Justin 
Address: 
Country:Australia 
Date of approval:19/05/2006 
HREC Number: 
Ethics Committee name 28:Waikato Hospital 
Address: 
Country:New Zealand 
Date of approval:23/11/2004 
HREC Number: 
Ethics Committee name 29:Wellington Hospital 
Address: 
Country:New Zealand 
Date of approval: 
HREC Number: 
Ethics Committee name 30: 
Address: 
Country:Australia 
Date of approval:6/08/2004 
HREC Number: 
Ethics Committee name 31:Westmead Hospital 
Address: 
Country:Australia 
Date of approval:26/10/2004 
HREC Number: 
Ethics Committee name 32:Auckland City Hospital 
Address:Waikato DHB, Regional Cancer Centre, Private Bag, 3200 Hamilton, NZ 
Country:New Zealand 
Date of approval:26/10/2006 
HREC Number:WAI/04/07/058 
Ethics Committee name 33:Royal North Shore Hospital 
Address:Research Office, Level 4, Vindin House, RNSH, Pacific Hwy, St Leonards, NSW 2065 
Country:Australia 
Date of approval:16/09/2006 
HREC Number:0608-144M 
Ethics Committee name 34:Dr Henry Woo 
Address:New South Wales Cancer Council 
Country:Australia 
Date of approval:10/01/2005 
HREC Number:123 
Ethics Committee name 35:Illawarra Cancer Care Centre 
Address:SE Sydney and Illawarra Area Health Service Health and Medical HREC 
Country:Australia 
Date of approval:14/05/2008 
HREC Number:CT08/001 
Countries of recruitment:Australia 
Brief summary: This is a clinical trial for patients with prostate cancer. The aim of the project is to provide information about the best timing to start treatment in men who have a rising PSA (prostate specific antigen) blood test, after having had treatment with the aim of curing their prostate cancer. In some men, the surgery or radiotherapy given initially in the attempt to cure the cancer is not successful. One of the earliest ways of detecting recurrence of the cancer in these men is with the PSA blood test, which can detect activity of the cancer months or years before other tests, and usually long before any symptoms appear.
We know that treatment with hormone therapy – removing the male hormone testosterone – is helpful in controlling advanced disease causing symptoms, although it is not a cure. This is called ‘androgen deprivation’, testosterone being an androgen hormone. The cancer cells are deprived of a source of energy, keeping them under control for a while, but eventually they tend to start growing again in spite of the treatment. We know that using androgen deprivation usually causes the PSA level in men to fall, including men in your situation who have no other signs of active cancer. What we do not know is whether using androgen deprivation immediately the PSA starts to rise will prolong life more than waiting to start treatment until there are other signs that the disease is progressing.
It would be simple to start everyone on treatment with androgen deprivation if there were no side effects with the treatment. However, there are a number of side effects that may interfere with day-to-day living. These include (but are not limited to): hot flushes, tiredness, anaemia, and loss of muscle mass and bone density. There may be weight gain, and nipple tenderness or swelling. Some men notice changes in mental function, or shortness of breath. Most also find that sex drive and erectile function, if normal before starting treatment, cease. Quality of life may be affected. If androgen deprivation therapy is ceased, some of the side effects (such as loss of sex drive, loss of muscle bulk or bone mineral density) may be halted or reversed. Generally the standard approach would be to delay introducing treatment until the disease progresses.
So the purpose of the study is to see whether immediate treatment is better or worse than delayed treatment in terms of prolonging lifespan, balanced against the effects on the quality of life.
Trial website:
Presentations / publication list:

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Contact person for public queries
Name: Deborah Howell
Address: The Cancer Council Victoria 1 Rathdowne Street Carlton VIC 3053
Country: Australia
Tel: +61(0)3 9635 5179
Fax: +61(0)3 9635 5410
Email: Deborah.Howell@cancervic.org.au

Contact person for scientific queries
Name: Prof Gillian Duchesne
Address: Director Radiation Oncology Peter MacCallum Cancer Centre Locked Bag 1 A'Beckett Street Melbourne Victoria 8001
Country: Australia
Tel: +61(0)3 9656 1004
Fax: +61(0)3 9656 1424
Email: Gillian.Duchesne@petermac.org

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