An interventional study of Adjuvant Radiotherapy and Early Salvage Radiotherapy in Prostate Cancer, sponsored by Trans Tasman Radiation Oncology Group. Active, not recruiting at 36 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-18.
Sponsored by Trans Tasman Radiation Oncology Group · Not applicable, Interventional, and Treatment
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.
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.
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 333 is above the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Trans Tasman Radiation Oncology Group is the lead sponsor of 34 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Adjuvant Radiotherapy (64Gy in 32 Fractions to the prostate bed)
Radiation: Adjuvant Radiotherapy
Active Surveillance with Early Salvage Radiotherapy
Radiation: Early Salvage Radiotherapy
Adjuvant RT (ART) commenced within 4 months of Radical Prostatectomy. 64Gy in 32 fractions to the prostate bed.
Also known as: ART, 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.
Also known as: SRT, Surveillance, Radiation
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
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.
This study is active, not recruiting, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Trans Tasman Radiation Oncology Group