🚨 FDA Approves capivasertib Plus Abiraterone as First Targeted Therapy for PTEN-Deficient Metastatic Hormone-Sensitive Prostate Cancer Source AstraZeneca buff.ly/ldFb96p The FDA has approved capivasertib in combination with abiraterone and prednisone as the first targeted therapy for patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive #ProstateCancer . Approval was based on the Phase III CAPItello-281 trial, which demonstrated a 19% reduction in the risk of radiographic progression or death and improved median radiographic progression-free survival by 7.5 months. The decision also highlights the growing importance of biomarker-driven treatment and PTEN testing in advanced prostate cancer. @montypal @crisbergerot @DrDanielHeng @apolo_andrea @DrChoueiri @PGrivasMDPhD @TiansterZhang @HHammersMD @ravikanesvaran @neerajaiims @amerseburger @sonpavde @drenriquegrande @scserendipity1 @Silke_Gillessen @EfstathiouEleni @tompowles1 @BraunMDPhD @nataliagandur @cdanicas @brian_rini @AOmlin #OncoAlertAF @nataliagandur @realbowtiedoc @Onco_Cifu88 @scocmem

Dear Colleagues in #Prostate Cancer Introducing #APCCC26 Live from Lugano🇨🇭with @OncoAlert RT ADT ± ARPI in high-risk localized prostate cancer—where do we stand? Drs. Bertrand Tombal, Christopher Sweeney, and Jeff Michalski discuss patient selection, biomarkers, reimbursement challenges, pelvic nodal RT, and the evidence shaping treatment intensification. in this video: 👇 How should ARPIs be integrated into practice? Series Faculty @BertrandTOMBAL @ChrisSweens1 @jmmrad @drjefstathiou @CaPsurvivorship @LoebStacy @charlesryanmd @AarmstrongDuke @Ecastromarcos @LVM_Walz @piet_ost @Nicola_Fossati @AnthonyMJoshua @Prof_Nick_James @VedangMurthy @AttardLab @Silke_Gillessen @AOmlin Pinging @AmandaNizamMD @scocmem @nataliagandur @gu_onc @tompowles1 @amerseburger @brian_rini @declangmurphy @cdanicas @neerajaiims

Construction and external validation of radiomics models to detect primary prostate cancer with machine learning: a multicenter study based on 68Ga-PSMA PET/CT sciencedirect.com/science/ar… Study evaluated machine learning–based radiomics models using 68Ga-PSMA PET/CT to noninvasively detect #ProstateCancer in 609 patients. An XGBoost-derived radiomics model combined with SUVmax demonstrated good diagnostic performance, achieving AUCs up to 0.921 for clinically significant prostate cancer and maintaining strong accuracy across external validation cohorts. These findings suggest that PSMA PET/CT radiomics could help assess prostate cancer risk and guide biopsy decisions. @OncoAlert 🚨 @Silke_Gillessen @AOmlin @weoncologists

Current Status of PSMA-Targeted Agents Based on Small Molecules for Prostate Cancer in Preclinical Studies link.springer.com/article/10… PSMA is a validated target for #ProstateCancer imaging and radioligand therapy (RLT), with urea-based small-molecule ligands showing favorable pharmacokinetics, tumor penetration, and radiolabeling properties. Recent preclinical efforts aim to improve efficacy through ligand optimization, radionuclide selection, and pharmacokinetic enhancements. Strategies such as albumin-binding moieties and linker modifications seek to increase tumor uptake while reducing off-target toxicity. Therapeutic radionuclides, including lutetium-177, actinium-225, astatine-211, and iodine-125, offer complementary mechanisms of tumor cell destruction. @OncoAlert 🚨 @Silke_Gillessen @AOmlin @weoncologists

The ‘Prostate Cancer Screening for People at Genetic Risk of Aggressive Disease’ (PATROL) study Protocol bjui-journals.onlinelibrary.… The PATROL study is a multicenter, prospective screening trial evaluating #ProstateCancer early detection in individuals carrying germline 🧬 pathogenic variants linked to increased prostate cancer risk. The study assesses the predictive value of age-adjusted PSA 🧪 thresholds and prostate MRI for detecting clinically significant disease. Participants undergo annual screening, with biopsies triggered by predefined PSA levels or clinical concern. PATROL also collects biospecimens, clinical outcomes, and patient-reported data to advance biomarker development and risk-stratified screening strategies. @OncoAlert 🚨 @Silke_Gillessen @AOmlin @weoncologists

