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We have just read a Letter to the Editor from @nickva1, @alison_tree, @piet_ost that carries an implication of dishonesty, and unfaith, deliberately distorting the facts in order to criticize and mislead readers to truly understand the article .
“Oncological Outcomes Following Focal HIFU and Cryotherapy for Treatment of Nonmetastatic Prostate Cancer in the United Kingdom: An Updated Analysis of 3477 Patients from the Prospective HEAT and ICE Registries”
We firmly oppose their behavior. Our forthcoming analysis will clarify the actual content and specifically identify how they have twisted the information.
@LondonProstate1 ,@AJWLight @IP_London
Please see our letter @alison_tree @piet_ost in response to the recent Focal therapy paper in @EUplatinum
authors.elsevier.com/a/1nlq2…
@LondonProstate1 @mrsprostate @taimurShah @ASTRO_org @ESTRO_RT
Dong Nguyen retweeted
🎯 #ESMO26 Starting the Day with Excellent educational session of How to optimise care for pts receiving prostate cancer systemic therapy.
👉 @BarbaraJereczek nice presentation updating the management of HR-PC pts! 😊@OncoAlert @myESMO @APCCC_Lugano @urotoday @GuardConsortium
Dong Nguyen retweeted
While DASL-HiCaP reinforces ARPI intensification, important questions remain @Silke_Gillessen
Why positive #STAMPEDE/#DASL-HiCaP, yet not #ENZARAD? Which high-risk patients benefit most? Primary vs salvage RT? And how does #PROTEUS reshape intensification around surgery? #Enzalutamide #Apalutamide #Darolutamide
❓Different risk definitions and primary vs salvage settings complicate comparisons.
❓Who truly needs ARPI intensification, and when? What is the additive role of #RadiationTherapy and #RadicalProstatectomy
❓With PROTEUS extending the discussion to prostatectomy, better patient selection and identifying the best prognostic and predictive biomarkers reflecting specific early/local/locally advanced indications remains key
#ESMO26 #ProstateCancer #UrologicOncology @oncodaily @OncoDailyGU @urotoday
Dong Nguyen retweeted
Positive DASL-HiCaP results presented at #ESMO26 @niazi_Dr7
👍Adding #darolutamide to ADT + RT in very-high-risk #ProstateCancer improved
✅4-year MFS (95% vs 88%; HR 0.42), ✅delayed CRPC (HR 0.22)
✅increased time to subsequent hormonal therapy (HR 0.36)
All clinically meaningful benefits, while OS remains immature.
#ProstateCancer #Radiationtherapy #UrologicOncology @oncodaily @OncoDailyGU @urotoday @ChrisSweens1
Dong Nguyen retweeted
🎉 Out in @ctRO_journal
@miszczyk_marcin & @CZamboglou &
@GiuliaMarvaso84 &
@GiulioFrancoli1
✨ On behalf of @ESTRO_RT
sciencedirect.com/science/ar…
Congratulations 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
1/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 🧵
Dong Nguyen retweeted
Results 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 :
bayer.com/media/en-us/darolu…
#DASLHiCaP #ESMO2026 #ProstateCancer #Darolutamide #UroOncology
Dong Nguyen retweeted
🚨 PEACE-1: 8y FU long-term analysis
In patients receiving ADT+docetaxel (n=710), adding abiraterone delivers:
🔹mOS: 6.2 vs 4.4 years (HR 0.68)
🔹 8-yOS: 40.3% vs 27.1%
🔹 High-vol OS: HR 0.67
🔹 Low-vol OS: HR 0.74
🔹 No treatment-by-volume interaction (P=0.5552).
@OncoAlert
Dong Nguyen retweeted
Presented at #ESMO26:
In patients with muscle-invasive bladder cancer, event-free survival at 24 months was 63.5% with perioperative durvalumab plus neoadjuvant enfortumab vedotin as compared with 45.1% with surgery alone. Full phase 3 VOLGA trial results: nej.md/4z7dQFm
@myESMO
ALT A graph showing event-free survival for the durvalumab–enfortumab vedotin (EV) and control groups (intention-to-treat population).
