Physician reactions to DASL-HiCaP
Posts by physicians about DASL-HiCaP during ESMO 2026 week (October 24–25, 2026), after the LBA4 abstract was released and Tamim Niazi presented the interim analysis in Presidential Symposium I. Each post is shown in full and verbatim, newest first, and linked to the original on X.
𝕏Congratulations to the DASL-HiCaP research team on these very promising initial results. However, I must be emphasized that this is a planned interim analysis, triggered when the primary endpoint MFS-CI crossed the pre-specified statistical boundary (HR 0.42; p = 0.0001), rather than the final analysis. Crucial secondary endpoints, such as OS and PCSS, remain immature in terms of data; therefore, the trial requires further follow-up. Furthermore, the current median follow-up is only about 4 years, whereas the regimen only administers ADT and Darolutamide for 2 years (96 ws). So, the post-treatment period is not yet long enough to determine whether the treatment efficacy is truly durable and maintained long-term, or if it is merely a temporary suppressive effect. @TonyFelefly @TylerSbrt @jryckman3
𝕏Good to have an alternative to adjuvant abiraterone for very high-risk localized prostate cancer. DASL also included early salvage RT after prostatectomy, which matters. OS is still immature, but the early MFS data look impressive. Comorbidities and drug interactions will still drive the choice. #ESMO2026 #prostatecancer
𝕏Presidential symposium 1️⃣!! DASL-HCaP: Darolutamide significantly improved MFS-CI when added to ADT and loco-regional RT for very high-risk localised, or biochemically persistent/recurrent prostate cancer. #ESMO26 @myESMO https://t.co/OTtR4z7yv1
𝕏#ESMO2026 前立腺癌DASL-HiCaPがPositive 放射線治療へのダロルタミド上乗せを支持する重要な結果 超高リスク限局性・術後早期再発前立腺癌1,106例 ADT＋放射線治療へのDar追加を検証 4年MFSは95% vs 88% HR 0.42、P=0.0001 PSA-PFSも改善 Grade ≥3 AEは43% vs 36% 利害のバランスが今後の課題 https://t.co/yY7K5FppG0
𝕏DASL-HiCaP — What's in a name? 🧠 DASL → Add DARO to ADT + RT HiCaP → High-risk prostate cancer 🎯 MFS HR 0.42 — 58% relative reduction in risk of metastasis or death. Three treatments. One stronger strategy. #ESMO26 #DASLHiCaP #ProstateCancer #Darolutamide #MVOnco @myESMO @OncoAlert
𝕏DASL-HiCaP | ESMO 2026 — LBA4 Can darolutamide challenge abiraterone in very high-risk localised prostate cancer? Four-part series: ① Why DASL-HiCaP? — Design & population ② Efficacy — MFS HR 0.42; 4-year MFS 95% vs 88% ③ Safety — Grade ≥3 AEs 43% vs 36% ④ STAMPEDE vs ENZARAD vs DASL-HiCaP — Clinical positioning Bottom line: Impressive MFS benefit (+7%; NNT ≈14), but OS remains immature. Abiraterone retains mature OS evidence from STAMPEDE. Ref: Niazi et al. DASL-HiCaP (ANZUP1801). ESMO 2026; LBA4. @myESMO @OncoAlert @larvol #ESMO26 #DASLHiCaP #ProstateCancer #Darolutamide #MVOnco
𝕏Cross-trial caveats obviously apply (different populations, controls, follow-up), but the RT-based regimen shows a striking benefit. Radiation oncology keeps raising the bar 📈 👏 @jryckman3 @TonyFelefly @seanmmcbride @cpeedell
𝕏🔹 DASL-HiCaP (RT + ADT + darolutamide): MFS HR 0.42, 4-yr MFS 95% vs 88% 🔹 PROTEUS (surgery + ADT + apalutamide): MFS HR 0.80, 5-yr MFS 78.2% vs 73.5%
Context: the PROTEUS figures in this post come from a separate trial (perioperative apalutamide with radical prostatectomy); see the KOL Pulse PROTEUS page.
