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ASTRO Annual Meeting 2025

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Confirmatory

MARCAP Consortium

ForLocalized prostate cancer, NCCN intermediate to high risk, definitive RT

TL;DRIPD meta-analysis, 10,853 pts: ADT added to RT improved MFS HR 0.83 and OS HR 0.86; dose escalation improved bRFS only.

Reported via UroToday →

Why it mattersRadiation oncology

The dose-invariance result is the load-bearing one: ADT's benefit was identical at ≥74 Gy and <74 Gy (both HR 0.83), so escalating dose does not buy out the ADT decision. Adjuvant prolongation carries the benefit (MFS HR 0.84), neoadjuvant prolongation does not (HR 0.95), which moves sequencing, not just duration.

Monday clinic

In NCCN intermediate- and high-risk localized prostate cancer receiving definitive RT, this supports adding and prolonging ADT on the adjuvant side rather than substituting dose escalation; it does not address node-positive or post-prostatectomy salvage settings.

The longer read
9 details 5 trials watching

Individual patient data meta-analysis from the MARCAP Consortium, 12 eligible trials, 10,853 patients, median follow-up 11.4 years (IQR 9.0-15.0). Three intensification questions analyzed separately: ADT use, neoadjuvant ADT prolongation, adjuvant ADT prolongation.

Localized prostate cancer treated with definitive radiotherapy, stratified by NCCN prognostic risk group. The RT ± ADT comparison ran 2,557 control vs 2,579 experimental (NCCN high 32.6% vs 32.8%, intermediate 47.6% vs 48.7%); the adjuvant-prolongation comparison was high-risk enriched at 71.5% vs 71.1% NCCN high across 1,900 vs 1,874 pts.

Dose was analyzed as a binary ≥74 Gy vs <74 Gy split, with the companion HEAT analysis using 64 to <74 Gy vs ≥74 Gy and escalation up to 79.2 Gy. Brachytherapy boost is discussed as an escalation route alongside external-beam dose.

ADT addition improved MFS HR 0.83 (0.77-0.89) and OS HR 0.86 (0.80-0.92). Adjuvant prolongation improved MFS HR 0.84 (0.78-0.91) and OS HR 0.85 (0.78-0.94); neoadjuvant prolongation did neither (MFS HR 0.95, OS HR 0.95). 10-yr MFS 61% (59-63) with ADT vs 52% (50-54) without; 10-yr OS 65% (63-67) vs 57% (55-59).

InterventionIntermediate riskHigh risk
ADT addition18.08.4
Adjuvant ADT prolongation16.110.4

The 2022 HEAT network meta-analysis (13 trials, 11,862 pts) found dose escalation improved biochemical RFS but not MFS or OS, and named high-dose RT plus long-term ADT the best strategy. PROG 05/09 and GETUG-18 are invoked to explain the gap: a 21% 5-year biochemical benefit in low risk where metastasis is rare, versus 3% in high risk where it is not.

localized NCCN intermediate- and high-risk prostate cancer treated with definitive external-beam radiotherapy over a long follow-up era
Does not represent node-positive, metastatic, or post-prostatectomy salvage populations, all of which sit outside the pooled trials.

The pooled trials span 30+ years of practice, so the RT technique behind the <74 Gy stratum is not the technique a reader delivers today. The stated optimal durations (closer to 12 months high risk, 24+ months very high risk) come from DHARMA, accepted but unpublished, so that specific number is not yet auditable.

The framing claim is that dose escalation and ADT are not interchangeable levers: escalation buys biochemical control, ADT buys metastasis-free and overall survival, and the two do not substitute. The dogma that dose escalation obviates ADT is named as widely repeated and never demonstrated.

IPD meta-analysis of randomised trials, large N, long f/u. Reinforces ADT intensification over dose escalation; no new randomisation, and duration guidance rests on unpublished DHARMA.

