Radiotherapy - Adjuvant Versus Early Salvage (RAVES)

This study is ongoing, but not recruiting participants.
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 (TROG)
ClinicalTrials.gov Identifier:
NCT00860652
First received: March 10, 2009
Last updated: January 18, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention Phase
Prostate Cancer
Radiation: Adjuvant Radiotherapy
Radiation: Early Salvage Radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Final Analysis will be after 160 events, estimated to be five years after the end of accrual ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ] [ Designated as safety issue: Yes ]
  • Anxiety/Depression [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ] [ Designated as safety issue: No ]
  • Biochemical failure-free survival [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ] [ Designated as safety issue: No ]
  • Disease-specific survival [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ] [ Designated as safety issue: No ]
  • Time to distant failure [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ] [ Designated as safety issue: No ]
  • Time to local failure [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Quality adjusted life years [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ] [ Designated as safety issue: No ]
  • Cost-utility [ Time Frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual. ] [ Designated as safety issue: No ]

Enrollment: 333
Study Start Date: March 2009
Estimated Study Completion Date: December 2026
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adjuvant Radiotherapy (RT)
Adjuvant Radiotherapy (64Gy in 32 Fractions to the prostate bed)
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
Experimental: Active Surveillance with Early SalvageRT
Active Surveillance with Early Salvage Radiotherapy
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860652

Locations
Australia, New South Wales
Campbelltown Hopsital
Campbelltown, New South Wales, Australia, 2170
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Coffs Harbour Health Campus, NCCI
Coffs Harbour, New South Wales, Australia, 2450
St Vincent's Clinic
Darlinghurst, New South Wales, Australia
Radiation Oncology Associates
Darlinghurst, New South Wales, Australia, 2010
Nepean Hospital
Kingswood, New South Wales, Australia, 2747
St George Hospital
Kogarah, New South Wales, Australia, 2217
Liverpool Hospital
Liverpool, New South Wales, Australia, 1871
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2310
Central West Cancer Services (Orange Health)
Orange, New South Wales, Australia
Port Macquarie Base Hospital, NCCI
Port Macquarie, New South Wales, Australia, 2444
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Riverina Cancer Care Centre
Wagga Wagga, New South Wales, Australia, 2650
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia, 2076
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Radiation Oncology Gold Coast
Gold Coast, Queensland, Australia, 4217
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Oceania Oncology
Nambour, Queensland, Australia, 4560
Radiation Oncology - Mater Centre
South Brisbane, Queensland, Australia, 4101
Toowoomba Cancer Research Centre
Toowoomba, Queensland, Australia, 4350
Townsville Hospital
Townsville, Queensland, Australia, 4814
Premion
Tugun, Queensland, Australia, 4224
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Austin Hospital
Heidelberg West, Victoria, Australia, 3081
The Alfred/WBRC
Prahan, Victoria, Australia, 3181
Australia, Western Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Perth Radiation Oncology
Perth, Western Australia, Australia, 6014
New Zealand
Auckland Radiation Oncology
Epsom, Auckland, New Zealand, 1023
Wellington Hospital
Newtown, Wellington, New Zealand, 6021
Auckland Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Dunedin Hospital
Dunedin, New Zealand, 9016
Palmerston North Hospital
Palmerston North, New Zealand, 4414
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Urological Society of Australia and New Zealand (USANZ)
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Investigators
Study Chair: Maria Pearse, MBChB Trans-Tasman Radiation Oncology Group (TROG)
Study Chair: Andrew Kneebone Trans-Tasman Radiation Oncology Group (TROG)
  More Information

Additional Information:
Responsible Party: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT00860652     History of Changes
Other Study ID Numbers: TROG 08.03 
Study First Received: March 10, 2009
Last Updated: January 18, 2016
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Oncology
Prostate Cancer
Radiotherapy
Radical Prostatectomy
Prior Radical Prostatectomy (RP)
Histological Confirmation of adenocarcinoma of the prostate
Positive margins and/or extraprostatic extension (EPE)

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 21, 2016