𝕏🚨 Two major ARPI trials in high-risk localized prostate cancer, each adding a drug to standard local therapy 🧵 #ProstateCancer #RadOnc #pcsm https://t.co/bgjcc8ckZL
𝕏#ESMO26 @niazi_Dr7 DASL-HiCaP (ANZUP1801) n=1,106 | mFU 3.8 yrs | 85% definitive RT darolutamide + ADT + RT v placebo + ADT + RT MFS-CI ➡️ HR 0.42 (0.27–0.66) 4-yr MFS 95% vs 88% https://t.co/oEPnTAMLZc
𝕏#ESMO26 #DASLHiCaP #ProstateCancer #pcsm Thread 👇 https://t.co/0VmaUkiykW
𝕏DASL-HiCaP: primary MFS endpoint met. In trial-defined very high-risk nonmetastatic prostate cancer, adding darolutamide to ADT + RT improved conventional-imaging MFS: 4-year MFS: 95% vs 88% HR 0.42; P=0.0001 OS not significant yet. #DASLHiCaP #ESMO2026 #ProstateCancer
𝕏#ESMO26 DASL-HiCaP Presidential Discussant -- @Silke_Gillessen Differences in BL risk and pt selection may explain variation in treatment effects for STAMPEDE M0, ENZARAD, DASL-HiCaP Among N1 pts only, ARPI MFS benefit: ◾️STAMPEDE M0: HR 0.49, 95%CI 0.38-0.64 ◾️ENZARAD: HR 0.43, 95%CI 0.20-0.92 ◾️DASL-HiCaP: HR 0.39, 95%CI 0.19-0.81
𝕏🚨 🎗️ ESMO26 | DASL-HiCaP: Darolutamida no câncer de próstata de muito alto risco Estudo fase III | 1.106 pacientes ✅ 58% de redução no risco de metástases ou morte (HR 0,42; p=0,0001) ✅ Sobrevida livre de metástases em 4 anos: 95% vs. 88% ✅ Sobrevida livre de progressão do PSA: 91% vs. 83% (HR 0,47) ✅ Redução de 78% no risco de resistência à castração (HR 0,22) ✅ Benefício consistente nos principais subgrupos. A adição de darolutamida à radioterapia + bloqueio hormonal demonstrou benefício significativo no controle da doença. ⚠️ Sobrevida global ainda imatura (HR 0,88). DASL-HiCaP: potencial novo padrão de tratamento para pacientes selecionados de muito alto risco. #ESMO26 #DASLHiCaP #Darolutamida #ProstateCancer #GUOncology
𝕏Results from the DASL-HiCaP study were presented on October 24, 2026. DASL-HiCaP (ANZUP1801) – ESMO 2026 Study objective: To evaluate the addition of darolutamide to standard androgen deprivation therapy (ADT) and radiotherapy in patients with very high-risk localized prostate cancer. Phase III: 1,106 patients; randomized, double-blind, placebo-controlled. Treatment: Darolutamide 600 mg twice daily for 96 weeks + ADT and radiotherapy. Control: Placebo + ADT and radiotherapy. Median follow-up: 3.8 years. Primary endpoint: Imaging-based metastasis-free survival (MFS-CI) was significantly improved: HR 0.42 (95% CI 0.27–0.66; p=0.0001). The risk of PSA progression or death was reduced by 53%: HR 0.47 (95% CI 0.33–0.67). Overall survival: The difference was not yet statistically significant: HR 0.88 (95% CI 0.49–1.59). Safety Grade ≥3 adverse events occurred in 43% of patients in the darolutamide group and 36% in the placebo group. Grade ≥2 fatigue/asthenia was reported in 14% and 10% of patients, respectively. Clinical Take-Home Message Darolutamide + ADT + radiotherapy increased 4-year metastasis-free survival from 88% to 95% in patients with very high-risk localized prostate cancer. This represents an absolute improvement of 7 percentage points and a 58% relative reduction in the hazard of metastasis or death. These findings support treatment intensification in this patient population. However, as overall survival data remain immature, an overall survival benefit should not yet be considered established. Link : https://t.co/YmlFyx06Au #DASLHiCaP #ESMO2026 #ProstateCancer #Darolutamide #UroOncology
𝕏#DASL- HiCap Great to see another practice changing study with significant participation from Ireland Collaborations for the win @cancertrials_ie 🇮🇪 🤝🇦🇺 @ANZUPtrials https://t.co/WVcTJ9mjvH
𝕏2/n All patients received comprehensive, contemporary prostate and nodal RT. There was some contention that in the STAMPEDE trial, had nodal RT (or higher dose prostate-directed RT) been mandated, it might have reduced the benefit of Abi. Here that argument is moot. Further, the MFS benefit in Darolutamide was present regardless of PSMA PET staging, regardless of nodal status.
