GU Medical Oncologist, MedStar Georgetown University Hospital/Washington Hospital Center
Washington, DC
Joined October 2017
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Nicholas I Simon, MD MSc retweeted
Outcomes from 1027 pc-RPLNDs in NSGCT:
• Residual mass size correlates with higher rates of teratoma and yolk sac tumor
• Primary tumor histology associated with RPLND pathology
🔗 doi.org/10.1016/j.annonc.202…
@RichMatulewicz @SpiessPhilippe @SpiessPhilippe @drgaganprakash @LuisMedinaMD @npaesa @CMercinelli @dramandeeparora @CurtisPettaway1 @MDAndersonNews @MoffittNews @TataMemorial @MUSC_UroOnc @AmerUrological @UroOnc @SUO_YUO @CAU_URO @AndreaNecchi @orchidcancer @ERN_eUROGEN @EauPatient @JadChahoud
Nicholas I Simon, MD MSc retweeted
Here is Version 2.0 of when to hold systemic tx during RT. Updated & w 3 additional drug categories (ADCs, CDK4/6 inhibitors, PARPi).
More details on newer drugs in 🧵 below.
Please use this version as reference & thanks for all input/experience crowdsourcing! (1/3)
Nicholas I Simon, MD MSc retweeted
🚨 Can we delay ADT in oligometastatic HSPC… without compromising control?
The phase 2 BULLSEYE trial answers this with radioligand therapy.
👥 Study population:
Biochemically recurrent, PSMA+ oligometastatic HSPC
- ≤5 mets, PSA DT <6 months
- Not candidates for surgery/SBRT
- ADT-naïve
⚡ Trial design:
🟣 ¹⁷⁷Lu-PSMA-617 (2–4 cycles)
vs
⚪ Deferred ADT (active monitoring)
📊 Key results:
🔥 Progression at 30 weeks: 7% vs 93%
🔥 Median PFS: 25 vs 5 months
🔥 HR 0.07 (p<0.0001)
📉 PSA responses:
- ≥50% decline: 83% vs 0%
- ≥90% decline: 52%
- Complete biochemical response: 24%
🛡️ Safety:
Mostly grade 1–2
- Grade 3 AEs: rare (dry eyes 3%, lymphopenia 10%)
- No grade 4 toxicity or treatment-related deaths
💡 Takeaway:
Radioligand therapy can dramatically delay progression and postpone ADT in selected oligometastatic HSPC patients.
But:
Small phase 2 + crossover design → not practice-changing yet
👉 A glimpse of a future where we treat early metastatic disease without hormones?
🔖 Save this for clinic discussions
📖 Full paper in comment ⬇️
#OncoTwitter #MedTwitter #ProstateCancer #NuclearMedicine @OncoAlert @myesmo @esmo_open @asc
Nicholas I Simon, MD MSc retweeted
[177Lu]-PSMA-617-PSMA-617 in oligometastatic hormone sensitive prostate cancer (BULLSEYE): an open-label, randomised, phase 2 study - The Lancet Oncology thelancet.com/journals/lanon…
Nicholas I Simon, MD MSc retweeted
📬 The Milan Consensus paper on Clinical CR definition & Endpoints for next-gen bladder-sparing trials is out in @JCO_ASCO @ASCO | following the @SanRaffaeleMI #GURetreat24
Co-sponsored by @IBCG_BladderCA @GTumors
It was a tremendous multidisciplinary effort involving friends/KOL from various fields, pt advocates @BladderCancerUS @WorldBladderCan Pharma Industries & @FDA #EMA proving insights
✅ cCR should be rigorously based on imaging + biopsy + urinary citology
✅cCR still immature as primary endpoint for registration trials (good for esploratory studies)
✅ EFS good for registration trials
✅ EFS should capture ANY type of event including HG bladder relapses
🛜 role of biomarkers (ctDNA/utDNA) still to conceive in this clinical setting but likely to become the next 🧩
@MyUniSR @UroDocAsh @SpiessPhilippe @sonpavde #MattGalsky @#bladdercancer #endpoints #clinicalresearch @urotoday @OncLive @OncoAlert @Larvol
Nicholas I Simon, MD MSc retweeted
#BCANTT25 proud of our Medical Oncology fellow Miles Hsu who received the the 2025 John Quale Travel award for our work in the development of a clinical trial for bladder preservation in MIBC. Congratulations to him and to all the outstanding fellows!
