PEACE V-STORM NCT03569241
ForPelvic nodal oligorecurrence (≤5 PET+ nodes) after radical local prostate tx
4yr 76% vs 63%, HR 0.62
80% CI 0.44-0.86, p=0.063 (α 0.20)
TL;DR4yr MFS 76% vs 63% (HR 0.62, 80% CI 0.44-0.86) favoring whole-pelvis ENRT over MDT for pelvic nodal oligorecurrence, both with 6mo ADT.
The RT signal is regional: 4yr locoregional RFS 85% vs 62% (HR 0.45), consistent with MDT failing mostly in the pelvis. The benefit sat in PSMA-staged pts (HR 0.48) and PSA <1 (HR 0.27), so it moves the choice from nodal SBRT to whole-pelvis 45/25 with 65 Gy SIB. Prostate bed inclusion, not the pelvic field, drove added GI toxicity.
In a man with up to five PET-detected pelvic nodal recurrences below the aortic bifurcation after radical local treatment, this supports whole-pelvis ENRT with nodal SIB over nodal SBRT alone, both with 6 mo ADT; it does not extend to para-aortic, bone, or visceral disease.
The RT signal is regional: 4yr locoregional RFS 85% vs 62% (HR 0.45), consistent with MDT failing mostly in the pelvis. The benefit sat in PSMA-staged pts (HR 0.48) and PSA <1 (HR 0.27), so it moves the choice from nodal SBRT to whole-pelvis 45/25 with 65 Gy SIB. Prostate bed inclusion, not the pelvic field, drove added GI toxicity.
11 details 2 trials watching
Phase 2, open-label, randomised (1:1) trial at 21 hospitals in Australia, Belgium, Italy, Norway, Spain, Switzerland. Minimisation stratified by PET tracer (choline vs PSMA) and MDT type (sLND vs SBRT/SIB). Median follow-up 50 mo (IQR 42-58).
Biochemical relapse after RP, postoperative RT or definitive RT, with ≤5 PET-detected pelvic nodes up to the aortic bifurcation. Excluded: bone/visceral mets, nodes above the bifurcation, testosterone <50 ng/dL. Median PSA 1.00 vs 0.85 ng/mL; 81% and 83% PSMA-staged.
ENRT: 45 Gy/25 fx whole pelvis + 65 Gy SIB to PET+ nodes, IMRT/VMAT mandatory. MDT: SBRT 30 Gy/3 fx every other day, 3 mm PTV margin, or extended sLND. Prostate bed RT ≥66 Gy/33 fx suggested for high-risk RP features in both arms, with benchmark-case QA.
6 mo LHRH agonist or antagonist in both arms, started no later than the first fraction. ADT was not to be restarted without clinical progression.
Primary: MFS (any M1 on PET or death). Secondary: bRFS, locoregional RFS, ADT-free survival, late G2+ GU/GI toxicity. OS, PCSS and time to castration resistance had too few events to report.
4yr cumulative G2+ GU 28% vs 31% (p=0.73) and GI 7% vs 9% (p=0.93), MDT vs ENRT. One ENRT pt had a recto-urethral fistula needing surgery. No treatment-related deaths.
First randomised comparison of MDT vs ENRT for nodal oligorecurrence. The single-arm GETUG-P07-OLIGOPELVIS reported 3yr bRFS 45% with ENRT, in a higher-PSA, choline-staged cohort. POINTER-PC (phase 3) and GETUG-P12-OLIGOPELVIS 2 are the confirmatory tests.
Prostate bed RT was unevenly used (25% vs 41%) and linked to both local control and GI toxicity, which muddies attribution to the pelvic field. No central PET review, and the PSA and nodal-level subgroups are post hoc.