𝕏3/n Finally, as to the choice of ARPIs, I would argue Daro is substantially better tolerated than Abiraterone. The side effect profile reported by the team today is consistent with that conclusion.
𝕏1/n Major congrats to our DASL team, especially to @ChrisSweens1 and @niazi_Dr7, and a big thanks to the patients. Working with @ANZUPtrials and @ThePCCTC on DASL as US lead has been a career highlight. I'd contend this establishes a new standard of care in DASL very-high risk PCa. The conventional-image defined MFS benefit with the addition of Darolutamide to RT+ADT was extraordinarily robust; the DSMC recommended reporting out at IA. #ESMO26, #radonc, #medtwitter. @MSKCancerCenter @MSK_RadOnc. #pcsm Brief 🧵
𝕏DASL-HiCaP: darolutamide on top of 96 weeks of ADT plus RT improved MFS in very high-risk localized prostate cancer, HR 0.42, 4-yr MFS 95% vs 88%. 📈 n=1,106, interim at 67% of events, 46 mo follow-up. OS immature 📝 Thanks to @Silke_Gillessen putting this into context STAMPEDE M0 (HR 0.53) and ENZARAD (HR 0.88): not contradictory, the ARPI benefit tracks metastatic risk 🎯 N1 is the clearest indication. N0 is less clear, and Gleason seems to matter Every patient got pelvic RT, so who needs it in N0 not yet answered. @Niazi_Dr7 #ProstateCancer #GUonc #ESMO26
𝕏#ESMO26 Presidential Session presentation for DASL-HiCAP (ANZUP1801) @niazi_Dr7 @urotoday ⚡️MFS-CI Primary Endpoint: HR 0.42, 95%CI 0.27-0.66 ⚡️All secondary endpoints favoring addition of Daro ⚡️Limited additional toxicity by adding Daro https://t.co/PV190vLJzA https://t.co/lzN7ZApzii
𝕏Nice conclusion slides by @Silke_Gillessen @myESMO #ESMO26 https://t.co/py1hKaviCj
𝕏More pictures from a wonderful discussion! Many questions remain... https://t.co/ely9LsFQmA
𝕏GU à l'honneur in the Presidential Symposium today! Adding daro to RT + 2 yrs of ADT significantly improved MFS in very high-risk prostate cancer! Do we have a new definition of "very high risk" prostate cancer? I cannot wait to be back to GU clinic on Tuesday! As usual Dr. @Silke_Gillessen expertly discusses the results (yes I took pictures of every slide)! #ESMO26 @OncoAlert
𝕏Rather a brilliant discussion at the presidential #ESMO26 for the DASL very high risk prostate cancer trial The future is patient selection. The clearest indication is in pateints with N1 disease supported by results from thr other trials @OncoAlert @ChrisSweens1 @Uromigos https://t.co/Sr5myx9C6j
𝕏DASL-HiCaP at #ESMO26, presented by @Niazi_Dr7: darolutamide + RT + 2 yrs ADT vs placebo in very high-risk prostate cancer (n=1,106) ▪️ MFS HR 0.42, 4-yr MFS 95% vs 88% ▪️ PSA-PFS HR 0.47 ▪️ Time to CRPC HR 0.22 ▪️ OS immature (HR 0.88) #ProstateCancer https://t.co/pfDHyuM2qW
𝕏3. DASL-HiCaP: PhIII, Darolutamide + ADT + RT in very high-risk PCa (n=1106, incl BCR post-RP) - 4y MFS-CI 95% vs 88% (HR 0.42) - OS immature - ARPIs will play a bigger role in early prostate cancer (DASL-HiCaP & PROTEUS) 4/5 https://t.co/wEFefXA02T https://t.co/0rLGbfIjH7
𝕏Darolutamide combined with radiotherapy significantly prolonged metastasis-free survival in patients with high-risk localized prostate cancer. ARPIs also appear to be effective in appropriately selected patients with localized high-risk disease. The question is: Is PSMA PET–defined metastasis-free survival truly a surrogate endpoint for overall survival? #ESMO26
Context: the DASL-HiCaP primary endpoint was metastasis-free survival by conventional imaging (CT and/or bone scan); baseline PSMA PET was optional and not used for eligibility (ESMO 2026 LBA4 abstract and subgroup slide).
