Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000237482
Ethics application status
Approved
Date submitted
18/12/1995
Date registered
18/12/1995
Date last updated
26/06/2024
Date data sharing statement initially provided
26/06/2024
Date results provided
26/06/2024
Type of registration
Prospectively registered

Titles & IDs
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
Scientific 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
Secondary ID [1] 64 0
National Clinical Trials Registry: NCTR140
Universal Trial Number (UTN)
Trial acronym
TROG 96.01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 60 0
Condition category
Condition code
Cancer 2413 2413 0 0
Prostate

Intervention/exposure
Study type
Interventional
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 [1] 1710 0
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

Outcomes
Primary outcome [1] 100 0
Cause specific survival
Timepoint [1] 100 0
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. Patients can be seen annually after 5 years if free of all signs of cancer and subject to clinician discretion.
Primary outcome [2] 262153 0
Overall survival
Timepoint [2] 262153 0
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. Patients can be seen annually after 5 years if free of all signs of cancer and subject to clinician discretion.
Secondary outcome [1] 201 0
PSA progression
Timepoint [1] 201 0
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. Patients can be seen annually after 5 years if free of all signs of cancer and subject to clinician discretion.
Secondary outcome [2] 202 0
Local progression - diagnosed by DRE, or biopsy or trans-urethral resection performed at least 2 years post radiotherapy (to avoid false positives)
Timepoint [2] 202 0
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. Patients can be seen annually after 5 years if free of all signs of cancer and subject to clinician discretion.
Secondary outcome [3] 273238 0
Distant progression - diagnosed by bone scan, chest x-ray, CT scan or ultrasound of abdomen
Timepoint [3] 273238 0
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. Patients can be seen annually after 5 years if free of all signs of cancer and subject to clinician discretion.

Eligibility
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
Sex
Males
Can healthy volunteers participate?
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

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)
central randomisation by phone /computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/06/1996
Actual
28/06/1996
Date of last participant enrolment
Anticipated
Actual
16/02/2000
Date of last data collection
Anticipated
Actual
31/08/2010
Sample size
Target
800
Accrual to date
Final
818
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,WA,VIC
Recruitment outside Australia
Country [1] 515 0
New Zealand
State/province [1] 515 0

