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NCT00860652Active, not recruiting

Radiotherapy - Adjuvant Versus Early Salvage

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.

Source: ClinicalTrials.gov · Last updated 18 Nov 2022

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
333 (actual)
First submitted
10 Mar 2009
Start date
3 Mar 2009
Primary completion date
31 Dec 2022
Lead sponsor
Trans Tasman Radiation Oncology Group
NCT number
NCT00860652

What you commit to

  • Study type: Interventional
  • Participants enrolled: 333
  • From 3 Mar 2009 to the primary completion date, 31 Dec 2022
  • 36 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous pelvic RT
  • Androgen deprivation (AD) prior to or following RP
  • Concurrent cytotoxic medication

Other

  • Evidence of nodal or distant metastases
  • Co-morbidities that would interfere with the completion of treatment and/or 5 years of follow-up
  • Hip prosthesis

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (36)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Campbelltown Hopsital
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CampbelltownAustraliaUnknown status
Royal Prince Alfred Hospital
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CamperdownAustraliaUnknown status
Coffs Harbour Health Campus, NCCI
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Coffs HarbourAustraliaUnknown status
Radiation Oncology Associates
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DarlinghurstAustraliaUnknown status
St Vincent's Clinic
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DarlinghurstAustraliaUnknown status
Peter MacCallum Cancer Centre
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East MelbourneAustraliaUnknown status
Radiation Oncology Gold Coast
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Gold CoastAustraliaUnknown status
Austin Hospital
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Heidelberg WestAustraliaUnknown status
Royal Brisbane and Women's Hospital
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HerstonAustraliaUnknown status
Nepean Hospital
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KingswoodAustraliaUnknown status
St George Hospital
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KogarahAustraliaUnknown status
Liverpool Hospital
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LiverpoolAustraliaUnknown status
The Alfred/WBRC
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MelbourneAustraliaUnknown status
Fiona Stanley Hospital
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MurdochAustraliaUnknown status
Oceania Oncology
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NambourAustraliaUnknown status
Sir Charles Gairdner Hospital
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NedlandsAustraliaUnknown status
Calvary Mater Newcastle
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NewcastleAustraliaUnknown status
Central West Cancer Services (Orange Health)
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OrangeAustraliaUnknown status
Royal Perth Hospital
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PerthAustraliaUnknown status
Perth Radiation Oncology
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PerthAustraliaUnknown status
Port Macquarie Base Hospital, NCCI
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Port MacquarieAustraliaUnknown status
Radiation Oncology - Mater Centre
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South BrisbaneAustraliaUnknown status
Royal North Shore Hospital
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St LeonardsAustraliaUnknown status
Toowoomba Cancer Research Centre
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ToowoombaAustraliaUnknown status
Townsville Hospital
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TownsvilleAustraliaUnknown status
Premion
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TugunAustraliaUnknown status
Riverina Cancer Care Centre
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Wagga WaggaAustraliaUnknown status
Sydney Adventist Hospital
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WahroongaAustraliaUnknown status
Westmead Hospital
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WestmeadAustraliaUnknown status
Princess Alexandra Hospital
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WoolloongabbaAustraliaUnknown status
Auckland Hospital
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AucklandNew ZealandUnknown status
Christchurch Hospital
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ChristchurchNew ZealandUnknown status
Dunedin Hospital
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DunedinNew ZealandUnknown status
Auckland Radiation Oncology
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EpsomNew ZealandUnknown status
Wellington Hospital
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NewtownNew ZealandUnknown status
Palmerston North Hospital
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Palmerston NorthNew ZealandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.