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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00860652
Ethics application status
Date submitted
10/03/2009
Date registered
11/03/2009
Date last updated
10/07/2017

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
Gender
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
Phase 3
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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 - Prahan
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
3181 - Prahan
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 (TROG)
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
Radical prostatectomy (RP) is the most common curative approach offered to men with newly
diagnosed prostate cancer. Unfortunately, up to half of these patients will have factors
placing them at high risk of their cancer recurring. Having radiotherapy after RP is known to
improve cure rates, but what is not known is whether it should be given straight after the
operation or only when there is a rising PSA after surgery indicating active cancer.
Immediate RT may not benefit all men, and can cause serious side effects such as bladder and
bowel problems and impotence. International lack of consensus on the optimal timing of RT has
resulted in varied clinical practice. This phase 3 trial will compare the two approaches.
Trial website
https://clinicaltrials.gov/show/NCT00860652
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Maria Pearse, MBChB
Address 0 0
Trans-Tasman Radiation Oncology Group (TROG)
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

Summary results
Other publications