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Radiotherapy - Adjuvant Versus Early Salvage (RAVES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00860652
Recruitment Status : Active, not recruiting
First Posted : March 12, 2009
Last Update Posted : March 13, 2020
Sponsor:
Collaborators:
Urological Society of Australia and New Zealand (USANZ)
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Information provided by (Responsible Party):
Trans Tasman Radiation Oncology Group

Tracking Information
First Submitted Date  ICMJE March 10, 2009
First Posted Date  ICMJE March 12, 2009
Last Update Posted Date March 13, 2020
Actual Study Start Date  ICMJE March 3, 2009
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2009)
  • Quality of Life [ Time Frame: Final Analysis will be after 160 events, estimated to be five years after the end of accrual ]
  • Toxicity [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ]
  • Anxiety/Depression [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ]
  • Biochemical failure-free survival [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ]
  • Overall survival [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ]
  • Disease-specific survival [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ]
  • Time to distant failure [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ]
  • Time to local failure [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ]
  • 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. ]
  • Quality adjusted life years [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ]
  • Cost-utility [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiotherapy - Adjuvant Versus Early Salvage
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Radiation: Adjuvant Radiotherapy
    Adjuvant RT (ART) commenced within 4 months of Radical Prostatectomy. 64Gy in 32 fractions to the prostate bed.
    Other Name: ART, Radiation
  • Radiation: 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.
    Other Name: SRT, Surveillance, Radiation
Study Arms  ICMJE
  • Experimental: Adjuvant Radiotherapy (RT)
    Adjuvant Radiotherapy (64Gy in 32 Fractions to the prostate bed)
    Intervention: Radiation: Adjuvant Radiotherapy
  • Experimental: Active Surveillance with Early SalvageRT
    Active Surveillance with Early Salvage Radiotherapy
    Intervention: Radiation: Early Salvage Radiotherapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 18, 2016)
333
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2009)
470
Estimated Study Completion Date  ICMJE December 2026
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00860652
Other Study ID Numbers  ICMJE TROG 08.03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Trans Tasman Radiation Oncology Group
Study Sponsor  ICMJE Trans Tasman Radiation Oncology Group
Collaborators  ICMJE
  • Urological Society of Australia and New Zealand (USANZ)
  • Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Investigators  ICMJE
Study Chair: Maria Pearse, MBChB Trans Tasman Radiation Oncology Group
Study Chair: Andrew Kneebone Trans Tasman Radiation Oncology Group
PRS Account Trans Tasman Radiation Oncology Group
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP