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ACTIVE NOT RECRUITING
NCT00860652
NA

Radiotherapy - Adjuvant Versus Early Salvage

Sponsor: Trans Tasman Radiation Oncology Group

View on ClinicalTrials.gov

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

RADIATION

Adjuvant Radiotherapy

Adjuvant RT (ART) commenced within 4 months of Radical Prostatectomy. 64Gy in 32 fractions to the prostate bed.

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.

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