Canadian Cancer Trials Group (CCTG) study PR21 (PLUDO): Results of crossover treatment from a randomized trial of 177Lu-PSMA-617 (LuP) vs docetaxel (DOC) in patients with metastatic castration-resistant prostate cancer (mCRPC). asco.org/abstracts-presentat… The phase II PLUDO trial 🇨🇦compared first-line lutetium-177 PSMA (LuP) versus docetaxel 💊(DOC) in chemotherapy-naïve, PSMA-positive mCRPC. While first-line rPFS was similar, overall survival favored DOC in the intention-to-treat population. Among patients who crossed over at progression and received both therapies, no differences were observed in second-line rPFS, rPFS2, or OS. These findings suggest the OS imbalance was likely driven by unequal crossover rates, highlighting the importance of receiving both treatments. #ProstateCancer @lhscradonc @sebastienhotte @JustinLeeMD @LuciaNappi4 @DiMariaJiang @Yipilimumab @francoisbenard @OncoAlert 🚨 @Silke_Gillessen @AOmlin @weoncologists

Dear Colleagues, Introducing a New Series from @APCCC_Lugano : #APCCC26 LIVE from Lugano In this Video Dr. Chris Sweeney , Tombal and Michalski discuss ⭐️RT ADT /- in high risk localized disease @BertrandTOMBAL @ChrisSweens1 @jmmrad @Silke_Gillessen @AOmlin @OncoAlert @DrYukselUrun @nataliagandur @fabioturco92 @UrsulaVogl @SScagliarini @Tylersbrt @neerajaiims @amerseburger @Cdanicas @EAntonarakis @KOSJ12 @DrRanaMcKay @stefanofanti4 @mirrorsmed @profkhermann @dr_coops @_ShankarSiva @DrSpratticus @scocmem @AmandaNizamMD @EUplatinum

Cognitive effects of darolutamide vs enzalutamide: Results of ARACOG (AFT-47), a randomized clinical trial from the Alliance for Clinical Trials in Oncology asco.org/abstracts-presentat… The phase 2 ARACOG trial randomized 111 patients with mHSPC, mCRPC, or nmCRPC to darolutamide (DAR) or enzalutamide 💊 (ENZ) and prospectively evaluated cognitive outcomes using the CANTAB platform. At 24 weeks, DAR was associated with significantly less cognitive 🧠 📉 decline than ENZ in the maximally changed cognitive domain (-15.8% vs -36.1%; p=0.009). Cognitive performance appeared stable or improved with DAR, suggesting a learning effect, whereas ENZ showed mild decline. Notably, all treatment crossovers occurred from ENZ to DAR, primarily due to objective or subjective cognitive deterioration, supporting a more favorable cognitive profile for DAR. #ProstateCancer @CaPsurvivorship @CaPsurvivorship @danielkwonmd @deepak_kilari @_StuartBloom @PrafulRavi1 @kvballman @EAntonarakis @charlesryanmd @OncoAlert @Silke_Gillessen @AOmlin @weoncologists

Phase 2 multicenter trial of chemoimmunotherapy for patients with neuroendocrine or aggressive variant metastatic prostate cancer (CHAMP). asco.org/abstracts-presentat… The phase II CHAMP trial combining cabazitaxel carboplatin with dual checkpoint blockade (ipilimumab/nivolumab) met its primary endpoint in metastatic NEPC/AVPC, achieving a remarkable 78% 6-month rPFS rate and a median rPFS of 12 months. This heavily pretreated cohort included 75% of patients with visceral metastases. Importantly, toxicity was manageable with no treatment-related deaths, and 2 patients remain disease-free off therapy beyond 30 months. These data provide a strong rationale for randomized trials of chemoimmunotherapy in NEPC/AVPC. #ProstateCancer @AarmstrongDuke @DrLaurenFHoward @DrChrisHoimes @LandonBrownMD @cnsternberg @aaparicioMD @BSiddiquiMD @Daniel_J_George @OncoAlert 🚨 @Silke_Gillessen @AOmlin @weoncologists