Funding & Sponsors
Funding source category [1] 101 0
Government body
Name [1] 101 0
National Health & Medical Research Council Project Grant
Country [1] 101 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Trans Tasman Radiation Oncology Group (TROG)
Address
Newcastle Mater Calvary
Locked Bag 7 HRMC NSW 2310
Country
Australia
Secondary sponsor category [1] 77 0
Individual
Name [1] 77 0
Professor Jim Denham
Address [1] 77 0
University of Newcastle
University Drive
Callaghan NSW 2308
Country [1] 77 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 671 0
Calvary Mater Newcastle
Ethics committee address [1] 671 0
Ethics committee country [1] 671 0
Australia
Date submitted for ethics approval [1] 671 0
Approval date [1] 671 0
22/03/1996
Ethics approval number [1] 671 0
Ethics committee name [2] 672 0
Canberra Hospital
Ethics committee address [2] 672 0
Ethics committee country [2] 672 0
Australia
Date submitted for ethics approval [2] 672 0
Approval date [2] 672 0
10/02/1999
Ethics approval number [2] 672 0
Ethics committee name [3] 673 0
Royal Prince Alfred Hospital
Ethics committee address [3] 673 0
Ethics committee country [3] 673 0
Australia
Date submitted for ethics approval [3] 673 0
Approval date [3] 673 0
04/03/1997
Ethics approval number [3] 673 0
Ethics committee name [4] 674 0
St Vincents Hospital
Ethics committee address [4] 674 0
Ethics committee country [4] 674 0
Australia
Date submitted for ethics approval [4] 674 0
Approval date [4] 674 0
23/03/1997
Ethics approval number [4] 674 0
Ethics committee name [5] 675 0
Westmead Hospital
Ethics committee address [5] 675 0
Ethics committee country [5] 675 0
Australia
Date submitted for ethics approval [5] 675 0
Approval date [5] 675 0
09/08/1996
Ethics approval number [5] 675 0
Ethics committee name [6] 676 0
Premion - Tugun
Ethics committee address [6] 676 0
Ethics committee country [6] 676 0
Australia
Date submitted for ethics approval [6] 676 0
Approval date [6] 676 0
12/06/1998
Ethics approval number [6] 676 0
Ethics committee name [7] 677 0
Mater Centre QRI
Ethics committee address [7] 677 0
Ethics committee country [7] 677 0
Australia
Date submitted for ethics approval [7] 677 0
Approval date [7] 677 0
15/06/1996
Ethics approval number [7] 677 0
Ethics committee name [8] 678 0
North Queensland Oncology Service
Ethics committee address [8] 678 0
Ethics committee country [8] 678 0
Australia
Date submitted for ethics approval [8] 678 0
Approval date [8] 678 0
11/03/1998
Ethics approval number [8] 678 0
Ethics committee name [9] 679 0
Barwon Health - Andrew Love Cancer Care Centre, Geelong Hospital
Ethics committee address [9] 679 0
Ethics committee country [9] 679 0
Australia
Date submitted for ethics approval [9] 679 0
Approval date [9] 679 0
23/06/1996
Ethics approval number [9] 679 0
Ethics committee name [10] 680 0
Austin Hospital
Ethics committee address [10] 680 0
Ethics committee country [10] 680 0
Australia
Date submitted for ethics approval [10] 680 0
Approval date [10] 680 0
25/01/1997
Ethics approval number [10] 680 0
Ethics committee name [11] 681 0
Peter MacCallum Cancer Centre
Ethics committee address [11] 681 0
Ethics committee country [11] 681 0
Australia
Date submitted for ethics approval [11] 681 0
Approval date [11] 681 0
17/01/1997
Ethics approval number [11] 681 0
Ethics committee name [12] 682 0
Launceston General Hospital
Ethics committee address [12] 682 0
Ethics committee country [12] 682 0
Australia
Date submitted for ethics approval [12] 682 0
Approval date [12] 682 0
01/10/1996
Ethics approval number [12] 682 0
Ethics committee name [13] 683 0
Sir Charles Gairdner Hospital
Ethics committee address [13] 683 0
Ethics committee country [13] 683 0
Australia
Date submitted for ethics approval [13] 683 0
Approval date [13] 683 0
16/06/1996
Ethics approval number [13] 683 0
Ethics committee name [14] 684 0
Auckland Hospital
Ethics committee address [14] 684 0
Ethics committee country [14] 684 0
New Zealand
Date submitted for ethics approval [14] 684 0
Approval date [14] 684 0
01/08/1996
Ethics approval number [14] 684 0
Ethics committee name [15] 685 0
Christchurch Hospital
Ethics committee address [15] 685 0
Ethics committee country [15] 685 0
New Zealand
Date submitted for ethics approval [15] 685 0
Approval date [15] 685 0
19/07/1997
Ethics approval number [15] 685 0
Ethics committee name [16] 686 0
Dunedin Hospital
Ethics committee address [16] 686 0
Ethics committee country [16] 686 0
New Zealand
Date submitted for ethics approval [16] 686 0
Approval date [16] 686 0
01/03/1997
Ethics approval number [16] 686 0
Ethics committee name [17] 6977 0
Royal Brisbane and Women's Hospital
Ethics committee address [17] 6977 0
Ethics committee country [17] 6977 0
Australia
Date submitted for ethics approval [17] 6977 0
Approval date [17] 6977 0
10/06/1996
Ethics approval number [17] 6977 0
New ethics HREC. Please modify.
Ethics committee name [18] 6978 0
Wellington Hospital
Ethics committee address [18] 6978 0
Ethics committee country [18] 6978 0
New Zealand
Date submitted for ethics approval [18] 6978 0
Approval date [18] 6978 0
13/07/1996
Ethics approval number [18] 6978 0
New ethics HREC. Please modify.

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

Contacts
Principal investigator
Name 27813 0
Prof Jim Denham
Address 27813 0
University of Newcastle
University Drive
Callaghan NSW 2308
Country 27813 0
Australia
Phone 27813 0
+61 2 49854018
Fax 27813 0
Email 27813 0
[email protected]
Contact person for public queries
Name 10899 0
Allison Steigler
Address 10899 0
University of Newcastle
University Drive
Callaghan NSW 2308
Country 10899 0
Australia
Phone 10899 0
+61 2 49854019
Fax 10899 0
Email 10899 0
[email protected]
Contact person for scientific queries
Name 1827 0
Jim Denham
Address 1827 0
University of Newcastle
University Drive
Callaghan NSW 2308
Country 1827 0
Australia
Phone 1827 0
+61 2 49854018
Fax 1827 0
+61 2 49211465
Email 1827 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23129Study protocol  [email protected]



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.