📚 Sources · 📄 1 paper
📄 PAPER · UroToday
ASTRO 2025: Quantifying the Benefits of Adding Androgen Deprivation Therapy versus Dose-Escalation for Prostate Cancer
Abstract
Prostate Cancer, Adding Androgen Deprivation Therapy versus Dose-Escalation for Prostate Cancer, reatment intensification strategies with radiotherapy.
📝 https://www.urotoday.com/conference-highlights/astro-2025/astro-2025-prostate-cancer/163446-astro-2025-quantifying-the-benefits-of-adding-androgen-deprivation-therapy-versus-dose-escalation-for-prostate-cancer.html
Consensus

ESTRO OCSCC Post-op CTV Delineation Guidelines

ForResected oral cavity SCC proceeding to post-operative radiotherapy

TL;DRFirst ESTRO guideline for post-op CTV delineation in oral cavity SCC: GTV-P pre-op + 10 mm composited with surgical defect/flap + 5 mm.

Why it mattersRadiation oncology

The margin recipe is asymmetric and that is the operative detail: 10 mm around the re-created pre-op GTV-P but only 5 mm around the surgical defect or flap, composited rather than either alone. Fig 3.1/3.2 shows why, the re-created GTV-P extended superiorly beyond the defect into infratemporal fossa, a geographical miss if you contour the defect alone.

Monday clinic

In resected OCSCC going to PORT, this supports re-creating the pre-op GTV-P from diagnostic MRI alongside the defect or flap rather than contouring the operative bed alone; it does not extend to R2 resections or other head and neck subsites.

The longer read
11 details 5 trials watching

ESTRO-convened multi-disciplinary expert group developing delineation guidelines through discussion and review of current evidence and international practice. Drafts were reviewed by HNSCC experts from countries outside the authorship (Japan, Hong Kong, Australia, Brazil, Mexico, Canada, Denmark, France, Spain, Poland, Ireland, UK) and modified on their feedback. No efficacy endpoint, no patient cohort.

Patients with oral cavity squamous cell carcinoma requiring post-operative radiotherapy, regardless of margin status and other histological risk factors. R2 resection (macroscopic residual disease) is explicitly out of scope. Companion background manuscript from the same group covers indications for PORT.

Planning CT 2.0 mm slices (range 1-3 mm), skull base to below sterno-clavicular joint, IV contrast mandatory, rigid co-registration with pre-op contrast-enhanced CT and/or MRI matched to C1-C3 vertebral bodies or nearby bone, not to soft tissue. CTV-P is the composite of GTV-P pre-op + 10 mm and surgical defect/flap + 5 mm, edited for bone, fascia, air, teeth and any intra-oral prosthesis. Nodal margin is 5 mm on GTV-N pre-op without pENE, 10 mm with pENE.

None. The stated aim is consistency of delineation to enable multi-institutional audit, clinical trials and RTQA. Authors position prospective audits of practice and outcomes as the route to establishing these volumes as standard of care.

resected oral cavity SCC receiving post-operative radiotherapy, including flap and non-flap reconstruction
Does not represent R2 resections, definitive (non-surgical) treatment, or non-oral-cavity head and neck subsites, which the authors flag as future work.

Extends the 2018 international CTV-P consensus for definitive HNSCC RT, whose 5+5 mm geometric expansion supplies the 10 mm used here around GTV-P pre-op. Cites the DAHANCA finding that geometric expansion is more conformal than anatomical margins, a post-hoc De-ESCALaTE analysis correlating the anatomical-to-geometric protocol change with lower late dysphagia, and non-randomised Dutch series where reducing the high-risk margin 10 mm to 6 mm cut salivary and constrictor dose. GORTEC's 2020 flap delineation guidance is named as an adjunct.

The 5 mm and 10 mm margins are imported from definitive-setting geometry and one surgical pathology series (>95 % of microscopic infiltration within 5 mm of GTV-P edge), not from post-operative recurrence mapping. The dose to dissected but uninvolved levels rests on a 1993 MD Anderson observation never tested prospectively, and is left to clinician discretion (EQD2 50-60 Gy). The whole method assumes accurate pre-op to planning CT co-registration, and the fallback where it fails is to treat the entire involved level, a larger volume.