@BladderCancerUS
Nicholas I Simon, MD MSc retweeted
Opening soon at the NIH!! E-VIRTUE, A Phase 2 Trial of Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors. @apolo_andrea @theNCI @NicholasISimon @DrAndreKydd @SaadAtiq24 doi.org/10.1080/14796694.202…
Nicholas I Simon, MD MSc retweeted
Standing in for Dr Simon and @apolo_andrea for our poster at #GU25 @ASCO @ALLIANCE_org regarding rare cancer treatment preferences , the right answer, we need trials!
Nicholas I Simon, MD MSc retweeted
We have several accruing #ClinicalTrials for patients with #SmallCell #BladderCancer
1. #Lurbi +/- #Avelumab LASER
clinicaltrials.gov/study/NCT…
2. #SG +/- #Atezo SMART
clinicaltrials.gov/study/NCT…
3. #CaboNivoIpi ICONIC
clinicaltrials.gov/study/NCT… [email protected] / ☎️240-760-6006
Nicholas I Simon, MD MSc retweeted
Happy holidays from the NCI #BladderCancer Research Team! @nciccr_gmb @NCICCR_MOS @NCICCR_UroOnc @theNCI
Nicholas I Simon, MD MSc retweeted
Calling GU junior faculty & fellows! 📣 Apply for the 2025 GU Early Career Thought Leaders conference in Philadelphia 3/6-3/8, led by me & @zklaassen_md. Secure your spot for 2 days of professional development & networking: forms.gle/jMG7iKfAYomuadMM9 @OncoAlert @SUO_YUO #SUO24
Nicholas I Simon, MD MSc retweeted
Patient Preferences for First-Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma. What is most important to patients regarding their experiences of disease burden and treatment #BladderCancer @NicholasISimon link.springer.com/article/10…
Nicholas I Simon, MD MSc retweeted
Very proud of this #ClinicalTrial of Cabozantinib/Nivolumab #CaboNivo & Cabozantinib/ Nivolumab/Ipilimumab #CaboNivoIpi published @JCO_ASCO, that includes #rareGUtumors & took years to complete but laid the foundation for many future trials in oncology gcc02.safelinks.protection.o…
Nicholas I Simon, MD MSc retweeted
A study in BMJ Oncology suggests MMR-D/MSI-H urothelial cancer may confer high sensitivity to immunotherapy. This could spare patients the morbidity of radical surgery and the toxicities of chemotherapy.
@apolo_andrea @EliasChandran @GMIannantuonoMD
bmjoncology.bmj.com/content/…
Nicholas I Simon, MD MSc retweeted
Great audience participation in #AUA24 #UTUC course with @NicholasISimon @HongTruongMD Jonathan Coleman. Much progress and much on the horizon! @AmerUrological @PSH_Urology @theNCI @MSKCancerCenter
Nicholas I Simon, MD MSc retweeted
This Friday at @asco #GU24 Dr. Andrea Apolo @apolo_andrea @nciccr_gmb @NCIResearchCtr will present the results from the phase 3 AMBASSADOR of adjuvant Pembro in urothelial carcinoma @ALLIANCE_org
Nicholas I Simon, MD MSc retweeted
Congratulations to Dr. Apolo @apolo_andrea @theNCI and team.
Positive findings from @ALLIANCE_org A031501 (AMBASSADOR) trial for patients with muscle-invasive urothelial cancer. To learn more, visit bit.ly/A031501-Interim #NCI #NCTN #CancerResearch @BladderCancerUS #bladdercancer
Nicholas I Simon, MD MSc retweeted
We have a fantastic team of rising ⭐️s @EliasChandran @GMIannantuonoMD @NicholasISimon @NCIResearchCtr presenting our #BladderCancer posters on 1]mismatch repair deficiency & MSI 2]Olaparib biomarker-selected TPS 3]M7824 +NHS-IL12 +/-XRT study 4] AI with PET/CT @ASCO #ASCO23
It is great to be between two young rising stars in GU oncology working at @nciccr_gmb 🔥🔝
@EliasChandran @NicholasISimon
#ASCO2023
Nicholas I Simon, MD MSc retweeted
We discuss the triple combination of Nivolumab + Ipilimumab + Cabozantinib in Advanced #RenalCellCarcinoma: Results from a Discontinued Arm of the Phase 3 #CheckMate9ER @EliasChandran @GMIannantuonoMD @NicholasISimon @urotoday urotoday.com/recent-abstract…