𝕏@niazi_Dr7 with #DASL-HICAP trial ADT/XRT +/- darolutamide in high risk #prostatecancer. Darolutamide improves distant metastasis free survival. Similar AE profile. Highly powered trial. @ANZUPtrials @oncoalert @myESMO #ESMO26 https://t.co/5XfILDi89w
𝕏Phase III #DASLHiCaP (N=1,106): #darolutamide + ADT + RT in very high-risk localized or early post-prostatectomy prostate cancer: #impressive #MFS (4-year MFS: 95% vs 88%,HR 0.42; p=0.0001). OS data remain immature. Promising/potential new tx paradigm #ESMO26 @OncoAlert https://t.co/BB5cz56XMp
𝕏Darolutamide with ADT and locoregional radiation therapy (RT) in high-risk prostate cancer (DASL) showed Darolutamide reduced the risk of relapse and time to CRPC. Tolerably was good. #ESMO26 https://t.co/KBTpYUF4cl
𝕏Putting STAMPEDE, ENZARAD, PROTEUS & DASL into context with the latest #ESMO26 updates: STAMPEDE: Abiraterone-based intensification improved MFS AND OS, predominantly with RT. New #ESMO26 Decipher data suggests differential abi benefit in cN0 disease (interaction P=.01); using this to omit treatment still requires validation. ENZARAD: At 8 years, MFS was 74% vs 72% (HR 0.88; P=.34). No significant overall MFS benefit from enza + ADT/RT. The cN1/planned pelvic RT subgroup signals remain hypothesis-generating. DASL: new at #ESMO26: 1,106 patients; 96 weeks of daro v. placebo + ADT + prostate/bed AND pelvic RT. Four-year conventional-imaging MFS: 95% vs 88% (HR 0.42). Very-high-risk population, including selected postoperative patients. Interim analysis; OS immature. PROTEUS main trial: Perioperative apa + ADT improved 5-year PSMA-inclusive MFS versus ADT alone: 78.2% vs 73.5% (HR 0.80). Conventional-imaging MFS was not statistically significant. #ESMO26 post hoc PSA-response analysis adds prognostic information. PROTEUS randomized substudy: new at #ESMO26: Perioperative apa/ADT + RP/PLND (n=102) v. immediate RP/PLND (n=306). At 37.8 months’ follow-up: • 3-year EFS: 63.0% vs 41.4%; HR 0.38. • Secondary PSMA-inclusive MFS: HR 0.49; nominal P=.0193. • Subsequent postoperative RT: 20% vs 43%. The substudy strengthens a "perioperative strategy". But conventional-imaging entry followed by PSMA-inclusive endpoints matters. PSA-based EFS, conventional MFS and PSMA-inclusive MFS are different endpoints. These trials support specific intensification strategies; they cannot rank the drugs or establish RP-versus-RT superiority. The decision remains who benefits enough to justify the ENTIRE treatment burden.