The novel move is refusing to pick between the two available surrogates for a resected tumour: re-created pre-op GTV and operative bed are contoured independently and unioned, because each fails in a different direction. Fig 3.1 shows a GTV-P pre-op extending superiorly past the defect toward the infratemporal fossa, and Fig 8.1 a pectoralis major pedicled flap whose composite volume extends outside the oral cavity and is trimmed back. What is left unsettled is dose de-escalation to central flap tissue, where the guideline offers a flap avoidance structure for standardisation while stating there is a lack of data and consequently a lack of consensus.

VolumeIndicationEQD2 dose
CTV-P post-opPTV associated with post-op primary CTV60 Gy
CTV-P high-riskPositive (<1 mm) margin, whole CTV-P or localised stripover 60 Gy, e.g. 64-66 Gy
CTV-N1Involved nodal levels60 Gy
CTV-N2Undissected at-risk levels50 Gy
CTV-N2, dissected at-risk levelsOptimal dose unknown50 Gy to 60 Gy, clinician discretion
CTV-N high-riskPathological extranodal extensionover 60 Gy, e.g. 64-66 Gy

ESTRO expert guideline, no efficacy endpoint. Fills a documented gap (no prior post-op HNSCC CTV consensus); authors themselves position prospective audit as the validation step.

📚 Sources · 📄 1 paper
📄 PAPER Evans, Mererid; Bonomo, Pierluigi; Chan, Po Chung et al. · Radiotherapy and Oncology (2025-11)
Delineation of the post-operative primary tumour and nodal clinical target volumes in oral cavity squamous cell carcinoma: European Society for Radiotherapy and Oncology (ESTRO) clinical guidelines
Confirmatory

NRG-GU005 (quality of life)

ForLocalized intermediate-risk prostate cancer, median age 68, no ADT specified

EPIC-26 MCID decline, bowel and urinary irritative/obstructive at 2 yr (PRO analysis) safety

Bowel 33% vs 46% at 1 yr

p=0.002; 2yr bowel/UIO primary PRO endpoint not reported in source

TL;DRFewer MCID declines with SBRT at 1yr bowel (33% vs 46%, p=0.002) and sexual (34% vs 44%, p=0.026).

Reported via UroToday →

Why it mattersRadiation oncology

The QoL separation is domain-specific, not global: bowel and sexual at 1yr, urinary incontinence at 2yr, with no longitudinal effect in sexual or hormonal. Rectal manipulation (SpaceOAR 55%) and the 38.78 Gy PTV max cap gate transfer, since the bowel and GU signals came from a spacer-heavy, urethra-constrained delivery.

Monday clinic

In localized intermediate-risk prostate cancer choosing between 5-fraction SBRT and moderate hypofractionation, this supports SBRT on patient-reported bowel, sexual, and continence grounds; it does not speak to high-risk disease, nodal coverage, or oncologic non-inferiority, which the trial's primary endpoint carries.

The longer read

Also covered Aug 14

11 details

Randomized, non-blinded phase III, 1:1, N=698 (MH-IMRT 345, SBRT 353), stratified by Gleason score, PSA, and rectal manipulation. The trial's oncologic primary endpoint sits elsewhere; this analysis reports the patient-reported secondary endpoints.

Localized intermediate-risk prostate cancer, median age 68 (IMRT) and 69 (SBRT). Two patients were ineligible (one high-risk, one PSA out of window). Baseline EPIC domains were balanced across arms, all p≥0.093.

SBRT 36.25 Gy in 5 fractions delivered 2-3 per week, PTV expansion 5mm except 3mm posteriorly and anteriorly, PTV max capped at 38.78 Gy unless the urethra was visualized and contoured (acceptable variation 43.5 Gy). MH-IMRT 70 Gy/28 fx or 60 Gy/20 fx, PTV expansion 8mm except 5mm posteriorly. CTV was prostate ± 1cm proximal seminal vesicles. Rectal manipulation was common: SpaceOAR in 55% overall.