PARP and Androgen-Signaling Inhibition plus ADT in Metastatic Prostate Cancer : TALAPRO3 nejm.org/doi/abs/10.1056/NEJ… In metastatic androgen pathway modulation–sensitive (APMS) #ProstateCancer with HRR gene alterations, talazoparib enzalutamide was compared with enzalutamide alone in a phase 3, double-blind trial (~600 patients). 📊 Efficacy At 3 years, imaging-based PFS was 77% vs 56%, translating to a 52% reduction in risk of progression or death (HR 0.48; P<0.001). Interim OS showed a numerical trend: • 78% vs 72% (HR 0.77; 95% CI 0.56–1.04) ⚠️ Safety • Serious AEs: 42% vs 32% • Grade ≥3 anemia: 51% • Two treatment-related deaths in the talazoparib arm 💡 Take-home: Adding talazoparib significantly improves PFS in HRR-altered APMS prostate cancer, supporting earlier use of PARP inhibition, but with increased hematologic toxicity. @neerajaiims @AzadOncology @quimmateo @nealshore @cvulsteke @OncoAlert @Silke_Gillessen @AOmlin @weoncologists

Dear Colleagues at #ASCO26 A great way to end this final day of the meeting that with a presentation straight from the Podium to your feed. @OncoAlert proudly presents Dr. Roger Von Moos 🇨🇭who just presented Abs 1004 at ASCO: Prevalence of symptomatic skeletal events (SSE) with reduced denosumab (Dmab) dose density (every 12 weeks versus every 4 weeks): A randomized phase III non-inferiority trial SAKK 96/12 REDUSE. The phase III SAKK 96/12 REDUSE trial randomized 1,380 patients with bone-metastatic breast cancer or castration-resistant prostate cancer to denosumab 120 mg every 4 weeks or, after a 3-month loading phase, every 12 weeks. The reduced-frequency schedule was non-inferior for preventing symptomatic skeletal events, with similar efficacy and lower rates of hypocalcemia and osteonecrosis of the jaw. These findings support every-12-week denosumab as a new standard of care, reducing toxicity, treatment burden, and costs. @Silke_Gillessen @RothschildSacha @DrChoueiri 🇺🇸 @hoperugo 🇺🇸 @matteolambe 🇮🇹 @TiansterZhang 🇺🇸 @CathyEngMD 🇺🇸 @stolaney1 🇺🇸 @montypal 🇺🇸 @tompowles1 🇬🇧 @brian_rini 🇺🇸 @cdanicas 🇪🇸 @NiuSanford 🇺🇸 @amerseburger 🇩🇪 @GlopesMd 🇺🇸 @Icro_Meattini 🇮🇹 @PGrivasMDPhD 🇺🇸 @DrYukselUrun 🇹🇷 @nataliagandur 🇦🇷 @ElisaAgostinett 🇧🇪 @HHorinouchi 🇯🇵 @realbowtiedoc 🇺🇸 @to_be_elizabeth 🇮🇹 @UOzkerim 🇹🇷 @p_ciracimd 🇮🇹 @DrVilmaPBarcia 🇪🇸 @DraMartinezLago 🇪🇸 @DrMirallas 🇺🇸 @GaiaGriguolo 🇮🇹 @MarioBalsaMD 🇪🇸 @scocmem 🇬🇧 @AmandaNizamMD 🇺🇸 & @weoncologists 🇺🇸 @APCCC_Lugano @AOmlin

Dear Colleagues at #ASCO26 Thank you for joining us and reminding you that THE COMPLETE ONCOALERT NEWSLETTER with ALL of our picks from #ASCO26 comes out this Thursday and conveniently to your Inbox REGISTER HERE 👉buff.ly/Ax3E7T7 @DrChoueiri 🇺🇸 @hoperugo 🇺🇸 @matteolambe 🇮🇹 @TiansterZhang 🇺🇸 @CathyEngMD 🇺🇸 @stolaney1 🇺🇸 @montypal 🇺🇸 @tompowles1 🇬🇧 @brian_rini 🇺🇸 @cdanicas 🇪🇸 @NiuSanford 🇺🇸 @amerseburger 🇩🇪 @GlopesMd 🇺🇸 @Icro_Meattini 🇮🇹 @PGrivasMDPhD 🇺🇸 @DrYukselUrun 🇹🇷 @nataliagandur 🇦🇷 @ElisaAgostinett 🇧🇪 @HHorinouchi 🇯🇵 @realbowtiedoc 🇺🇸 @to_be_elizabeth 🇮🇹 @UOzkerim 🇹🇷 @p_ciracimd 🇮🇹 @DrVilmaPBarcia 🇪🇸 @DraMartinezLago 🇪🇸 @DrMirallas 🇺🇸 @GaiaGriguolo 🇮🇹 @MarioBalsaMD 🇪🇸 @scocmem 🇬🇧 @AmandaNizamMD 🇺🇸 & @weoncologists 🇺🇸