𝕏🚨📣📣 #ESMO26 presidential: @niazi_Dr7 Adding darolutamide to ADT + RT dramatically ⬇️ risk of metastasis or death in high-risk localized prostate cancer. Phase 3 DASL-HiCaP = 58% ⬇️ in MFS (HR 0.42) + early OS signal (HR 0.88). #ProstateCancer #RadOnc #pcsm @ChrisSweens1 https://t.co/7JuxQ3qSr9
𝕏DASL-HiCaP: ADT + RT +/- Darolutamide in very high risk localized prostate cancer or biochemically persistent/recurrent disease. Improvement in MFS. New evidence that ARPIs have a role in localized disease. Patient selection will be key. #ESMO26 https://t.co/dWHDhRzlvT
𝕏Compelling presentation by Tamim Niazi! DASL-HiCaP: adding darolutamide to ADT + RT improved MFS in very high-risk nonmetastatic prostate cancer (HR 0.42; 4-year MFS 95% vs 88%). Important phase III evidence for intensification! #ESMO26 @oncoalert @myESMO https://t.co/ALgNRFY3ka
𝕏Circulating — confirm at PS I (Niazi). Solid across independent posts: 4-yr MFS 95% vs 88%, HR 0.42 (0.27–0.66). Absolute +7 pp · NNT ≈14 if rates hold. OS not clear at interim. The open question is unchanged from the pre-meeting frame: does a metastasis-free win at this magnitude justify 96 weeks of added AR blockade on top of ADT + RT?
𝕏Seven more men in a hundred stay metastasis-free at 4 years — if circulating DASL-HiCaP rates hold. Very high-risk localised prostate cancer: darolutamide + ADT + RT vs placebo + ADT + RT (n=1,106). 4-yr MFS 95% vs 88% (HR 0.42, 95% CI 0.27–0.66); OS not clear at interim. Absolute Δ +7 pp · NNT ≈14. Confirm at PS I (Niazi). #ESMO26 #LBA4 @zklaassen_md @jryckman3 @niazi_Dr7
𝕏⚡️LBA4⚡️ DASL-HiCaP (ANZUP1801) Ph 3 RCT #ESMO26 Daro + ADT and definitive/salvage locoregional RT for very HR PCa @urotoday 🚨n=1,106; mFU 3.8 yrs; 85% definitive RT 🚨Primary EP MFS by CI: ⏫ for Daro vs PBO - 4-year MFS-CI 95% vs 88% - HR 0.42 (95% CI 0.27 to 0.66)
𝕏Improved MFS w/ darolutamide in DASL-HiCaP! 📌 1,106 very high-risk prostate cancer pts, incl persistent/rising PSA after RP. Randomised to darolutamide vs placebo w/ ADT + RT. 📌 Median age 71; GS 9-10 73%; CT N+ 29%; prior RP 15%. 📌 4y MFS on conventional imaging: 95% vs 88%, HR 0.42 (95% CI 0.27-0.66). No clear OS benefit yet. 📌 All prescribed prostate/bed AND pelvic nodal RT, w/ 96 wk ADT. 📌 N+ = CT/MRI >10 mm short axis or path confirmation (PSMA PET alone insufficient if ≤10 mm). Side note: RT dose/fx and PSMA staging use aren't reported in the abstract. #radonc #ESMO26 #PCSM
DASL-HiCaP Key Takeaways
Metastasis-free survival by conventional imaging (primary endpoint, met)
Adding darolutamide to ADT and radiotherapy lengthened MFS-CI: 4-year MFS-CI 95% vs 88% with placebo, HR 0.42 (95% CI 0.27–0.66), 27 vs 63 events, p=0.0001. The observed p-value met the pre-specified interim rejection boundary of 0.012. Of the MFS-CI events, metastases accounted for 9 vs 46 and deaths without prior metastases for 18 vs 17. (ESMO 2026 LBA4, Niazi; pre-specified interim analysis after 87 MFS-CI events; median follow-up 3.8 years)
Darolutamide vs placebo (both + ADT + RT): 4-yr MFS-CI 95% vs 88% · HR 0.42Source: ESMO 2026 LBA4 abstract (Niazi et al.), Presidential Symposium I ↗
MFS-CI by arm (presented Kaplan-Meier slide)
| Measure | RT + ADT + darolutamide | RT + ADT + placebo |