EPIC-26 at baseline, 12 and 24 months. MCID thresholds: >5 points urinary irritative/obstructive, >6 urinary incontinence, >10 sexual, >4 bowel and hormonal. Individual MCID rather than group mean scores was the analytic unit, with an exploratory longitudinal linear model adjusted for baseline score, arm, stratification factors, T-stage, age, and race.

The arm-level MCID and toxicity comparisons are tabulated above. Longitudinal modeling of urinary incontinence gave a least square mean difference of 2.91 (95% CI 0.85-4.97, p=0.0058) favoring SBRT, while sexual and hormonal domains showed no significant treatment effect.

Domain / timepointSBRTMH-IMRTp
Bowel, 1 yr33%46%0.002
Sexual, 1 yr34%44%0.026
Urinary incontinence, 2 yr26%35%0.023
EventSBRTMH-IMRTp
Treatment-related G≥3 GU0.6%2.5%0.04
Rectal hemorrhage, any grade10.5%17.3%0.01
Fatigue, any grade39.2%50.8%0.0025

Investigator-reported toxicity favored SBRT across the board: grade ≥3 GU 0.6% vs 2.5% (p=0.04), any-grade rectal hemorrhage 10.5% vs 17.3% (p=0.01), any-grade fatigue 39.2% vs 50.8% (p=0.0025). The GU finding is the one that most often runs the other way in ultrahypofractionation series, so it is worth reading as the trial's own answer to the pre-trial toxicity concern.

PACE-B is the other large randomized SBRT vs moderate hypofractionation comparison, and both trials show lower urinary incontinence decline with SBRT despite differing MCID definitions. Prior patient-level meta-analysis had suggested less clinically meaningful bowel and urinary irritative/obstructive decline at two years with SBRT, and the 1-year bowel result here is directionally consistent.

localized intermediate-risk prostate cancer treated to the prostate and proximal seminal vesicles, largely with a rectal spacer
Does not represent high-risk or node-positive disease, whole-pelvis fields, or post-prostatectomy salvage.

Differential attrition ran against the IMRT arm: 22 IMRT patients (6.4%) died or withdrew before year 1 versus 4 SBRT patients (1.1%), and 22 IMRT patients never received the assigned RT after withdrawal versus 1 in the SBRT arm. Completion was 79.9% (IMRT) and 84.0% (SBRT) at year 1. The domain-by-timepoint pattern (bowel and sexual at 1yr, incontinence at 2yr) is the kind of scattered significance that multiplicity should temper.

The trial was designed when the open question was whether five fractions cost the patient something. The PRO answer is that it does not, and the investigator-reported toxicity answer is that it may cost less. What the QoL data cannot do is settle whether SBRT is oncologically non-inferior, which is the primary endpoint and is not reported in this source.

CONSORT flow
Randomized 698
MH-IMRT
allocated 345
analyzed 258
SBRT
allocated 353
analyzed 293

Prespecified PRO secondary analysis of a phase III trial, non-blinded with patient-reported endpoints; aligns with PACE-B rather than establishing a new position. Oncologic primary endpoint not reported here.

  • Oncologic non-inferiority of SBRT vs MH-IMRT in this trial
  • Whether bowel benefit holds without rectal spacer
  • Durability of QoL separation beyond 2 years
📚 Sources · 📄 1 paper
📄 PAPER · UroToday
ASTRO 2025: Quality of Life Results from NRG-GU005: A Phase III Trial of SBRT vs. Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer
Abstract
prostate cancer, Stereotactic Body Radiotherapy (SBRT), Hypofractionated Intensity-Modulated Radiation Therapy (IMRT), NRG-GU005, RTOG 0415 study.
📝 https://www.urotoday.com/conference-highlights/astro-2025/astro-2025-prostate-cancer/163502-astro-2025-quality-of-life-results-from-nrg-gu005-a-phase-iii-trial-of-sbrt-vs-hypofractionated-imrt-for-localized-intermediate-risk-prostate-cancer.html
Early signal

10-yr SBRT Survival/Toxicity (Meier et al.)

