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Radiotherapy - Adjuvant Versus Early Salvage (RAVES)

Primary Purpose

Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Adjuvant Radiotherapy
Early Salvage Radiotherapy
Sponsored by
Trans Tasman Radiation Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Oncology, Prostate Cancer, Radiotherapy, Radical Prostatectomy, Prior Radical Prostatectomy (RP), Histological Confirmation of adenocarcinoma of the prostate, Positive margins and/or extraprostatic extension (EPE)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

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

Sites / Locations

  • Campbelltown Hopsital
  • Royal Prince Alfred Hospital
  • Coffs Harbour Health Campus, NCCI
  • Radiation Oncology Associates
  • St Vincent's Clinic
  • Nepean Hospital
  • St George Hospital
  • Liverpool Hospital
  • Calvary Mater Newcastle
  • Central West Cancer Services (Orange Health)
  • Port Macquarie Base Hospital, NCCI
  • Royal North Shore Hospital
  • Riverina Cancer Care Centre
  • Sydney Adventist Hospital
  • Westmead Hospital
  • Radiation Oncology Gold Coast
  • Royal Brisbane and Women's Hospital
  • Oceania Oncology
  • Radiation Oncology - Mater Centre
  • Toowoomba Cancer Research Centre
  • Townsville Hospital
  • Premion
  • Princess Alexandra Hospital
  • Peter MacCallum Cancer Centre
  • Austin Hospital
  • The Alfred/WBRC
  • Fiona Stanley Hospital
  • Sir Charles Gairdner Hospital
  • Royal Perth Hospital
  • Perth Radiation Oncology
  • Auckland Radiation Oncology
  • Wellington Hospital
  • Auckland Hospital
  • Christchurch Hospital
  • Dunedin Hospital
  • Palmerston North Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Adjuvant Radiotherapy (RT)

Active Surveillance with Early SalvageRT

Arm Description

Adjuvant Radiotherapy (64Gy in 32 Fractions to the prostate bed)

Active Surveillance with Early Salvage Radiotherapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of Life
Toxicity
Anxiety/Depression
Biochemical failure-free survival
Overall survival
Disease-specific survival
Time to distant failure
Time to local failure
Time to the initiation of androgen ablation
Quality adjusted life years
Cost-utility

Full Information

First Posted
March 10, 2009
Last Updated
November 16, 2022
Sponsor
Trans Tasman Radiation Oncology Group
Collaborators
Urological Society of Australia and New Zealand (USANZ), Australian and New Zealand Urogenital and Prostate Cancer Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00860652
Brief Title
Radiotherapy - Adjuvant Versus Early Salvage
Acronym
RAVES
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 3, 2009 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trans Tasman Radiation Oncology Group
Collaborators
Urological Society of Australia and New Zealand (USANZ), Australian and New Zealand Urogenital and Prostate Cancer Trials Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
333 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adjuvant Radiotherapy (RT)
Arm Type
Experimental
Arm Description
Adjuvant Radiotherapy (64Gy in 32 Fractions to the prostate bed)
Arm Title
Active Surveillance with Early SalvageRT
Arm Type
Experimental
Arm Description
Active Surveillance with Early Salvage Radiotherapy
Intervention Type
Radiation
Intervention Name(s)
Adjuvant Radiotherapy
Other Intervention Name(s)
ART, Radiation
Intervention Description
Adjuvant RT (ART) commenced within 4 months of Radical Prostatectomy. 64Gy in 32 fractions to the prostate bed.
Intervention Type
Radiation
Intervention Name(s)
Early Salvage Radiotherapy
Other Intervention Name(s)
SRT, Surveillance, Radiation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Quality of Life
Time Frame
Final Analysis will be after 160 events, estimated to be five years after the end of accrual
Title
Toxicity
Time Frame
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Title
Anxiety/Depression
Time Frame
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Title
Biochemical failure-free survival
Time Frame
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Title
Overall survival
Time Frame
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Title
Disease-specific survival
Time Frame
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Title
Time to distant failure
Time Frame
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Title
Time to local failure
Time Frame
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Title
Time to the initiation of androgen ablation
Time Frame
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Title
Quality adjusted life years
Time Frame
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Title
Cost-utility
Time Frame
Final analysis will be after 160 events, estimated to be 5 years after end of accrual.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Pearse, MBChB
Organizational Affiliation
Trans Tasman Radiation Oncology Group
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andrew Kneebone
Organizational Affiliation
Trans Tasman Radiation Oncology Group
Official's Role
Study Chair
Facility Information:
Facility Name
Campbelltown Hopsital
City
Campbelltown
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Coffs Harbour Health Campus, NCCI
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
Radiation Oncology Associates
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
St Vincent's Clinic
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
1871
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2310
Country
Australia
Facility Name
Central West Cancer Services (Orange Health)
City
Orange
State/Province
New South Wales
Country
Australia
Facility Name
Port Macquarie Base Hospital, NCCI
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Riverina Cancer Care Centre
City
Wagga Wagga
State/Province
New South Wales
ZIP/Postal Code
2650
Country
Australia
Facility Name
Sydney Adventist Hospital
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Radiation Oncology Gold Coast
City
Gold Coast
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Oceania Oncology
City
Nambour
State/Province
Queensland
ZIP/Postal Code
4560
Country
Australia
Facility Name
Radiation Oncology - Mater Centre
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Toowoomba Cancer Research Centre
City
Toowoomba
State/Province
Queensland
ZIP/Postal Code
4350
Country
Australia
Facility Name
Townsville Hospital
City
Townsville
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Facility Name
Premion
City
Tugun
State/Province
Queensland
ZIP/Postal Code
4224
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
The Alfred/WBRC
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Perth Radiation Oncology
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6014
Country
Australia
Facility Name
Auckland Radiation Oncology
City
Epsom
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Wellington Hospital
City
Newtown
State/Province
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Auckland Hospital
City
Auckland
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Palmerston North Hospital
City
Palmerston North
ZIP/Postal Code
4414
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
33002437
Citation
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.
Results Reference
derived
Links:
URL
http://www.trog.com.au
Description
Trans Tasman Radiation Oncology Group

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Radiotherapy - Adjuvant Versus Early Salvage

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