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Prostate CancerRAVESNCT00860652

Radiotherapy - Adjuvant Versus Early Salvage

A study testing Adjuvant Radiotherapy and Early Salvage Radiotherapy in people with Prostate Cancer, run by Trans Tasman Radiation Oncology Group at 36 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Adjuvant Radiotherapy and Early Salvage Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
333 participants
Where
36 sitesin 2 countries
Study dates
3 Mar 2009to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

36 sites in 2 countries.

36 sites in 2 countries

Australia30 sites

  • Campbelltown Hopsital

    Campbelltown, New South Wales, 2170

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Coffs Harbour Health Campus, NCCI

    Coffs Harbour, New South Wales, 2450

  • Radiation Oncology Associates

    Darlinghurst, New South Wales, 2010

  • St Vincent's Clinic

    Darlinghurst, New South Wales

  • Peter MacCallum Cancer Centre

    East Melbourne, Victoria, 3002

  • Radiation Oncology Gold Coast

    Gold Coast, Queensland, 4217

  • Austin Hospital

    Heidelberg West, Victoria, 3081

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • St George Hospital

    Kogarah, New South Wales, 2217

  • Liverpool Hospital

    Liverpool, New South Wales, 1871

  • The Alfred/WBRC

    Melbourne, Victoria, 3004

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Oceania Oncology

    Nambour, Queensland, 4560

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Calvary Mater Newcastle

    Newcastle, New South Wales, 2310

  • Central West Cancer Services (Orange Health)

    Orange, New South Wales

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Perth Radiation Oncology

    Perth, Western Australia, 6014

  • Port Macquarie Base Hospital, NCCI

    Port Macquarie, New South Wales, 2444

  • Radiation Oncology - Mater Centre

    South Brisbane, Queensland, 4101

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Toowoomba Cancer Research Centre

    Toowoomba, Queensland, 4350

  • Townsville Hospital

    Townsville, Queensland, 4814

  • Premion

    Tugun, Queensland, 4224

  • Riverina Cancer Care Centre

    Wagga Wagga, New South Wales, 2650

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

New Zealand6 sites

  • Auckland Hospital

    Auckland

  • Christchurch Hospital

    Christchurch

  • Dunedin Hospital

    Dunedin, 9016

  • Auckland Radiation Oncology

    Epsom, Auckland, 1023

  • Wellington Hospital

    Newtown, Wellington Region, 6021

  • Palmerston North Hospital

    Palmerston North, 4414

Other trials in New Zealand

About this study

Official 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.

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.

Read the detailed description

This is a prospective, multi-centre, international, randomised controlled trial with a 1:1 allocation ratio. Patients with positive margins and/or pT3 disease will be randomised to adjuvant RT (Standard Arm) or active surveillance with salvage RT delivered at early relapse (Experimental Arm). 64 Gy in 32 fractions will be delivered to the prostate bed. QoL self-assessment questionnaires, Hospital Anxiety and Depression Score and toxicity will be assessed at baseline, the end of RT and annually for 5 years. Patients will be seen by their doctor 6 monthly for the first 5 years, then annually for the next 5 years. A blood test measuring prostate specific antigen (PSA) is done 3 monthly for the first 5 years for patients randomised to early salvage RT, then 6 monthly from years 5 to 10.

Conditions
Prostate Cancer
Being tested
Adjuvant Radiotherapy, Early Salvage Radiotherapy
Keywords
Oncology, Prostate Cancer, Radiotherapy, Radical Prostatectomy, Prior Radical Prostatectomy (RP), Histological Confirmation of adenocarcinoma of the prostate, Positive margins and/or extraprostatic extension (EPE)
Medical subject headings
Prostatic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adjuvant RadiotherapyRadiation

    Also called ART, Radiation

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

  • Early Salvage RadiotherapyRadiation

    Also called SRT, Surveillance, Radiation

    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.

Study groups in NCT00860652
Study groupRoleWhat they receive
Adjuvant Radiotherapy (RT)ExperimentalAdjuvant Radiotherapy (64Gy in 32 Fractions to the prostate bed)
Receives: Radiation: Adjuvant Radiotherapy
Active Surveillance with Early SalvageRTExperimentalActive Surveillance with Early Salvage Radiotherapy
Receives: Radiation: Early Salvage Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemical failure: PSA ≥ 0.4 ng/ml and rising following RT

    Measured: After 160 events have been observed, expected to be 5 years after recruitment closes

Secondary outcomes (11)

  1. Quality of Life

    Measured: Final Analysis will be after 160 events, estimated to be five years after the end of accrual

  2. Toxicity

    Measured: Final analysis will be after 160 events, estimated to be 5 years after end of accrual.

  3. Anxiety/Depression

    Measured: Final analysis will be after 160 events, estimated to be 5 years after end of accrual.

  4. Biochemical failure-free survival

    Measured: Final analysis will be after 160 events, estimated to be 5 years after end of accrual.

  5. Overall survival

    Measured: Final analysis will be after 160 events, estimated to be 5 years after end of accrual.

  6. Disease-specific survival

    Measured: Final analysis will be after 160 events, estimated to be 5 years after end of accrual.

  7. Time to distant failure

    Measured: Final analysis will be after 160 events, estimated to be 5 years after end of accrual.

  8. Time to local failure

    Measured: Final analysis will be after 160 events, estimated to be 5 years after end of accrual.

  9. Time to the initiation of androgen ablation

    Measured: Final analysis will be after 160 events, estimated to be 5 years after end of accrual.

  10. Quality adjusted life years

    Measured: Final analysis will be after 160 events, estimated to be 5 years after end of accrual.

  11. Cost-utility

    Measured: Final analysis will be after 160 events, estimated to be 5 years after end of accrual.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2009 (estimated)
  2. Study start3 Mar 2009
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
333 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00860652
Sponsor's protocol ID
TROG 08.03
Acronym
RAVES
Status last verified
Nov 2022
First submitted
10 Mar 2009
Last updated
18 Nov 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33002437

Questions about this trial

What is this clinical trial studying?

A study testing Adjuvant Radiotherapy and Early Salvage Radiotherapy in people with Prostate Cancer, run by Trans Tasman Radiation Oncology Group at 36 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemical failure: PSA ≥ 0.4 ng/ml and rising following RT (time frame: After 160 events have been observed, expected to be 5 years after recruitment closes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00860652, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022; AzTrials last refreshed its copy on 30 Oct 2026.

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