ForLocalised low- or intermediate-risk prostate, no ADT, prostate volume up to 100 cc

TL;DR10-yr RFS 90% overall (94% LR, 86% IR) with 40 Gy/5 fx; grade 3 late toxicity 1.4-1.5%, no grade 4-5.

Why it mattersRadiation oncology

Two-thirds of relapses fell between 5 and 10 yr, so the reassurance PACE-B gives at 5 yr is provisional. The unfavorable IR subgroup sits at 77% (60-93) vs 92% for favorable IR (p=0.002), which is where the ADT-with-SBRT question actually lives, not in the pooled 86% IR number.

Monday clinic

In unfavorable intermediate-risk prostate considered for 40 Gy/5 fx monotherapy, the 77% 10-yr RFS (vs 92% favorable IR) is the number that informs an ADT discussion; the favorable IR and low-risk data do not carry that concern.

The longer read
11 details 4 trials watching

Investigator-initiated phase 2 nonrandomized trial across 21 centers (community, regional, academic), enrolling Jan 2008 to Apr 2010. 310 evaluable pts, median age 68, median follow-up 9 yr. Kaplan-Meier estimation with log-rank comparison of LR vs IR.

172 low-risk (T1b-T2a, Gleason 6, PSA under 10) and 138 intermediate-risk (T1b-T2b, Gleason 7 or Gleason 6 with PSA 10-20), all confirmed by central pathologic review. IR pts subclassified favorable vs unfavorable by MSK criteria. Prostate volume up to 100 cc allowed; prior TURP and baseline AUA score were not exclusions.

40 Gy in 5 fractions (8 Gy x 5, equivalent to ~100 Gy at 2 Gy/fx assuming a/b = 2) on a noncoplanar robotic platform. Fiducial tracking with translational and rotational intrafractional motion correction was mandatory. Androgen suppression was not allowed, so the outcomes are RT-attributable.

Relapse defined as biochemical failure (nadir + 2), clinical failure, or administration of any salvage, antiandrogen, or systemic therapy. Late toxicity was physician-reported, CTCAE v3, events beyond 3 mo. Day 0 was the last day of treatment.

10-yr OS 84% (76-91). Freedom from local failure 96% (93-99) overall. The separation that matters is within IR: favorable 92% vs unfavorable 77%, p = 0.002, whereas LR vs IR overall was not significant (p = 0.19).

Group10-yr RFS (95% CI)p
Whole group92% (87-96)n/a
Low risk94% (89-99)0.19 (LR vs IR)
Intermediate risk86% (77-94)0.19 (LR vs IR)
MSK favorable IR92% (90-100)0.002 (fav vs unfav)
MSK unfavorable IR77% (60-93)0.002 (fav vs unfav)

Four pts had five grade 3 events, all GU, and no grade 4-5 events occurred. Cumulative 10-yr grade 3 rates were 1.4% LR and 1.5% IR, far below the 10% rate the trial deemed acceptable. Grade 2+ GU 14% exceeds grade 2+ GI 2.1% by roughly sevenfold; no new late grade 3+ events after year 5.

IR relapse-free survival (86%) sits above the 74-78% 10-yr RFS of dose-escalated EBRT in RTOG 0126, and the authors note an updated HYPO-RT-PC now shows superior 10-yr RFS in the 6.1 Gy x 7 arm. Toxicity matched Fuller's CyberKnife trial but was lower than the PACE-B SBRT arm and PATRIOT, both of which treated substantial fractions on a conventional linac.

low- and favorable intermediate-risk organ-confined prostate cancer treated with robotic SBRT and tracking, without ADT
Does not represent unfavorable IR pts seeking equivalence with favorable IR, high-risk disease, node-positive disease, or delivery without intrafractional tracking.

The toxicity advantage over PACE-B and PATRIOT is confounded by platform, and the sponsor makes that platform, so the comparison cannot separate tracking from delivery-era and case-mix differences. Toxicity is physician-reported CTCAE only, with no patient-reported instrument, which understates GU bother relative to the EPIC-based comparators. Comparator EBRT series (RTOG 0126) predate modern IGRT.