|---|---|---|
| Patients randomised | 553 | 553 |
| MFS-CI events, n (%) | 27 (5%) | 63 (11%) |
| Metastases | 9 (33% of events) | 46 (73% of events) |
| Death without prior metastases | 18 (67% of events) | 17 (27% of events) |
| 4-year MFS-CI | 95% | 88% |
HR 0.42 (95% CI 0.27–0.66), p=0.0001. Number at risk (number censored) by month, as printed under the curve:
| Month | Darolutamide | Placebo |
|---|---|---|
| 0 | 553 (0) | 553 (0) |
| 12 | 535 (15) | 536 (11) |
| 24 | 526 (18) | 516 (14) |
| 36 | 460 (78) | 448 (69) |
| 48 | 219 (313) | 213 (288) |
| 60 | 58 (468) | 63 (429) |
Source: primary-endpoint slide, ESMO 2026 LBA4 (Niazi), interim analysis. No data cut-off date was printed on the slide.
Secondary endpoints (interim; events, % event-free at 4 years)
| Endpoint | Darolutamide (n=553) | Placebo (n=553) | HR (95% CI) |
|---|---|---|---|
| PSA-PFS | 46 (91%) | 95 (83%) | 0.47 (0.33–0.67) |
| Castration-resistant prostate cancer (CRPC) | 6 (99%) | 28 (95%) | 0.22 (0.09–0.52) |
| Subsequent hormonal therapy | 19 (96%) | 52 (90%) | 0.36 (0.21–0.60) |
| Prostate cancer-specific survival | 4 (99%) | 7 (99%) | 0.58 (0.17–1.97) |
| Overall survival | 21 (97%) | 24 (95%) | 0.88 (0.49–1.59) |
PSA-PFS, time to CRPC and time to subsequent hormonal therapy favoured darolutamide. Overall survival and prostate cancer-specific survival are immature: deaths 21 vs 24 (OS HR 0.88, 95% CI 0.49–1.59), of which 4 vs 7 were from prostate cancer. Follow-up continues to the final analysis at about 130 MFS-CI events. (ESMO 2026 LBA4, Niazi; pre-specified interim analysis after 87 MFS-CI events; median follow-up 3.8 years)
PSA-PFS HR 0.47 · CRPC HR 0.22 · OS immature (HR 0.88)Source: secondary-endpoints slide, LBA4 (posted by @zklaassen_md) and LBA4 abstract table ↗
Safety
Any grade ≥3 adverse event: 43% with darolutamide vs 36% with placebo. Grade ≥2 adverse events of special interest: fatigue/asthenia 14% vs 10%, hypertension 7% vs 9%, fractures 2% vs 3%, cardiac 3% vs 3% (ESMO 2026 LBA4 abstract). Adverse events of special interest of any grade, as shown on the presented slide:
| Event (any grade) | Darolutamide n (%) | Control n (%) |
|---|---|---|
| Vasodilatation and flushing | 364 (66%) | 351 (64%) |
| Fatigue/asthenic conditions | 350 (64%) | 313 (57%) |
| Hypertension | 42 (8%) | 56 (10%) |
| Diabetes mellitus and hyperglycaemia | 41 (7%) | 46 (8%) |
| Mental impairment disorders | 46 (8%) | 38 (7%) |
| Rash | 42 (8%) | 32 (6%) |
| Depressed mood disorders | 34 (6%) | 34 (6%) |
| Fall | 26 (5%) | 31 (6%) |
| Breast disorders/gynaecomastia | 33 (6%) | 24 (4%) |
| Cardiac disorders | 21 (4%) | 19 (3%) |
| Weight decreased | 23 (4%) | 12 (2%) |
| Bone fractures | 15 (3%) | 17 (3%) |
| Cerebral ischaemia | 4 (1%) | 6 (1%) |
| Interstitial lung disease | 0 | 4 (1%) |
| Cerebral and intracranial haemorrhage | 3 (1%) | 1 (0%) |
| Seizure | 0 | 2 (0%) |
The abstract figures are grade ≥2; the slide figures are any grade. They are different cuts of the same safety data and are not interchangeable. Cardiac disorders and cerebral/intracranial haemorrhage counts carry an asterisk on the slide whose footnote is not legible in the photographs.
