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Radiotherapy - Adjuvant Versus Early Salvage
Sponsor: Trans Tasman Radiation Oncology Group
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.
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.
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
333
Start Date
2009-03-03
Completion Date
2026-12
Last Updated
2022-11-18
Healthy Volunteers
No
Conditions
Interventions
Adjuvant Radiotherapy
Adjuvant RT (ART) commenced within 4 months of Radical Prostatectomy. 64Gy in 32 fractions to the prostate bed.
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.
Locations (36)
Campbelltown Hopsital
Campbelltown, New South Wales, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Coffs Harbour Health Campus, NCCI
Coffs Harbour, New South Wales, Australia
Radiation Oncology Associates
Darlinghurst, 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
Liverpool Hospital
Liverpool, New South Wales, Australia
Calvary Mater Newcastle
Newcastle, New South Wales, Australia
Central West Cancer Services (Orange Health)
Orange, New South Wales, Australia
Port Macquarie Base Hospital, NCCI
Port Macquarie, New South Wales, Australia
Royal North Shore Hospital
St Leonards, 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
Radiation Oncology Gold Coast
Gold Coast, Queensland, Australia
Royal Brisbane and Women's Hospital
Herston, 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
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
Austin Hospital
Heidelberg West, Victoria, Australia
The Alfred/WBRC
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Perth Radiation Oncology
Perth, Western Australia, Australia
Auckland Radiation Oncology
Epsom, Auckland, New Zealand
Wellington Hospital
Newtown, Wellington Region, New Zealand
Auckland Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Dunedin Hospital
Dunedin, New Zealand
Palmerston North Hospital
Palmerston North, New Zealand