The durability question, not the toxicity question, is what 10 yr answers here: two-thirds of relapses occurred between 5 and 10 yr, in this trial and in Fuller's. That timing means a 5-yr non-inferiority readout is structurally optimistic for both arms, and it reframes what PACE-B's 5-yr result can and cannot settle.

Single-arm nonrandomized phase 2, no concurrent comparator; sponsor-funded with device-specific delivery. Extends existing 5-yr SBRT data rather than testing a new question.

📚 Sources · 📄 1 paper
📄 PAPER Meier, Robert M.; Aghdam, Nima; Beckman, Alan C. et al. · European Urology (2026-05)
10-yr Survival and Toxicity Outcomes of Stereotactic Body Radiotherapy for Prostate Cancer: A Nonrandomized Clinical Trial
Consensus

American Radium Society AUC: Local Intraprostatic Recurrence

ForIsolated intraprostatic recurrence after definitive prostate RT

TL;DRSevere GU toxicity 20% after salvage RP vs 5.6% SBRT, 9.6% HDR: panel prefers biopsy-confirmed reirradiation.

Why it mattersRadiation oncology

The modality recommendation is a toxicity argument, not an efficacy one: MASTER found adjusted 5-yr recurrence-free survival of 50% to 60% across modalities with no survival difference vs RP, so reirradiation wins on severe GU toxicity (5.6% SBRT, 9.6% HDR vs 20% RP). Target volume then follows concordance, focal when mpMRI and systematic biopsy agree, whole-gland when they do not.

Monday clinic

In a man with rising PSA after conventionally fractionated definitive prostate EBRT whose PSMA PET and mpMRI show isolated intraprostatic recurrence, this supports biopsy confirmation before reirradiation rather than ADT alone; it does not extend to recurrence after primary brachytherapy or to nodal or distant failure.

The longer read
9 details 4 trials watching

PRISMA systematic review of PubMed and Embase (searched 28 June 2022) across four topics, excluding conference abstracts, non-English publications and series of fewer than five patients. A 12-member multidisciplinary panel of radiation oncologists, urologists and medical oncologists voted in two rounds by modified Delphi, with RAND methodology defining disagreement.

Scope is tier A disease, local-only intraprostatic radiorecurrence after definitive RT, with BCR defined as PSA 2.0 ng/ml above nadir. Evidence was restricted to men whose primary treatment was conventionally fractionated EBRT, and prior brachytherapy patients were excluded from the synthesis. Every variant presumes the patient wants curative-intent local salvage.

All accepted salvage schemas fit in six or fewer fractions. For focal salvage, GETUG-AFU 31 defines GTV by mpMRI plus choline PET with a 5-7 mm margin bound by the prostatic capsule; whole-gland salvage SBRT has prospective support from the Fuller series. Dose constraints and IGRT method are out of scope.

Long hormone courses are recommended against across all salvage scenarios. A short 4-6 mo LHRH agonist carries moderate consensus as a radiosensitizer with salvage SBRT in patients without cardiac history, weaker consensus with cardiac comorbidity, and classic ADT is preferred over novel hormonal agents.

The toxicity read that drives the reirradiation preference comes from pooled retrospective data that could not evaluate sexual toxicity and included no PSMA PET selection. Approaches that combine biopsy and ablation in one procedure are discouraged, since histologic confirmation must precede salvage.

No prior consensus guideline addressed intraprostatic radiorecurrence exclusively. The hormone-only comparators being displaced (Crook intermittent vs continuous ADT, TOAD immediate vs delayed, EMBARK enzalutamide MFS benefit) all enrolled before PET-based selection and none isolated a biopsy-confirmed, local-only cohort. RTOG 0526 reported after MASTER closed, adding prospective LDR support.

men with biopsy-confirmable, PSMA PET and mpMRI-localised isolated intraprostatic recurrence after conventionally fractionated definitive EBRT
Does not represent recurrence after primary brachytherapy or after moderate or ultrahypofractionated RT, nor nodal or distant failure (tiers B and C).

