Radiotherapy - Adjuvant Versus Early Salvage
- Conditions
- Prostate Cancer
- Interventions
- Radiation: Adjuvant RadiotherapyRadiation: Early Salvage Radiotherapy
- Registration Number
- NCT00860652
- Lead Sponsor
- Trans Tasman Radiation Oncology Group
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 333
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adjuvant Radiotherapy (RT) Adjuvant Radiotherapy Adjuvant Radiotherapy (64Gy in 32 Fractions to the prostate bed) Active Surveillance with Early SalvageRT Early Salvage Radiotherapy Active Surveillance with Early Salvage Radiotherapy
- Primary Outcome Measures
Name Time Method Biochemical failure: PSA ≥ 0.4 ng/ml and rising following RT After 160 events have been observed, expected to be 5 years after recruitment closes
- Secondary Outcome Measures
Name Time Method Toxicity Final analysis will be after 160 events, estimated to be 5 years after end of accrual. Quality of Life Final Analysis will be after 160 events, estimated to be five years after the end of accrual Overall survival Final analysis will be after 160 events, estimated to be 5 years after end of accrual. Time to distant failure Final analysis will be after 160 events, estimated to be 5 years after end of accrual. Time to the initiation of androgen ablation Final analysis will be after 160 events, estimated to be 5 years after end of accrual. Anxiety/Depression Final analysis will be after 160 events, estimated to be 5 years after end of accrual. Biochemical failure-free survival Final analysis will be after 160 events, estimated to be 5 years after end of accrual. Cost-utility Final analysis will be after 160 events, estimated to be 5 years after end of accrual. Disease-specific survival Final analysis will be after 160 events, estimated to be 5 years after end of accrual. Quality adjusted life years Final analysis will be after 160 events, estimated to be 5 years after end of accrual. Time to local failure Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Trial Locations
- Locations (36)
Campbelltown Hopsital
🇦🇺Campbelltown, New South Wales, Australia
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
St Vincent's Clinic
🇦🇺Darlinghurst, New South Wales, Australia
Nepean Hospital
🇦🇺Kingswood, New South Wales, Australia
St George Hospital
🇦🇺Kogarah, New South Wales, Australia
Port Macquarie Base Hospital, NCCI
🇦🇺Port Macquarie, New South Wales, Australia
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Central West Cancer Services (Orange Health)
🇦🇺Orange, New South Wales, Australia
Calvary Mater Newcastle
🇦🇺Newcastle, New South Wales, Australia
Riverina Cancer Care Centre
🇦🇺Wagga Wagga, New South Wales, Australia
Sydney Adventist Hospital
🇦🇺Wahroonga, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
Radiation Oncology Gold Coast
🇦🇺Gold Coast, Queensland, Australia
Oceania Oncology
🇦🇺Nambour, Queensland, Australia
Radiation Oncology - Mater Centre
🇦🇺South Brisbane, Queensland, Australia
Toowoomba Cancer Research Centre
🇦🇺Toowoomba, Queensland, Australia
Townsville Hospital
🇦🇺Townsville, Queensland, Australia
Premion
🇦🇺Tugun, Queensland, Australia
Austin Hospital
🇦🇺Heidelberg West, Victoria, Australia
The Alfred/WBRC
🇦🇺Melbourne, Victoria, Australia
Fiona Stanley Hospital
🇦🇺Murdoch, Western Australia, Australia
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Perth Radiation Oncology
🇦🇺Perth, Western Australia, Australia
Auckland Radiation Oncology
🇳🇿Epsom, Auckland, New Zealand
Wellington Hospital
🇳🇿Newtown, Wellington, New Zealand
Auckland Hospital
🇳🇿Auckland, New Zealand
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Dunedin Hospital
🇳🇿Dunedin, New Zealand
Palmerston North Hospital
🇳🇿Palmerston North, New Zealand
Radiation Oncology Associates
🇦🇺Darlinghurst, New South Wales, Australia
Peter MacCallum Cancer Centre
🇦🇺East Melbourne, Victoria, Australia
Coffs Harbour Health Campus, NCCI
🇦🇺Coffs Harbour, New South Wales, Australia
Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia