Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments adjuvant radiotherapy, early salvage radiotherapy
Phase phase 3
Sponsor Trans-Tasman Radiation Oncology Group (TROG)
Collaborator Urological Society of Australia and New Zealand (USANZ)
Start date March 2009
End date December 2021
Trial size 333 participants
Trial identifier NCT00860652, TROG 08.03

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Adjuvant Radiotherapy (64Gy in 32 Fractions to the prostate bed)
adjuvant radiotherapy ART, Radiation
Adjuvant RT (ART) commenced within 4 months of Radical Prostatectomy. 64Gy in 32 fractions to the prostate bed.
(Experimental)
Active Surveillance with Early Salvage Radiotherapy
early salvage radiotherapy SRT, Surveillance, Radiation
Active surveillance with early Salvage RT (SRT). SRT - 64Gy in 32 fractions to the prostate bed. RT should commence no later than 4 months following the first PSA measurement ≥ 0.2ng/mL.

Primary Outcomes

Measure
Biochemical failure: PSA ≥ 0.4 ng/ml and rising following RT
time frame: After 160 events have been observed, expected to be 5 years after recruitment closes

Secondary Outcomes

Measure
Quality of Life
time frame: Final Analysis will be after 160 events, estimated to be five years after the end of accrual
Toxicity
time frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Anxiety/Depression
time frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Biochemical failure-free survival
time frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Overall survival
time frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Disease-specific survival
time frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Time to distant failure
time frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Time to local failure
time frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Time to the initiation of androgen ablation
time frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Quality adjusted life years
time frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual.
Cost-utility
time frame: Final analysis will be after 160 events, estimated to be 5 years after end of accrual.

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official 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.
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 (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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Trans-Tasman Radiation Oncology Group (TROG).