Grade ≥3 AEs 43% vs 36%Source: ESMO 2026 LBA4 abstract (Niazi et al.), Presidential Symposium I ↗ · AESI slide (posted by @zklaassen_md) ↗
Subgroups (MFS-CI, pre-specified)
HR by subgroup (darolutamide vs placebo): pelvic nodal involvement 0.39 (0.19–0.81) vs none 0.44 (0.25–0.78); previous radical prostatectomy 0.1 (0.01–0.79) vs none 0.48 (0.3–0.77); Gleason 9–10 0.35 (0.2–0.6) vs others 0.71 (0.3–1.66); PSMA PET at baseline 0.45 (0.24–0.85) vs none 0.39 (0.21–0.75). No interaction p-value was below 0.05 (unadjusted 0.08–0.80; adjusted 0.50–0.80). Baseline PSMA PET was at the treating physician’s discretion and did not count toward eligibility. (ESMO 2026 LBA4, Niazi; pre-specified interim analysis after 87 MFS-CI events; median follow-up 3.8 years)
Source: subgroup forest-plot slide, LBA4 (posted by @QianJanieQin) ↗Regulatory status
⚠️ Investigational: darolutamide is not approved for very high-risk localised or post-prostatectomy prostate cancer treated with radiotherapy (Orion press release, October 24, 2026). ✅ Darolutamide (NUBEQA®, Bayer) is FDA-approved for non-metastatic castration-resistant prostate cancer and for metastatic castration-sensitive prostate cancer, with or without docetaxel (Bayer press release, October 24, 2026). Bayer press release ↗
KOL pulse
Physicians posting from the Presidential Symposium mostly called the MFS result positive. Sean McBride, the US lead, wrote that it establishes a new standard of care. Others, including invited discussant Silke Gillessen in her slides, noted that overall survival is immature, that the clearest case is node-positive (N1) disease, and that every patient received pelvic radiotherapy.
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Top KOLs Discussing DASL-HiCaP
DASL-HiCaP Key Slides & Visuals
ESMO 2026 slides
DASL-HiCaP Trial Design
DASL-HiCaP (Darolutamide Augments Standard therapy for Localised very High-risk Cancer of the Prostate; ANZUP1801; NCT04136353) is an investigator-initiated, international, randomised, double-blind, placebo-controlled phase 3 trial. It asked whether adding darolutamide to the standard of 96 weeks of ADT plus radiotherapy to the prostate or prostate bed and pelvic nodes improves outcomes in very high-risk localised prostate cancer, or in persistent/rising PSA within 1 year after radical prostatectomy.
Tamim Niazi (McGill University / Jewish General Hospital, Montreal) presented the pre-specified interim analysis as LBA4 in Presidential Symposium I at ESMO 2026 on October 24, 2026; Silke Gillessen was the invited discussant. The independent data and safety monitoring committee reviewed the interim result for external disclosure under the protocol’s p<0.012 rule.
