Prostate Cancer Clinical Trial
— RAVESOfficial 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.
Verified date | November 2022 |
Source | Trans Tasman Radiation Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Active, not recruiting |
Enrollment | 333 |
Est. completion date | December 2026 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Australia | 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 | Peter MacCallum Cancer Centre | East Melbourne | Victoria |
Australia | Radiation Oncology Gold Coast | Gold Coast | Queensland |
Australia | Austin Hospital | Heidelberg West | Victoria |
Australia | Royal Brisbane and Women's Hospital | Herston | Queensland |
Australia | Nepean Hospital | Kingswood | New South Wales |
Australia | St George Hospital | Kogarah | New South Wales |
Australia | Liverpool Hospital | Liverpool | New South Wales |
Australia | The Alfred/WBRC | Melbourne | Victoria |
Australia | Fiona Stanley Hospital | Murdoch | Western Australia |
Australia | Oceania Oncology | Nambour | Queensland |
Australia | Sir Charles Gairdner Hospital | Nedlands | Western Australia |
Australia | Calvary Mater Newcastle | Newcastle | New South Wales |
Australia | Central West Cancer Services (Orange Health) | Orange | New South Wales |
Australia | Perth Radiation Oncology | Perth | Western Australia |
Australia | Royal Perth Hospital | Perth | Western Australia |
Australia | Port Macquarie Base Hospital, NCCI | Port Macquarie | New South Wales |
Australia | Radiation Oncology - Mater Centre | South Brisbane | Queensland |
Australia | Royal North Shore Hospital | St Leonards | New South Wales |
Australia | Toowoomba Cancer Research Centre | Toowoomba | Queensland |
Australia | Townsville Hospital | Townsville | Queensland |
Australia | Premion | Tugun | Queensland |
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 | Princess Alexandra Hospital | Woolloongabba | Queensland |
New Zealand | Auckland Hospital | Auckland | |
New Zealand | Christchurch Hospital | Christchurch | |
New Zealand | Dunedin Hospital | Dunedin | |
New Zealand | Auckland Radiation Oncology | Epsom | Auckland |
New Zealand | Wellington Hospital | Newtown | Wellington |
New Zealand | Palmerston North Hospital | Palmerston North |
Lead Sponsor | Collaborator |
---|---|
Trans Tasman Radiation Oncology Group | Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Urological Society of Australia and New Zealand (USANZ) |
Australia, New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Quality of Life | Final Analysis will be after 160 events, estimated to be five years after the end of accrual | ||
Secondary | Toxicity | Final analysis will be after 160 events, estimated to be 5 years after end of accrual. | ||
Secondary | Anxiety/Depression | Final analysis will be after 160 events, estimated to be 5 years after end of accrual. | ||
Secondary | Biochemical failure-free survival | Final analysis will be after 160 events, estimated to be 5 years after end of accrual. | ||
Secondary | Overall survival | Final analysis will be after 160 events, estimated to be 5 years after end of accrual. | ||
Secondary | Disease-specific survival | Final analysis will be after 160 events, estimated to be 5 years after end of accrual. | ||
Secondary | Time to distant failure | Final analysis will be after 160 events, estimated to be 5 years after end of accrual. | ||
Secondary | Time to local failure | Final analysis will be after 160 events, estimated to be 5 years after end of accrual. | ||
Secondary | Time to the initiation of androgen ablation | Final analysis will be after 160 events, estimated to be 5 years after end of accrual. | ||
Secondary | Quality adjusted life years | Final analysis will be after 160 events, estimated to be 5 years after end of accrual. | ||
Secondary | Cost-utility | Final analysis will be after 160 events, estimated to be 5 years after end of accrual. |
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