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.
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 (Standard Arm) or active surveillance with salvage RT delivered at early relapse
(Experimental Arm). 64 Gy in 32 fractions will be delivered to the prostate bed. QoL
self-assessment questionnaires, Hospital Anxiety and Depression Score and toxicity will be
assessed at baseline, the end of RT and annually for 5 years. Patients will be seen by
their doctor 6 monthly for the first 5 years, then annually for the next 5 years. A blood
test measuring prostate specific antigen (PSA) is done 3 monthly for the first 5 years for
patients randomised to early salvage RT, then 6 monthly from years 5 to 10.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Maria Pearse, MBChB
Trans-Tasman Radiation Oncology Group (TROG)
Australia: Human Research Ethics Committee