Study Design
Phase 3, randomised 1:1, double-blind, placebo-controlled; 1,106 patients randomised April 30, 2020 to August 9, 2023 in Australia, New Zealand, Canada, the United States, Ireland and the United Kingdom. Stratified by previous radical prostatectomy, planned docetaxel use and clinical or pathological pelvic N1. (LBA4 abstract; study design slide; Bayer press release)
Population
Primary radiotherapy (85%, n=935): ISUP grade group 5; grade group 4 with cT2b–T4, rT3a+ or PSA >20 ng/mL; or cN1. Salvage radiotherapy (15%, n=171): PSA persistence or rise ≥0.1 ng/mL within 12 months of prostatectomy plus pN1/cN1, grade group 5, or grade group 4 with pT3a+. Median age 71 (IQR 65–75); Gleason 9–10 in 73%; pelvic nodal involvement in 29%; prior prostatectomy in 15%. Nodal staging was by CT/MRI; PSMA PET (done in 613 patients, 55%) did not count toward eligibility. (LBA4 abstract; design and baseline slides; discussant slide)
Interventions
Darolutamide 600 mg or placebo twice daily for 96 weeks, plus an LHRH analogue for 96 weeks and radiotherapy to the prostate/prostate bed and pelvic lymph nodes. (LBA4 abstract)
Endpoints
Primary: metastasis-free survival by conventional imaging (CT and/or technetium bone scan; MFS-CI). Secondary: overall survival, prostate cancer-specific survival, PSA-PFS, time to subsequent hormonal therapy, time to castration resistance, adverse events, health-related quality of life. (LBA4 abstract; study design slide)
Statistics
One pre-specified interim analysis after 87 MFS-CI events (67% of the 130 needed for the final analysis), with disclosure if the 2-sided stratified log-rank p was <0.012. The interim was triggered after the 87th centrally corroborated event. (LBA4 abstract; primary-endpoint and study design slides)
Sponsor & groups
Lead sponsor University of Sydney (Sydney Clinical Trials Centre) with ANZUP; collaborators Canadian Cancer Trials Group, Cancer Trials Ireland, Memorial Sloan Kettering Cancer Center and the Prostate Cancer Clinical Trials Consortium; funded by Bayer, which supplied darolutamide. (ClinicalTrials.gov; ANZUP media release)
Design sources: ESMO 2026 LBA4 (Niazi), interim analysis; ClinicalTrials.gov NCT04136353 (status: active, not recruiting).
DASL-HiCaP in the News
DASL-HiCaP FAQ
What is the DASL-HiCaP trial?
DASL-HiCaP (ANZUP1801, NCT04136353) is an international, double-blind phase 3 trial that randomised 1,106 men with very high-risk localised prostate cancer, or persistent/rising PSA soon after prostatectomy, to darolutamide or placebo for 96 weeks on top of 96 weeks of ADT and prostate/pelvic radiotherapy. See Trial Design.
What did DASL-HiCaP show at ESMO 2026?
At the pre-specified interim analysis, darolutamide met the primary endpoint, metastasis-free survival by conventional imaging (4-year 95% vs 88%, HR 0.42, p=0.0001). Overall survival is immature. All figures with their source are in At a Glance.
Is darolutamide approved for very high-risk localised prostate cancer?
No. Use with ADT and radiotherapy in this setting is investigational. Darolutamide (NUBEQA) is FDA-approved for non-metastatic castration-resistant and metastatic castration-sensitive prostate cancer.
Did darolutamide improve overall survival?
Not yet shown. At the interim analysis there were 21 vs 24 deaths (OS HR 0.88, 95% CI 0.49–1.59) and follow-up is continuing; the investigators said follow-up will confirm the surrogacy of MFS-CI for overall survival.
Which patients benefited most?
The benefit was seen across pre-specified subgroups. The invited discussant, Silke Gillessen, said the clearest indication is node-positive (N1) disease and that for N0 disease the indication is less clear. Subgroup figures are in At a Glance.
What were the side effects?
Any grade ≥3 adverse events occurred in 43% with darolutamide vs 36% with placebo. Rates of adverse events of special interest are in At a Glance.
Key KOL Sentiments - DASL-HiCaP
Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Last updated October 25, 2026. Statistics carry their source and data-cut label in place; every quote is verbatim from the physician’s own post.