🚨 From #ASCO26 to NEJM 🚨 Perioperative apalutamide ADT improves outcomes in patients with newly diagnosed high-risk localized or locally advanced #ProstateCancer in the phase 3 #PROTEUS trial. 🧑‍⚕️ 2,109 patients were randomized to receive perioperative ADT apalutamide or placebo before and after radical prostatectomy. Key findings: ✅ Higher pathological complete/minimal residual disease response rates (8.9% vs 1.0%) ✅ Improved 5-year metastasis-free survival (78.2% vs 73.5%) ✅ Better event-free survival ✅ Delayed need for subsequent anticancer therapy ⚠️ Grade 3–4 adverse events were more frequent with apalutamide, driven mainly by increased rash. 📖 NEJM: buff.ly/BAj6DlM #ProstateCancer @marty_gleave @EfstathiouEleni @DrPaulNguyen @Albert0Briganti @ProfHadaschik @ashleyrossmdphd @adamkibel_uro @OncoAlert 🚨 @Silke_Gillessen @AOmlin @weoncologists

Dear Colleagues at #ASCO26 @OncoAlert 🚨Straight from the podium to your Feed, Proud to have @AarmstrongDuke 🇺🇸from Duke Cancer Institute discussing: Phase 2 multicenter trial of chemoimmunotherapy for patients with neuroendocrine or aggressive variant metastatic prostate cancer (CHAMP). Just presented at #ASCO26 The phase II CHAMP trial demonstrated promising activity of cabazitaxel, carboplatin, ipilimumab, and nivolumab in metastatic neuroendocrine and aggressive-variant #ProstateCancer . The regimen achieved a 78% 6-month radiographic PFS rate and median rPFS of 12 months, outperforming historical platinum chemotherapy benchmarks, with manageable toxicity and durable responses in select patients. @AarmstrongDuke @DrLaurenFHoward @DrChrisHoimes @LandonBrownMD @cnsternberg @aaparicioMD @BSiddiquiMD @Daniel_J_George Ping OncoAlert Faculty @montypal @crisbergerot @DrDanielHeng @apolo_andrea @DrChoueiri @PGrivasMDPhD @TiansterZhang @HHammersMD @ravikanesvaran @neerajaiims @amerseburger @sonpavde @drenriquegrande @scserendipity1 @Silke_Gillessen @EfstathiouEleni @tompowles1 @BraunMDPhD @nataliagandur @cdanicas @brian_rini @AOmlin @yekeduz_emre @DrYukselUrun @scocmem @AmandaNizamMD @weoncologists

Perioperative Apalutamide in High-Risk Localized Prostate Cancer : PROTEUS From #ASCO26 to NEJM buff.ly/BAj6DlM A phase 3 trial randomized 2,109 patients with newly diagnosed high-risk localized or locally advanced #ProstateCancer to perioperative ADT plus apalutamide💊 or placebo before and after radical prostatectomy. Apalutamide significantly improved 📈 pathological response rates (8.9% vs. 1.0%) and 5-year metastasis-free survival (78.2% vs. 73.5%), while also improving event-free survival and delaying subsequent treatment. Grade 3–4 adverse events were more frequent, mainly due to increased rash. @marty_gleave @EfstathiouEleni @DrPaulNguyen @Albert0Briganti @ProfHadaschik @ashleyrossmdphd @adamkibel_uro @montypal @crisbergerot @DrDanielHeng @apolo_andrea @DrChoueiri @PGrivasMDPhD @TiansterZhang @HHammersMD @ravikanesvaran @neerajaiims @amerseburger @sonpavde @drenriquegrande @scserendipity1 @Silke_Gillessen @EfstathiouEleni @tompowles1 @BraunMDPhD @nataliagandur @cdanicas @brian_rini @AOmlin @yekeduz_emre @DrYukselUrun @realbowtiedoc @scocmem @AmandaNizamMD