The search closed 28 June 2022 with an acknowledged lag to publication. MASTER carries between-study heterogeneity and follow-up asymmetry favoring older modalities, so its flat efficacy comparison is not a randomised one. The hormone recommendation rests on no qualifying study and is extrapolated from de novo intermediate-risk data.

Settled: image, biopsy with both systematic and targeted cores, then prefer reirradiation over hormones alone. Not settled: the modality for a second salvage, for castrate-resistant local recurrence, for short PSA doubling time, or after prior grade 3 toxicity, all of which drew panel disagreement.

VariantPanel position
Variant 1: isolated intraprostatic recurrenceReirradiation usually appropriate; cryotherapy or HIFU may be appropriate; ADT alone not recommended
Variant 2: short PSA doubling time, short interval to failureHIFU may be appropriate, but disagreement across all interventions; ADT alone not recommended
Variant 3: castrate-resistant local recurrenceDisagreement on intervention; androgen suppression uniformly not recommended
Variant 4: second local salvageDisagreement on which modality to select
Variant 5: prior grade ≥3 toxicityDisagreement; active surveillance may be appropriate; ADT can be considered
ModalitySevere GUSevere GI
Salvage RP (reference)20%1.8%
SBRT5.6%not reported in source
HDR brachytherapy9.6%0.0%, p < 0.01 vs RP
LDR brachytherapy9.1%not reported in source
ScenarioTarget volume
mpMRI and systematic biopsy agree on lesion locationFocal favored
History of grade ≥3 toxicity from initial RT courseFocal favored
Lesion occult on mpMRI, localised by PET plus systematic biopsyFocal or whole-gland both appropriate
mpMRI and systematic biopsy disagree on lesion locationWhole-gland preferred
Recurrent lesion in a different location to the index lesionWhole-gland preferred, focal appropriate in selected cases

Appropriate use criteria from a 12-member Delphi panel; the output is a recommendation grid, not an efficacy result. No trial endpoint, so efficacy verdicts do not apply.

📚 Sources · 📄 1 paper
📄 PAPER Valle, Luca F.; Jiang, Tommy; Rosenbloom, Ashton et al. · European Urology Oncology (2025-06)
American Radium Society Appropriate Use Criteria for the Workup and Treatment of Local Intraprostatic Recurrence of Prostate Cancer Following Definitive Radiotherapy
Challenges SOC

BART

ForPost-cystectomy MIBC, pT3-4 / pN+ / R+, chemo-treated, no adjuvant IO

2-year locoregional failure-free survival local control

87.1% vs 76.0%

HR 0.43, 95% CI 0.20-0.96, p=0.04

TL;DR2yr LRFFS 87.1% vs 76.0% with adjuvant pelvic RT after cystectomy, HR 0.43 (0.20-0.96), p=0.04; OS unchanged.

Reported via UroToday →

Why it mattersRadiation oncology

The RT read is the per-protocol and subgroup magnitude: LRFFS HR 0.27 (0.10-0.71) among those actually irradiated, and HR 0.22 (0.06-0.75) in pN+. Target was cystectomy bed plus full pelvic nodes to 50.4Gy/28fx with stoma-sparing IMRT, a plan deliverable in standard practice, and late G3+ toxicity was 8.4% vs 10.5%. That moves the offer-RT decision for pN+ disease.

Monday clinic

In pN+ or pT3-4 urothelial MIBC after cystectomy and cisplatin-based chemotherapy, this supports discussing adjuvant pelvic RT for locoregional control; it does not inform pts receiving adjuvant nivolumab, who were unrepresented here.

The longer read
12 details 2 trials watching

Phase III multicenter RCT, 1:1 adjuvant radiotherapy versus observation, N=153 accrued 2016-2024 (RT 77, observation 76). Stratified by nodal stage (N0 vs N+) and chemotherapy timing. Median follow-up 47 months; per-protocol comparison by log rank, with Fine-Gray competing-risk subdistribution HRs for LRFFS (competing risks distant metastases, non-cancer death) and DFS.

