Radiotherapy - Adjuvant Versus Early Salvage
RAVES
1 other identifier
interventional
333
2 countries
36
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Mar 2009
Longer than P75 for not_applicable prostate-cancer
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 3, 2009
CompletedFirst Submitted
Initial submission to the registry
March 10, 2009
CompletedFirst Posted
Study publicly available on registry
March 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedNovember 18, 2022
November 1, 2022
13.8 years
March 10, 2009
November 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biochemical failure: PSA ≥ 0.4 ng/ml and rising following RT
After 160 events have been observed, expected to be 5 years after recruitment closes
Secondary Outcomes (11)
Quality of Life
Final Analysis will be after 160 events, estimated to be five years after the end of accrual
Toxicity
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Anxiety/Depression
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Biochemical failure-free survival
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Overall survival
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
- +6 more secondary outcomes
Study Arms (2)
Adjuvant Radiotherapy (RT)
EXPERIMENTALAdjuvant Radiotherapy (64Gy in 32 Fractions to the prostate bed)
Active Surveillance with Early SalvageRT
EXPERIMENTALActive Surveillance with Early Salvage Radiotherapy
Interventions
Adjuvant RT (ART) commenced within 4 months of Radical Prostatectomy. 64Gy in 32 fractions to the prostate bed.
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.
Eligibility Criteria
You may qualify if:
- 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
- years and older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Campbelltown Hopsital
Campbelltown, New South Wales, 2170, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Coffs Harbour Health Campus, NCCI
Coffs Harbour, New South Wales, 2450, Australia
Radiation Oncology Associates
Darlinghurst, New South Wales, 2010, Australia
St Vincent's Clinic
Darlinghurst, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
Liverpool Hospital
Liverpool, New South Wales, 1871, Australia
Calvary Mater Newcastle
Newcastle, New South Wales, 2310, Australia
Central West Cancer Services (Orange Health)
Orange, New South Wales, Australia
Port Macquarie Base Hospital, NCCI
Port Macquarie, New South Wales, 2444, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Riverina Cancer Care Centre
Wagga Wagga, New South Wales, 2650, Australia
Sydney Adventist Hospital
Wahroonga, New South Wales, 2076, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Radiation Oncology Gold Coast
Gold Coast, Queensland, 4217, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Oceania Oncology
Nambour, Queensland, 4560, Australia
Radiation Oncology - Mater Centre
South Brisbane, Queensland, 4101, Australia
Toowoomba Cancer Research Centre
Toowoomba, Queensland, 4350, Australia
Townsville Hospital
Townsville, Queensland, 4814, Australia
Premion
Tugun, Queensland, 4224, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002, Australia
Austin Hospital
Heidelberg West, Victoria, 3081, Australia
The Alfred/WBRC
Melbourne, Victoria, 3004, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Perth Radiation Oncology
Perth, Western Australia, 6014, Australia
Auckland Radiation Oncology
Epsom, Auckland, 1023, New Zealand
Wellington Hospital
Newtown, Wellington Region, 6021, New Zealand
Auckland Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Dunedin Hospital
Dunedin, 9016, New Zealand
Palmerston North Hospital
Palmerston North, 4414, New Zealand
Related Publications (1)
Kneebone A, Fraser-Browne C, Duchesne GM, Fisher R, Frydenberg M, Herschtal A, Williams SG, Brown C, Delprado W, Haworth A, Joseph DJ, Martin JM, Matthews JHL, Millar JL, Sidhom M, Spry N, Tang CI, Turner S, Wiltshire KL, Woo HH, Davis ID, Lim TS, Pearse M. Adjuvant radiotherapy versus early salvage radiotherapy following radical prostatectomy (TROG 08.03/ANZUP RAVES): a randomised, controlled, phase 3, non-inferiority trial. Lancet Oncol. 2020 Oct;21(10):1331-1340. doi: 10.1016/S1470-2045(20)30456-3.
PMID: 33002437DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Maria Pearse, MBChB
Trans Tasman Radiation Oncology Group
- STUDY CHAIR
Andrew Kneebone
Trans Tasman Radiation Oncology Group
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2009
First Posted
March 12, 2009
Study Start
March 3, 2009
Primary Completion
December 1, 2022
Study Completion (Estimated)
December 1, 2026
Last Updated
November 18, 2022
Record last verified: 2022-11