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
- Diseases
- Prostate cancer
- 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
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Campbelltown Hopsital Coordinator of this site? Confirm its status | Campbelltown | Australia | Unknown status |
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Coffs Harbour Health Campus, NCCI Coordinator of this site? Confirm its status | Coffs Harbour | Australia | Unknown status |
| Radiation Oncology Associates Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| St Vincent's Clinic Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | East Melbourne | Australia | Unknown status |
| Radiation Oncology Gold Coast Coordinator of this site? Confirm its status | Gold Coast | Australia | Unknown status |
| Austin Hospital Coordinator of this site? Confirm its status | Heidelberg West | Australia | Unknown status |
| Royal Brisbane and Women's Hospital Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| Nepean Hospital Coordinator of this site? Confirm its status | Kingswood | Australia | Unknown status |
| St George Hospital Coordinator of this site? Confirm its status | Kogarah | Australia | Unknown status |
| Liverpool Hospital Coordinator of this site? Confirm its status | Liverpool | Australia | Unknown status |
| The Alfred/WBRC Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Fiona Stanley Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| Oceania Oncology Coordinator of this site? Confirm its status | Nambour | Australia | Unknown status |
| Sir Charles Gairdner Hospital Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Calvary Mater Newcastle Coordinator of this site? Confirm its status | Newcastle | Australia | Unknown status |
| Central West Cancer Services (Orange Health) Coordinator of this site? Confirm its status | Orange | Australia | Unknown status |
| Royal Perth Hospital Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| Perth Radiation Oncology Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| Port Macquarie Base Hospital, NCCI Coordinator of this site? Confirm its status | Port Macquarie | Australia | Unknown status |
| Radiation Oncology - Mater Centre Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| Royal North Shore Hospital Coordinator of this site? Confirm its status | St Leonards | Australia | Unknown status |
| Toowoomba Cancer Research Centre Coordinator of this site? Confirm its status | Toowoomba | Australia | Unknown status |
| Townsville Hospital Coordinator of this site? Confirm its status | Townsville | Australia | Unknown status |
| Premion Coordinator of this site? Confirm its status | Tugun | Australia | Unknown status |
| Riverina Cancer Care Centre Coordinator of this site? Confirm its status | Wagga Wagga | Australia | Unknown status |
| Sydney Adventist Hospital Coordinator of this site? Confirm its status | Wahroonga | Australia | Unknown status |
| Westmead Hospital Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Woolloongabba | Australia | Unknown status |
| Auckland Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Christchurch Hospital Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
| Dunedin Hospital Coordinator of this site? Confirm its status | Dunedin | New Zealand | Unknown status |
| Auckland Radiation Oncology Coordinator of this site? Confirm its status | Epsom | New Zealand | Unknown status |
| Wellington Hospital Coordinator of this site? Confirm its status | Newtown | New Zealand | Unknown status |
| Palmerston North Hospital Coordinator of this site? Confirm its status | Palmerston North | New Zealand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.