SO WHATS HAPPENING IN GU at #ASCO26 There are no better two people to answer that than OUR @OncoAlert 🚨GU Faculty/friends @brian_rini 🇺🇸and @tompowles1 🇬🇧(AKA @Uromigos ) to guide us through that. Coming Straight from Beautiful Lake Lugano in Switzerland ( #APCCC26) Brian and Tom guide us to the amazing things we have seen and are expecting!! #ProstateCancer #KidneyCancer #BladderCancer @lalaniMD @AmandaNizamMD @DrKarineTawagi @nataliagandur @ReneeSaliby @NazliDizman @scocmem @uromigosjapan @TresUramigas @weoncologists Ping #OncoAlert GU Faculty @montypal @crisbergerot @DrDanielHeng @apolo_andrea @DrChoueiri @PGrivasMDPhD @TiansterZhang @HHammersMD @ravikanesvaran @neerajaiims @amerseburger @sonpavde @drenriquegrande @scserendipity1 @Silke_Gillessen @EfstathiouEleni @tompowles1 @BraunMDPhD @nataliagandur @cdanicas @AOmlin #OncoAlertAF @FernandoOnco @realbowtiedoc @Erman_Akkus @JankovicK @MarioBalsaMD @UOzkerim

JUST OUT at #ASCO26 with a concomitant Publication in the New England Jouranal of Medicine: TALAPRO 3 :PARP and Androgen-Signaling Inhibition plus ADT in Metastatic Prostate Cancer by our dear friend and OncoAlert founding faculty @neerajaiims 🚨 buff.ly/gk9AuvF In this phase 3 trial of patients with metastatic androgen pathway modulation–sensitive #prostateCancer and homologous recombination repair gene alterations, adding talazoparib to enzalutamide significantly improved imaging-based progression-free survival versus enzalutamide alone (3-year rates: 77% vs. 56%; HR 0.48, P<0.001). An interim overall survival analysis favored talazoparib but was not definitive. Toxicity was higher with talazoparib, particularly grade ≥3 anemia, with two treatment-related deaths reported. @neerajaiims @AzadOncology @quimmateo @nealshore @cvulsteke @montypal @crisbergerot @DrDanielHeng @apolo_andrea @DrChoueiri @PGrivasMDPhD @TiansterZhang @HHammersMD @ravikanesvaran @neerajaiims @amerseburger @sonpavde @drenriquegrande @scserendipity1 @Silke_Gillessen @EfstathiouEleni @tompowles1 @BraunMDPhD @nataliagandur @cdanicas @brian_rini @AOmlin @yekeduz_emre @DrYukselUrun @nataliagandur @realbowtiedoc @AmandaNizamMD @scocmem

Independent validation of a model to predict early favorable PSA response (NADIR model) in enzalutamide-treated patients of the ARCHES trial. To be Presented at #ASCO26 asco.org/abstracts-presentat… Independent validation of the NADIR model in enzalutamide-treated patients from the 🏹ARCHES trial demonstrated strong performance in predicting early favorable PSA response in metastatic hormone-sensitive #ProstateCancer . The model achieved an AUC of 0.80 and effectively stratified patients by PSA response and overall survival. Patients in lower prediction tertiles experienced significantly worse survival outcomes. These findings support the NADIR model as a promising prognostic tool for patients receiving androgen receptor pathway inhibitor therapy. @soumyajitroy @AarmstrongDuke @neerajaiims @DrRanaMcKay @AmarUKishan @PBarataMD @JasonBrownMDPhD @SpyrosBasourako @WallisCJD @DrSpratticus @NicholasZaorsky Neal Shore ( @CURCMB ) @OncoAlert 🚨 @Silke_Gillessen @AOmlin @weoncologists

Michael Morris from @MSKCancerCenter and @AarmstrongDuke join us to discuss the new Prostate Cancer Working Group 4 (PCWG 4) criteria including updates in nomenclature, use of PSMA PET, molecular markers and PROs. spotifycreators-web.app.link…

Prevalence of symptomatic skeletal events (SSE) with reduced denosumab (Dmab) dose density (every 12 weeks versus every 4 weeks): A randomized phase III non-inferiority trial SAKK 96/12 REDUSE. Abstract 1004 to be presented at #ASCO26 asco.org/abstracts-presentat… The SAKK 96/12 REDUSE trial demonstrated that denosumab administered every 12 weeks after an initial loading phase was non-inferior to standard every-4-week dosing in patients with 🦴bone-metastatic #BreastCancer or castration-resistant #ProstateCancer . Time to symptomatic skeletal events was comparable between schedules, while📉 reduced-frequency dosing resulted in lower rates of hypocalcemia and osteonecrosis of the jaw. These findings support Q12W denosumab as a new standard of care, reducing toxicity, treatment burden, and healthcare costs without compromising efficacy. @Silke_Gillessen @RothschildSacha @OncoAlert @AOmlin @weoncologists