Status:
ACTIVE_NOT_RECRUITING
Radiotherapy - Adjuvant Versus Early Salvage
Lead Sponsor:
Trans Tasman Radiation Oncology Group
Collaborating Sponsors:
Urological Society of Australia and New Zealand (USANZ)
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
This is a prospective, multi-centre, international, randomised controlled trial with a 1:1 allocation ratio. Patients with positive margins and/or pT3 disease will be randomised to adjuvant RT (Standa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 3 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
333 Patients enrolled
Trial Details
Trial ID
NCT00860652
Start Date
March 3 2009
End Date
December 1 2026
Last Update
November 18 2022
Active Locations (36)
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1
Campbelltown Hopsital
Campbelltown, New South Wales, Australia, 2170
2
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
3
Coffs Harbour Health Campus, NCCI
Coffs Harbour, New South Wales, Australia, 2450
4
Radiation Oncology Associates
Darlinghurst, New South Wales, Australia, 2010