The MFS gain is mostly prevention of further nodal (M1a) spread, consistent with PSMA PET under-staging microscopic pelvic disease. It does not settle whether the benefit holds at higher PSA or with choline staging, or whether it reaches survival.
| Endpoint | ENRT | MDT | HR (80% CI), p |
|---|---|---|---|
| MFS (1°) | 76% (69-81) | 63% (56-69) | 0.62 (0.44-0.86), p=0.063 |
| bRFS | 57% (50-64) | 41% (34-47) | 0.62 (0.48-0.80), p=0.014 |
| Locoregional RFS | 85% (80-90) | 62% (55-69) | 0.45 (0.31-0.65), p=0.0047 |
| ADT-free survival | 77% (70-82) | 60% (53-67) | 0.60 (0.43-0.83), p=0.049 |
| Subgroup | HR (80% CI) | Interaction p |
|---|---|---|
| PSMA PET | 0.48 (0.32-0.72) | 0.12 |
| Choline PET | 1.21 (0.64-2.28) | 0.12 |
| PSA <1 | 0.27 (0.14-0.52) | 0.029 |
| PSA ≥1 | 1.00 (0.67-1.50) | 0.029 |
| No common iliac node | 0.49 (0.33-0.74) | 0.20 |
| Common iliac node | 1.04 (0.55-1.95) | 0.20 |
| Endpoint | MDT | ENRT | p |
|---|---|---|---|
| 4yr cumulative G2+ GU | 27/97 (28%) | 29/93 (31%) | 0.73 |
| 4yr cumulative G2+ GI | 7/97 (7%) | 8/93 (9%) | 0.93 |
| G3 urinary incontinence | 6 (6%) | 9 (10%) | n/a |
| G3 diarrhoea | 1 (1%) | 2 (2%) | n/a |
CONSORT flow
Randomised phase 2 hit its MFS primary at 50 mo median f/u, but was powered at α 0.20 with 80% CIs; authors call for phase 3 confirmation (POINTER-PC).
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The longer read
The trial targets a question practice had already drifted into answering without randomised evidence. Nodal SBRT for PET-detected pelvic recurrence spread because it is short, targeted and tolerable, while whole-pelvis RT came with the intuition that anything visible on PET is the tip of a regional burden. PEACE V-STORM supports that intuition: the separation is carried by regional control, and the authors trace the MFS difference to prevented M1a nodal spread rather than to fewer bone or visceral events. That mechanism matters for how to read the result. ENRT is not buying systemic control; it is sterilising the pelvic nodal basin that PSMA PET cannot fully resolve, and MDT pts paid for that with repeat salvage (28 received another course of MDT).
The statistical frame deserves weight before the headline does. This is a screening phase 2 with α 0.20 and 80% CIs, and the primary p of 0.063 would not pass a conventional threshold. The direction is consistent across bRFS, locoregional RFS and ADT-free survival, which argues against chance, but the magnitude should be expected to shrink in a confirmatory trial. The authors themselves describe ENRT as a potential standard awaiting phase 3, and POINTER-PC is the trial that will decide it.
The subgroups point where the benefit likely lives. The effect was concentrated in PSMA-staged pts and those with PSA below 1, and absent with choline staging, PSA of 1 or higher, or common iliac involvement. Read together, ENRT seems to help most when disease is truly low-volume and pelvis-confined; once the burden is higher or already near the upper field edge, more lies outside the pelvis and a larger field adds little. Only the tracer split was prespecified, so these are hypothesis-generating, but they are biologically coherent and they narrow the population a reader should extrapolate to.
The prostate bed is the complication in this design. It was left to physician discretion, used more often in the ENRT arm, and in post hoc analysis tracked with both fewer local recurrences and more G2+ GI toxicity. Part of what looks like ENRT tolerability or ENRT benefit may therefore belong to prostate bed decisions rather than the pelvic nodal field. The encouraging finding is that the large pelvic field itself did not raise GI toxicity against SBRT, which weakens the main argument for the smaller field.
Against the ADT-sparing literature the authors cite (RADIOSA, EXTEND, EMBARK), the useful point is that local RT plus a short ADT course in both arms kept most pts off ADT for years. What remains unsettled is survival, which had too few events to report given near-universal cancer-specific survival in this setting, and whether the result survives central PET review and PSMA-only staging.