Radiotherapy - Adjuvant Versus Early Salvage (RAVES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Trans-Tasman Radiation Oncology Group (TROG)
Sponsor:
Collaborators:
Urological Society of Australia and New Zealand (USANZ)
Australian & New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00860652
First received: March 10, 2009
Last updated: February 13, 2013
Last verified: February 2013
  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 ]

Estimated Enrollment: 470
Study Start Date: March 2009
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2019 (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
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

Contacts
Contact: Carol Fraser-Browne +64 9 307 4949 ext 23044 carolFB@adhb.govt.nz

Locations
Australia, New South Wales
Campbelltown Hopsital Recruiting
Campbelltown, New South Wales, Australia, 2170
Contact: Mark Sidhom       Mark.Sidhom@sswahs.nsw.gov.au   
Principal Investigator: Mark Sidolm         
Royal Prince Alfred Hospital Recruiting
Camperdown, New South Wales, Australia, 2050
Contact: George Hruby       ghruby@email.cs.nsw.gov.au   
Principal Investigator: George Hruby         
Coffs Harbour Health Campus, NCCI Active, not recruiting
Coffs Harbour, New South Wales, Australia, 2450
Radiation Oncology Associates Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Gerald Fogarty         
Principal Investigator: Gerald Fogarty         
Nepean Hospital Recruiting
Kingswood, New South Wales, Australia, 2747
Contact: Do Viet       Viet.Do@swahs.health.nsw.gov.au   
Principal Investigator: Viet Do         
St George Hospital Recruiting
Kogarah, New South Wales, Australia, 2217
Contact: Joseph Bucci       Joseph.Bucci@SESIAHS.HEALTH.NSW.GOV.AU   
Principal Investigator: J Bucci         
Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia, 1871
Contact: Mark Sidhom       Mark.Sidhom@sswahs.nsw.gov.au   
Principal Investigator: Mark Sidhom         
Calvary Mater Newcastle Recruiting
Newcastle, New South Wales, Australia, 2310
Contact: Anne Capp       anne.capp@mater.health.nsw.gov.au   
Principal Investigator: Colin Tang         
Port Macquarie Base Hospital, NCCI Recruiting
Port Macquarie, New South Wales, Australia, 2444
Contact: Tom Shakespeare       Thomas.Shakespeare@ncahs.health.nsw.gov.au   
Principal Investigator: Tom Shakespeare         
Royal North Shore Hospital Recruiting
St Leonards, New South Wales, Australia, 2065
Contact: Andrew Kneebone    +61 2 9926 7483    AKneebone@nsccahs.health.nsw.gov.au   
Principal Investigator: Andrew Kneebone         
Riverina Cancer Care Centre Recruiting
Wagga Wagga, New South Wales, Australia, 2650
Contact: Kandeepan Thursiaingam       kthuraisingam@cancercare.com.au   
Principal Investigator: K Thuraisingam         
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Sandra Turner       sandra.turner@swahs.health.nsw.gov.au   
Principal Investigator: Sandra Turner         
Illawarra Cancer Care Centre Withdrawn
Wooloongong, New South Wales, Australia, 2500
Australia, Queensland
Royal Brisbane and Women's Hospital Recruiting
Herston, Queensland, Australia, 4029
Contact: Charles Lin       Charles_Lin@health.qld.gov.au   
Principal Investigator: C Lin         
Radiation Oncology - Mater Centre Recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Liz Kenny       lizkenny@bigpond.net.au   
Principal Investigator: Liz Kenny         
Toowoomba Cancer Research Centre Recruiting
Toowoomba, Queensland, Australia, 4350
Contact: Eric Khoo       Eric.Khoo@roq.net.au   
Principal Investigator: Khoo Eric         
Townsville Hospital Recruiting
Townsville, Queensland, Australia, 4814
Contact: Alex Tan       alextan75@gmail.com   
Principal Investigator: Alex Tan         
Premion Recruiting
Tugan, Queensland, Australia, 4224
Contact: David Christie       David.Christie@premion.com.au   
Principal Investigator: David Christie         
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Contact: Margot Lehman       margot_lehman@health.qld.gov.au   
Principal Investigator: Margot Lehman         
Australia, Tasmania
Royal Hobart Hospital Recruiting
Hobart, Tasmania, Australia, 7000
Contact: Marketa Skala       marketa.skala@dhhs.tas.gov.au   
Principal Investigator: Marketa Skala         
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
East Melbourne, Victoria, Australia, 3002
Contact: Scott Williams       Scott.Williams@petermac.org   
Principal Investigator: Scott Williams         
Austin Hospital Recruiting
Heidelberg West, Victoria, Australia, 3081
Contact: Daryl Limjoon       Daryl.LIMJOON@austin.org.au   
Principal Investigator: Darryl Limjoon         
The Alfred/WBRC Recruiting
Prahan, Victoria, Australia, 3181
Contact: Bronwyn Matheson       bronwyn.matheson@wbrc.org.au   
Principal Investigator: B Matheson         
Australia, Western Australia
Sir Charles Gardiner Hospital Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Nigel Spry       Nigel.Spry@health.wa.gov.au   
Contact: David Joseph         
Principal Investigator: Nigel Spry         
Sub-Investigator: David Joseph         
Perth Radiation Oncology Recruiting
Perth, Western Australia, Australia, 6014
Contact: Serena Sia       Ssia@iinet.net.au   
Principal Investigator: Serena Sia         
Royal Perth Hospital Recruiting
Perth, Western Australia, Australia, 6000
Contact: Serena Sia       Ssia@iinet.net.au   
Principal Investigator: Serena Sia         
New Zealand
Wellington Hospital Recruiting
Newtown, Wellington, New Zealand, 6021
Contact: Douglas Iupati       Douglas.Iupati@ccdhb.org.nz   
Principal Investigator: D Lupati         
Auckland Hospital Recruiting
Auckland, New Zealand
Contact: Maria Pearse, MBChB    +64 09 307 4949    mariap@adhb.govt.nz   
Principal Investigator: Maria Pearse, MBChB         
Christchurch Hospital Recruiting
Christchurch, New Zealand
Contact: Steve Williams       Stephen.Williams@cdhb.govt.nz   
Principal Investigator: S Williams         
Dunedin Hospital Recruiting
Dunedin, New Zealand, 9016
Contact: John North       johnn@healthotago.co.nz   
Principal Investigator: John North         
Palmerston North Hospital Recruiting
Palmerston North, New Zealand, 4414
Contact: Donald Chan       Donald.Chan@midcentraldhb.govt.nz   
Principal Investigator: Donald Chan         
Waikato Hospital Recruiting
Waikato, New Zealand, 3240
Contact: Leanne Tyrie       TyrieL@waikatodhb.govt.nz   
Principal Investigator: Leanne Tyrie         
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Urological Society of Australia and New Zealand (USANZ)
Australian & New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)
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:
No publications provided

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: February 13, 2013
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 22, 2014