Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00860652




Registration number
NCT00860652
Ethics application status
Date submitted
10/03/2009
Date registered
12/03/2009
Date last updated
18/11/2022

Titles & IDs
Public title
Radiotherapy - Adjuvant Versus Early Salvage
Scientific title
Radiotherapy - Adjuvant Versus Early Salvage. A Phase III Multi-centre Randomised Trial Comparing Adjuvant Radiotherapy (RT) With Early Salvage RT in Patients With Positive Margins or Extraprostatic Disease Following Radical Prostatectomy.
Secondary ID [1] 0 0
TROG 08.03
Universal Trial Number (UTN)
Trial acronym
RAVES
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Adjuvant Radiotherapy
Treatment: Other - Early Salvage Radiotherapy

Experimental: Adjuvant Radiotherapy (RT) - Adjuvant Radiotherapy (64Gy in 32 Fractions to the prostate bed)

Experimental: Active Surveillance with Early SalvageRT - Active Surveillance with Early Salvage Radiotherapy


Treatment: Other: Adjuvant Radiotherapy
Adjuvant RT (ART) commenced within 4 months of Radical Prostatectomy. 64Gy in 32 fractions to the prostate bed.

Treatment: Other: Early Salvage Radiotherapy
Active surveillance with early Salvage RT (SRT). SRT - 64Gy in 32 fractions to the prostate bed. RT should commence no later than 4 months following the first PSA measurement = 0.2ng/mL.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Biochemical failure: PSA = 0.4 ng/ml and rising following RT
Timepoint [1] 0 0
After 160 events have been observed, expected to be 5 years after recruitment closes
Secondary outcome [1] 0 0
Quality of Life
Timepoint [1] 0 0
Final Analysis will be after 160 events, estimated to be five years after the end of accrual
Secondary outcome [2] 0 0
Toxicity
Timepoint [2] 0 0
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Secondary outcome [3] 0 0
Anxiety/Depression
Timepoint [3] 0 0
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Secondary outcome [4] 0 0
Biochemical failure-free survival
Timepoint [4] 0 0
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Secondary outcome [5] 0 0
Overall survival
Timepoint [5] 0 0
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Secondary outcome [6] 0 0
Disease-specific survival
Timepoint [6] 0 0
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Secondary outcome [7] 0 0
Time to distant failure
Timepoint [7] 0 0
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Secondary outcome [8] 0 0
Time to local failure
Timepoint [8] 0 0
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Secondary outcome [9] 0 0
Time to the initiation of androgen ablation
Timepoint [9] 0 0
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Secondary outcome [10] 0 0
Quality adjusted life years
Timepoint [10] 0 0
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Secondary outcome [11] 0 0
Cost-utility
Timepoint [11] 0 0
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.

Eligibility
Key inclusion criteria
* Prior Radical Prostatectomy (RP) for adenocarcinoma of the prostate.
* Histological confirmation of adenocarcinoma of the prostate with the Gleason score reported (Radical Prostatectomy specimen).
* Patients must have at least one of the following risk factors: 1) Positive margins, 2) Extraprostatic extension (EPE) with or without seminal vesicle involvement (pT3a or pT3b)
* Capable of starting RT within 4 months of RP (a requirement if randomised to adjuvant RT arm)
* Most recent PSA = 0.10 ng/ml following RP and prior to randomisation
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
* Patient able to adhere to the specified follow-up schedule and complete the Quality of Life and anxiety/depression self-assessments
* Written informed consent obtained prior to randomisation
* Completion of all pre-treatment evaluations
* 18 years and older
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous pelvic RT
* Androgen deprivation (AD) prior to or following RP
* Evidence of nodal or distant metastases
* Co-morbidities that would interfere with the completion of treatment and/or 5 years of follow-up
* Concurrent cytotoxic medication
* Hip prosthesis

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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/03/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
Accrual to date
Final
333
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Campbelltown Hopsital - Campbelltown
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Coffs Harbour Health Campus, NCCI - Coffs Harbour
Recruitment hospital [4] 0 0
Radiation Oncology Associates - Darlinghurst
Recruitment hospital [5] 0 0
St Vincent's Clinic - Darlinghurst
Recruitment hospital [6] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [7] 0 0
St George Hospital - Kogarah
Recruitment hospital [8] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [9] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [10] 0 0
Central West Cancer Services (Orange Health) - Orange
Recruitment hospital [11] 0 0
Port Macquarie Base Hospital, NCCI - Port Macquarie
Recruitment hospital [12] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [13] 0 0
Riverina Cancer Care Centre - Wagga Wagga
Recruitment hospital [14] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [15] 0 0
Westmead Hospital - Westmead
Recruitment hospital [16] 0 0
Radiation Oncology Gold Coast - Gold Coast
Recruitment hospital [17] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [18] 0 0
Oceania Oncology - Nambour
Recruitment hospital [19] 0 0
Radiation Oncology - Mater Centre - South Brisbane
Recruitment hospital [20] 0 0
Toowoomba Cancer Research Centre - Toowoomba
Recruitment hospital [21] 0 0
Townsville Hospital - Townsville
Recruitment hospital [22] 0 0
Premion - Tugun
Recruitment hospital [23] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [24] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [25] 0 0
Austin Hospital - Heidelberg West
Recruitment hospital [26] 0 0
The Alfred/WBRC - Melbourne
Recruitment hospital [27] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [28] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [29] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [30] 0 0
Perth Radiation Oncology - Perth
Recruitment postcode(s) [1] 0 0
2170 - Campbelltown
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [4] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [5] 0 0
- Darlinghurst
Recruitment postcode(s) [6] 0 0
2747 - Kingswood
Recruitment postcode(s) [7] 0 0
2217 - Kogarah
Recruitment postcode(s) [8] 0 0
1871 - Liverpool
Recruitment postcode(s) [9] 0 0
2310 - Newcastle
Recruitment postcode(s) [10] 0 0
- Orange
Recruitment postcode(s) [11] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [12] 0 0
2065 - St Leonards
Recruitment postcode(s) [13] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [14] 0 0
2076 - Wahroonga
Recruitment postcode(s) [15] 0 0
2145 - Westmead
Recruitment postcode(s) [16] 0 0
4217 - Gold Coast
Recruitment postcode(s) [17] 0 0
4029 - Herston
Recruitment postcode(s) [18] 0 0
4560 - Nambour
Recruitment postcode(s) [19] 0 0
4101 - South Brisbane
Recruitment postcode(s) [20] 0 0
4350 - Toowoomba
Recruitment postcode(s) [21] 0 0
4814 - Townsville
Recruitment postcode(s) [22] 0 0
4224 - Tugun
Recruitment postcode(s) [23] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [24] 0 0
3002 - East Melbourne
Recruitment postcode(s) [25] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [26] 0 0
3004 - Melbourne
Recruitment postcode(s) [27] 0 0
6150 - Murdoch
Recruitment postcode(s) [28] 0 0
6009 - Nedlands
Recruitment postcode(s) [29] 0 0
6000 - Perth
Recruitment postcode(s) [30] 0 0
6014 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Wellington
Country [3] 0 0
New Zealand
State/province [3] 0 0
Christchurch
Country [4] 0 0
New Zealand
State/province [4] 0 0
Dunedin
Country [5] 0 0
New Zealand
State/province [5] 0 0
Palmerston North

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Urological Society of Australia and New Zealand (USANZ)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Maria Pearse, MBChB
Address 0 0
Trans Tasman Radiation Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00860652