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.
18 Years
N/A
Male
Prostate Cancer
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Biochemical failure: PSA ≥ 0.4 ng/ml and rising following RT
Outcome Time Frame:
After 160 events have been observed, expected to be 5 years after recruitment closes
Safety Issue:
No
Principal Investigator
Maria Pearse, MBChB
Investigator Role:
Study Chair
Investigator Affiliation:
Trans-Tasman Radiation Oncology Group (TROG)
Authority:
Australia: Human Research Ethics Committee
Study ID:
TROG 08.03
NCT ID:
NCT00860652
Start Date:
March 2009
Completion Date:
December 2020
Related Keywords:
- Prostate Cancer
- Oncology
- Prostate Cancer
- Radiotherapy
- Radical Prostatectomy
- Prior Radical Prostatectomy (RP)
- Histological Confirmation of adenocarcinoma of the prostate
- Positive margins and/or extraprostatic extension (EPE)
- Prostatic Neoplasms
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