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Radiotherapy - Adjuvant Versus Early Salvage (RAVES)

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ClinicalTrials.gov Identifier: NCT00860652
Recruitment Status : Active, not recruiting
First Posted : March 12, 2009
Last Update Posted : July 12, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

March 10, 2009
March 12, 2009
July 12, 2017
March 2009
December 2021   (Final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00860652 on ClinicalTrials.gov Archive Site
  • 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. ]
Same as current
Not Provided
Not Provided
 
Radiotherapy - Adjuvant Versus Early Salvage
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
333
December 2026
December 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   New Zealand
 
 
NCT00860652
TROG 08.03
Yes
Not Provided
Not Provided
Trans-Tasman Radiation Oncology Group (TROG)
Trans-Tasman Radiation Oncology Group (TROG)
  • Urological Society of Australia and New Zealand (USANZ)
  • Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Study Chair: Maria Pearse, MBChB Trans-Tasman Radiation Oncology Group (TROG)
Study Chair: Andrew Kneebone Trans-Tasman Radiation Oncology Group (TROG)
Trans-Tasman Radiation Oncology Group (TROG)
July 2017

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