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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: 081972
ACTR Number: ACTRN12607000237482
Trial Status: Registered
Date Submitted: 18/12/1995
Date Registered: 18/12/1995

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Public title: A randomised trial investigating the effectiveness of different durations of maximal androgen deprivation prior to and during definitive radiation therapy for locally advanced carcinoma of the prostate
ANZCTR registration title: Trans Tasman Radiation Oncology Group (TROG) 96.01 - A randomised trial investigating the effectiveness of different durations of maximal androgen deprivation (using Zoladex and Eulexin) prior to and during definitive radiation therapy for locally advanced carcinoma of the prostate to reduce the rate of local recurrence.
Secondary ID:National Clinical Trials Registry: NCTR140 
UTN:
Trial acronym: TROG 96.01

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

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Description of intervention(s) / exposure: Arm A: Maximal androgen deprivation for 2 months prior to and during radiation therapy (total 3 months) Arm B: Maximal androgen deprivation for 5 months prior to and during radiation therapy (total 6 months).
Androgen Deprivation: Zoladex 3.6 mg monthly (every 29 days Sub cutaneous); Eulexin (Flutamide) 250 mg orally three times a day, for either - Two months prior to the commencement of radiation therapy and for one month during radiation therapy (ie 3 months total) or Five months prior to the commencement of radiation therapy and for one month during radiation therapy (ie 6 months total).
Intervention code:Treatment: drugs 
Comparator / control treatment: Arm C: Radiation therapy alone. Radiotherpay Treatment: 66 Gy in 33 daily fractions over 6.5-7 weeks.
Control group: Active

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Primary outcome:Improve local control 
Timepoint:Follow-up schedule is 2 months following radiation therapy, then every 4 months for 18 months. Every 6 months thereafter until 10 years follow up of each patient. 
Secondary outcome 1:Prevent systemic metastases 
Timepoint:Follow-up schedule is Two months following radiation therapy, then every 4 months for 18 months. Every 6 months thereafter until 10 years follow up of each patient. 
Secondary outcome 2:Overall survival 
Timepoint:Follow-up schedule is Two months following radiation therapy, then every 4 months for 18 months. Every 6 months thereafter until 10 years follow up of each patient. 

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Key inclusion criteria: Eligible patients will be those with histologically confirmed, locally advanced adenocarcinoma of the prostate. Included will be patients with primary tumours confined to but diffusely involving more than half of the prostate (clinical stage T2b, c [B2]) or extending beyond the capsule (clinical stage T3, 4 [C]). Patients without regional lymph node involvement demonstrable on CT scan, lymphography or pelvic node sampling- Performance status must be equal to or less than ECOG 1- Eligible patients should be willing to accept the side-effects of maximal androgen deprivation therapy as defined herein- All institutional and ethical guidelines must be followed and all patients must sign an informed consent prior to being placed in the study.
Minimum Age: 18 Years
Maximum Age: No limit
Gender: Males
Healthy volunteers? No
Key exclusion criteria: Stage T1 or T2a (A or B1) disease- Evidence of distant metastases- Lymph node involvement, either clinically, radiologically or pathologically- Radical surgery for carcinoma of the prostate, previous radiation, hormonal manipulation or chemotherapy- Previous or concurrent cancers other than non-melanomatous skin cancer- Major intercurrent physical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment or adequate follow-up either through disablement or limitation of life expectancy to less than 1 year- Performance status of greater than 1 on the ECOG scale

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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): central randomisation by phone /computer
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation): Simple randomisation by computer
Masking / blinding: Open (masking not used)
Assignment: Parallel
Other design features (specify):
Type of endpoint(s): Safety/efficacy

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Phase Phase 3
Anticipated or actual date of first participant enrolement: 24/06/1996
Target sample size: 650
Recruitment status: Closed: follow-up continuing

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Funding source:Government funding body e.g. Australian Research Council 
Name:National Health & Medical Research Council Project Grant 
Address:Level 5, 20 Allara St Canberra ACT 2601 
Country:Australia 
Primary sponsor: Individual
Name: Jim Denham
Address: Edith St Waratah NSW 2298
Country: Australia
Secondary sponsor:Other Collaborative groups 
Name:Trans Tasman Radiation Oncology Group (TROG) 
Address:Edith St Waratah NSW 2298 
Country:Australia 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name 1:Calvary Mater Newcastle 
Address:Waratah, NSW 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 2:Canberra Hospital 
Address:Garran, ACT 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 3:Royal Prince Alfred Hospital 
Address:Camperdown, NSW 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 4:St Vincents Hospital 
Address:Sydney, NSW 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 5:Westmead Hospital 
Address:Wentworhville, NSW 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 6:Premion - Tugun 
Address:Tugun, QLD 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 7:Mater Centre QRI 
Address:South Brisbane, QLD 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 8:North Queensland Oncology Service 
Address:Townsville. QLD 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 9:Barwon Health - Andrew Love Cancer Care Centre, Geelong Hospital 
Address:Geelong, VIC 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 10:Austin Hospital 
Address:Heidelberg, VIC 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 11:Peter MacCallum Cancer Centre 
Address:East Melbourne, VIC 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 12:Launceston General Hospital 
Address:Launceston, TAS 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 13:Sir Charles Gairdner Hospital 
Address:Nedlands, WA 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 14:Auckland Hospital 
Address:Auckland, NZ 
Country:New Zealand 
Date of approval: 
HREC Number: 
Ethics Committee name 15:Christchurch Hospital 
Address:Christchurch, NZ 
Country:New Zealand 
Date of approval: 
HREC Number: 
Ethics Committee name 16:Dunedin Hospital 
Address:Dunedin, Otago, NZ 
Country:New Zealand 
Date of approval: 
HREC Number: 
Ethics Committee name 17:Royal Brisbane and Women's Hospital 
Address:Brisbane, QLD 
Country:Australia 
Date of approval: 
HREC Number:New ethics HREC. Please modify. 
Ethics Committee name 18:Wellington Hospital 
Address:Wellington, NZ 
Country:New Zealand 
Date of approval: 
HREC Number:New ethics HREC. Please modify. 
Countries of recruitment:Australia 
Postcode:Outside Australia 
New Zealand 
Brief summary: This trial is designed primarily to determine whether maximal androgen deprivation, prior to and during radiation therapy, reduces the rate of local failure and appearance of metastases that takes place after radiation therapy. A secondary aim is to determine whether a short period of androgen deprivation (3 months) is as effective as a longer period (6 months). A tertiary aim to see whether the tumour shrinkage caused by androgen deprivation prior to radiation therapy leads to any noticeable reduction in the long-term side-effects of subsequent radiation therapy. By defining the tolerability of and compliance with the regimens used, the final objective is to determine whether androgen deprivation as produced in this study is applicable for widespread use outside of the randomised clinical trial setting.
Trial website:
Presentations / publication list:

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Contact person for public queries
Name: Allison Steigler
Address: Department of Radiation Oncology Locked Bag 7 Hunter Region Mail Centre NSW 2310
Country: Australia
Tel: +61 2 49211181
Fax:
Email: Allison.Steigler@mater.health.nsw.gov.au

Contact person for scientific queries
Name: Jim Denham
Address: Department of Radiation Oncology Locked Bag 7 Hunter Region Mail Centre NSW 2310
Country: Australia
Tel: +61 2 49211180
Fax: +61 2 49211465
Email: Jim.Denham@newcastle.edu.au

Contact person responsible for updating information
Name: Erin Nolan
Address: Department of Radiation Oncology Locked Bag 7 Hunter Region Mail Centre NSW 2310
Country: Australia
Tel: +61 2 4014 3912
Fax: +61 2 4014 3902
Email: Erin.Nolan@trog.com.au
   
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