High-risk non-metastatic urothelial MIBC post radical cystectomy: T3-4, N1-3, or R+. 62% pT3-T4, 41% pN+, variant histology component in 28%. Median age 57, median nodes dissected 20, positive margin rate 4.6%, neobladder in 2.6%.

Chemotherapy was neoadjuvant in 71% and adjuvant in 20%; 9.2% received none. No patient received immunotherapy in either arm.

50.4Gy in 28 fractions to the cystectomy bed and pelvic nodes. CTV covered common iliac, internal and external iliac, presacral and obturator nodes plus the cystectomy bed. Stoma and bowel sparing IMRT with daily onboard image guidance. 63 of 77 allocated received planned RT.

Primary: 2-year locoregional failure-free survival. Secondary: bladder cancer-specific survival, disease-free survival, overall survival.

Primary endpoint met. Overall 37% recurred, 18% locoregionally (8% RT vs 26% observation, p=0.006), and there were no isolated locoregional recurrences in the RT arm. Survival endpoints all favored RT numerically without reaching significance.

EndpointAdjuvant RTObservationEffect size
LRFFS (primary)87.1%76.0%HR 0.43 (0.20-0.96), p=0.04
LRFFS per protocol93.2%75.0%HR 0.27 (0.10-0.71), p=0.008
DFS71.6%58.7%HR 0.62 (0.36-1.05), p=0.07
Bladder cancer-specific survival79.6%65.0%HR 0.59 (0.33-1.10), p=0.09
Overall survival70.4%57.4%HR 0.78 (0.49-1.26), p=0.31

Grade 3 GI events were low and no higher with RT (1.6% vs 4.1%); the cost was grade 2 GI (17.5% vs 1.4%) with no toxicity-related discontinuation. Late grade 3+ toxicity was similar (8.4% vs 10.5%, p=0.60).

The comparator that defines current adjuvant practice is CheckMate 274 (adjuvant nivolumab), which no BART patient received, so this addresses a locoregional failure mode nivolumab was never shown to control. Prior adjuvant RT evidence in this space is the smaller Egyptian NCI randomised experience; BART is described as the largest RCT here.

pT3-4 / pN+ / margin-positive urothelial MIBC after cystectomy and cisplatin-based chemotherapy, in a fit, young (median 57) population with thorough node dissection (median 20)
Does not represent pts on adjuvant immunotherapy, node-negative organ-confined disease, or those with inadequate lymphadenectomy.

Accrual over eight years fell short of target, so the survival endpoints are underpowered rather than negative: the OS CI (0.49-1.26) is compatible with both a substantial benefit and modest harm. 14 of 77 allocated to RT never received it and were analyzed with observation (n=90), which is the per-protocol comparison the headline HR 0.27 comes from.

This establishes that pelvic RT after cystectomy does what RT does elsewhere: it controls the field it treats, at an acceptable late-toxicity cost. What it does not establish is whether preventing a locoregional recurrence in a disease this systemically aggressive translates into survival, which the planned MERCY IPD meta-analysis is meant to answer.

CONSORT flow
Randomized 153
Adjuvant radiotherapy
allocated 77
2yr LRFFS 87.1%
Observation
allocated 76
2yr LRFFS 76.0%

Randomised, primary endpoint met, prespecified stratification. Adjuvant RT is not standard post-cystectomy; this is the first positive phase III. Underpowered for OS, no IO backbone.

📚 Sources · 📄 1 paper
📄 PAPER · UroToday
ASTRO 2025: Bladder Adjuvant Radiotherapy (BART): Clinical Outcomes from a Phase III Multicenter Randomized Controlled Trial
Abstract
ASTRO 2025 phase III Bladder Adjuvant Radiotherapy (BART), Advanced bladder cancer, cystectomy, advanced muscle invasive bladder cancer.
📝 https://www.urotoday.com/conference-highlights/astro-2025/astro-2025-bladder-cancer/163510-astro-2025-bladder-adjuvant-radiotherapy-bart-clinical-outcomes-from-a-phase-iii-multicenter-randomized-controlled-trial.html