Dong Nguyen retweeted
🚨📣📣 #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
Dong Nguyen retweeted
DASL-HiCaP #ESMO26
Very high-risk prostate ca Ph3 n=1,106
RT+ADT+Darolutamide vs placebo
MFS-CI: 5% vs 11% events | 4y 95% vs 88%
HR 0.42 (0.27-0.66) p=0.0001
Another positive study in high-risk prostate cancer, increasing the treatment options for our patients.
- @GhosnMd
@myESMO @GustaveRoussy @GRAlumni #ProstateCancer
Dong Nguyen retweeted
1/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 🧵
DASL-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
Dong Nguyen retweeted
Great discussions at #ESMO2026!
A pleasure to participate as an invited discussant in today’s Rapid Oral session on #BladderCancer.
From NMIBC to metastatic disease: ADCs, immunotherapy, biomarkers and patient-reported outcomes. The therapeutic landscape is changing rapidly!
But presenting new evidence is only part of the story. Putting results into context and critically assessing their clinical value is essential to understand what should change in daily practice.
Great to share the session with Britt Suelmann and @ProfSyedHussain.
Thank you @myESMO for the invitation and to all the investigators for their outstanding research! And above all : thank you to our patients for their trust.!
#UroOncology #GUOncology
That is correct, patients were entered as M0 by conventional imaging, and most metastases detected and contributing to MFS were identified by PSMA PET.
But this stems from the protocol amendment in April 2022: as PSMA-PET became more widely available, the investigators revised the protocol to incorporate PSMA-PET into the composite MFS endpoint.
However, by that time, the enrollment (7/2019 -6/2022) was nearly complete, so this change had little impact on randomization.
It is true that most detected metastases contributing to MFS were identified by PSMA PET, and that the number of PSMA PET scans was higher in the control arm (ADT+RP) than in the experimental arm (Apalutamide+ADT +RP).
However, the indications for scanning were identical between the two arms: 3 months after completion of adjuvant treatment and at biochemical failure (PSA ≥ 0.2), with repeat scanning thereafter if BCR occurred.
Thus, the higher number of PSMA PET scans in the control arm (ADT + RP) reflects poorer PSA control in that arm.
Some folks could argue that more frequent PSMA scanning in the control arm made MFS appear worse in that arm, because PSMA detects more metastases.
So how to be fully rigorous, the PSMA scanning schedule should therefore have been fixed and uniform across both arms.
However, this is largely unnecessary, because it would require performing PSMA scans in patients without PSA rise , especially after PSA, a group with a very low rate of MFS.
Therefore, the impact of PSMA imaging is not fixed schedule, instead, it only needs when necessary (BCF failure) , yes it might potential affect it on MFS but that is extremely small.
@ProtonStorey
Agree, @dr_coops--this addresses an important control-arm criticism. But patients entered as M0 by conventional imaging, while most detected metastases contributing to MFS were identified by PSMA PET. That distinction matters when interpreting the endpoint and applying these results to patients staged with PSMA upfront.
EFS also includes PSA recurrence, and delaying “subsequent therapy” doesn’t necessarily mean less overall treatment when the intensified strategy delivers a year of ADT+apa upfront.
The concern is letting the tail wag the dog: enthusiasm for better endpoints should be matched by evidence of a better overall treatment course. These results strengthen the case for intensification around RP (SOC is RP with selective secondary RT +/-ADT).
Cumulative hormonal exposure, postoperative RT and QoL remain central to understanding the net benefit--and to counseling patients about both surgical and RT-based options.
Ok , I will answer your question.
To determine whether EFS is a reasonable endpoint for this PROTEUS substudy, you must know the context of the trial's design.
First, it is important to emphasize that the data presented on the slide does not originate from the main PROTEUS study, but rather from a substudy.
The core difference lies in the fact that this substudy selected EFS as its primary endpoint, whereas the main study utilized MFS). This change in endpoints was implemented specifically to meet the requirements of the EMA.
Read the main PI of PROTEUS answer :
hematologyandoncology.net/fi……
Second, the rationale for this substudy stems from a limitation of the main trial.
Specifically, the main PROTEUS trial compared Apalutamide + ADT versus Placebo + ADT around the time of RP in high-risk PCa patients. This design was previously criticized for not comparing the regimen directly against the current real-world SOC, which is RP alone.
Consequently, to clarify the efficacy of treatment intensification compared to RP alone while also meeting the stringent regulatory requirements of the EMA this substudy was proposed and conducted.
The transition of the primary endpoint from MFS to EFS in the substudy was intended to align with this new comparative context.
Then , before you make an criticism, please remember that the role of the substudy is to reinforce the results of the main study in evaluating the perioperative Apalutamide + ADT regimen. That is
The main study establishes the isolated efficacy of Apalutamide, and the substudy elucidates the efficacy of Apalutamide + ADT when directly compared against the SOC.
Therefore, to gain the most comprehensive and objective perspective on the value of the PROTEUS regimen, any assessments, evaluations, or criticisms must be based on a harmonious combination of the results from both the main study and this substudy.
@declangmurphy , @Albert0Briganti
Presentation of ProteusEFS results:
Do you think it’s possible to interpret a bPFS at 36 months, when the median testosterone recovery is 20 months ?
I would say people in the ADT+ APA are still castrated.
@piet_ost @PaulSargos @_ShankarSiva @PBlanchardMD @DrSpratticus
I agree that that the EFS endpoint is directly influenced by ADT: ADT delays the onset of biochemical failure, thereby artificially prolonging EFS partly due to a transient PSA-suppression effect. That’s lead-time/PSA-suppression bias.
However, this represents a necessary compromise to meet the requirements of different regulatory agencies.
Consequently, the study design cleverly maintained MFS as the primary endpoint for the main study (meeting FDA requirements) and EFS for the substudy (meeting EMA requirements).
To evaluate, the evidence derived from combining both studies demonstrates consistency in supporting the efficacy of the Apalutamide + ADT regimen:
• In the substudy: EFS was heavily influenced by ADT, yet still demonstrated a clear benefit in favor of the Apalutamide + ADT arm (with an HR of 0.38).
• In the main study: when both arms received ADT (thereby eliminating the confounding factor of ADT), the EFS results remained consistent and favored the Apalutamide + ADT arm (with an HR of 0.71).
So, it is evident that the magnitude of the EFS benefit is driven by ADT, as reflected in the discrepancy between HR 0.38 (substudy) and HR 0.71 (main study).
However, the direction of the effect is entirely consistent and uniformly supports the benefit of the Apalutamide + ADT regimen.
Dong Nguyen retweeted
DASL-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
Dong Nguyen retweeted
Great to finally see the results of the #PROTEUS substudy comparing #perioperative Apa+ADT with the true SOC (RP w/o neoadjuvant treatment) - which should at least reduce some concerns related to the active comparator with ADT in the main study that didn’t reflect what we actually do as a standard in HR patients #ESMO26
Outcomes in all #endpoints significant improved
✅EFS: HR 0.38, 95% CI 0.26–0.55
✅MFS: HR 0.49, 95% CI 0.26–0.90
✅TT 1st Sub Rx: HR 0.29, 95% CI 0.20–0.43
The question remains which of these outcomes are most clinically relevant and meaningful #PROTEUS #ProstateCancer #UrologicOncology #Apalutamide #RadicalProstatectomy @oncodaily @OncoDailyGU @urotoday @Albert0Briganti @JNJInnovMed
Dong Nguyen retweeted
Full #ESMO26 @urotoday article 👇
I included as many details as possible that were provided in the presentation
urotoday.com/conference-high…
Dong Nguyen retweeted
ctDNA analysis is an increasingly utilised prognostic tool in muscle invasive bladder cancer. In VOLGA 78% of the muscle invasive bladder cancer patients were ctDNA positive at baseline which was prognostic. Also, the combination of perioperative durvalumab and neoadjuvant EV cleared ctDNA in 60% of patients (using the Natera Genome assay which has increased sensitivity). Clearance was associated with much better outcomes. #ESMO26
