Clinical trial · Interventional
Radiotherapy - Adjuvant Versus Early Salvage
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant Radiotherapy | Radiation | — | UNRESOLVED |
| Early Salvage Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adjuvant Radiotherapy (RT)
- description
- Adjuvant Radiotherapy (64Gy in 32 Fractions to the prostate bed)
- interventionNames
- Radiation: Adjuvant Radiotherapy
- type
- EXPERIMENTAL
- label
- Active Surveillance with Early SalvageRT
- description
- Active Surveillance with Early Salvage Radiotherapy
- interventionNames
- Radiation: Early Salvage Radiotherapy
Primary outcomes (1)
- measure
- Biochemical failure: PSA ≥ 0.4 ng/ml and rising following RT
- timeFrame
- After 160 events have been observed, expected to be 5 years after recruitment closes
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKneebone A, Fraser-Browne C, Duchesne GM, Fisher R, Frydenberg M, Herschtal A, Williams SG, Brown C, Delprado W, Haworth A, Joseph DJ, Martin JM, Matthews JHL, Millar JL, Sidhom M, Spry N, Tang CI, Turner S, Wiltshire KL, Woo HH, Davis ID, Lim TS, Pearse M. Adjuvant radiotherapy versus early salvage radiotherapy following radical prostatectomy (TROG 08.03/ANZUP RAVES): a randomised, controlled, phase 3, non-inferiority trial. Lancet Oncol. 2020 Oct;21(10):1331-1340. doi: 10.1016/S1470-2045(20)30456-3. PMID 33002437