Preoperative anemia (PA) and red blood cell transfusion (RBT) are associated with decreased survival in several cancers. In muscle-invasive bladder cancer (MIBC), anemia is frequent and may be worsened by neoadjuvant chemotherapy (NAC). While PA’s impact is known in patients undergoing cystectomy without NAC, its prognostic value in the current multimodal approach remains unclear. We retrospectively analyzed patients with cT2–T4 N0–N2 M0 MIBC treated with cisplatin-based NAC followed by radical cystectomy and lymphadenectomy between 2011 and 2022. We recorded the lowest hemoglobin value from NAC start to surgery (PA), use of RBT during NAC, and iron or vitamin B9/B12 supplementation. This monocentric cohort included 175 patients (77
598 Background: Follow-up of patients with germ-cell tumours (GCT) relies on monitoring serum markers (SM) including alpha-fetoprotein (AFP), human chorionic gonadotropin (hCG), and lactate dehydrogenase (LDH). Instances of benign, non-GCT related elevation of AFP have been reported as case reports. Identifying such occurrences is crucial to prevent misdiagnosis of residual disease and subsequent overtreatment, which may lead to increased morbidity. Methods: We conducted a national retrospective study in nine GETUG institutions. Patients with isolated persistent elevation of AFP levels above the normal range after receiving curative treatment for GCT without detectable disease on CT scan imaging were identified. Data on patient characteristics, treatment response, changes in SM values over time, and serum AFP levels from first- and second-degree relatives were collected. Familial AFP elevation was defined as AFP levels above the normal range in at least one first- or second-degree relative. Results: From June 1990 to April 2024, 31 patients were identified. Median age was 35 years (range, 19 to 49 years). 15 patients (48%) had pure seminoma, and 16 (52%) had non-seminomatous GCT. Overall, 19 patients (61%) had a clinical stage I disease, 17 (23%) had stage II, and 5 (16%) had stage III. No patient had a history of chronic alcoholism or consumption of medications with hepatic toxicity. Median AFP level after curative treatment was 12 ng/mL (range, 8.8 to 36 ng/mL). No evidence of disease was found on CT scan. An ultrasound examination of the contralateral testis and an FDG-PET/CT were performed in 15 (48%) and 7 patients (23%), respectively, also showing no evidence of disease. Serum AFP levels from family relatives were obtained for 14 patients (45%), with a family elevation identified for 10/14 patients (71%). After a median follow-up of 35 months (range: 7-253 months), AFP levels remained elevated in all 31 patients without documented disease relapse. Conclusions: Benign and often familial elevations of serum AFP levels are rare occurrences, which can be a chance finding following curative treatment for GCT. Ultrasound examination of the contralateral testis and AFP measurement in family members are recommended. Surveillance alone is appropriate.
363 Background: Active surveillance (AS) is standard of care for low-risk and selected intermediate risk prostate cancer (PC). However, 20 to 50% of patients (pts) will ultimately require a local treatment following AS. This study aims to assess whether apalutamide (APA) could reduce the proportion of patients requiring local treatment within 3 years. Methods: Multicentric, open label, non-comparative phase II study conducted in pts with low to intermediate risk PC randomized between APA 6 months (240 mg/d) with AS vs AS alone. The primary objective was to evaluate the proportion (π) of patients requiring a local treatment in the APA+AS arm with the aim of rejecting the null hypothesis π ≥ 30% with a 5% significance level, using an exact one-sided test for proportions. The secondary objectives were to assess pathological progression (pPFS: Gleason score or a higher % of positive cores against baseline), PSA progression (bPFS: rise in PSA levels ≥ 25%/baseline) and APA safety. Results: Between 09/2017 and 07/2021 51 pts were randomized in APA group (gp) and 40 in control (CTRL) gp. The median follow up was 36 mo (95%CI [36-37]). Median (range) age, PSA and PSA density were respectively 64 yrs (47-76), 6.8 μg/L (1.4-19.9) and 0.13 μg/L/cm³ (0.024-0.38); only 2 pts had ISUP 2 PC and 92% were d’Amico low risk group. In the APA gp, 1 did not receive APA (consent withdrawal), 4 discontinued early (<2 months) for AE and 46 received 6 mo of APA. Local treatment was performed in 37 % (90%CI, [25-50]) in APA gp and the primary objective was not achieved (p=0.88). In CTRL gp, the proportion was 44% (90% CI: [30–58]), not significantly different from APA gp (p=0.66). At 36 mo, bPFS was 55% (95% CI: [39–69]) for the APA gp vs. 42% (95% CI: [26–57]) for the CTRL gp (p= 0.07) and pPFS was 32% (95% CI: 18–46) for the APA gp vs. 11% (95% CI: [4–24]) for the CTRL gp (p= 0.01). APA toxicities (TRAEs) were observed in 98% of pts, with 14% grade 3 (G3) and 4% serious TRAEs (2% G3). Skin toxicity was observed in 30% (4%G3), 56% had asthenia/fatigue (4%G3), hypertension in 18% (4%G3), gynecomastia 62%, breast or nipple pain 36%, thyroid dysfunction 12% (2%G3), diarrhea 10%, nausea 14%, elevated transaminases in 24%. Conclusions: Apalutamide for low risk prostate cancer did not significantly reduce the proportion of patients requiring local treatment within three years. However, the results indicate improved pPFS in the APA gp. There were no new safety concerns. Clinical trial information: NCT03088124 .
Le carcinome urothélial métastatique connaît une véritable révolution thérapeutique. Après plusieurs décennies d’immobilisme avec les chimiothérapies à base de sels de platine, l’association enfortumab-védotin et pembrolizumab, validée en 2024 en première ligne sur la base de l’essai EV-302, a démontré un gain de survie sans précédent. Avec un suivi de 30 mois confirmant ce bénéfice, cette combinaison s’impose désormais comme le nouveau standard, quel que soit le statut d’éligibilité au cisplatine. Au-delà de l’enfortumab-védotin, le développement des anticorps conjugués ouvre un champ d’innovation rapide : anti-nectine-4 de nouvelle génération, anti-TROP2, et anti-HER2 tels que le trastuzumab-déruxtécan ou le disitamab védotin, y compris dans les formes HER2 « low ». Ces molécules élargissent le spectre des cibles exploitables et traduisent l’intégration progressive de la médecine de précision dans la prise en charge des carcinomes urothéliaux métastatiques. Les thérapies ciblées se renforcent parallèlement : l’erdafitinib bénéficie désormais d’un remboursement en France pour les tumeurs FGFR3 mutées, tandis que des inhibiteurs plus sélectifs (comme le LOXO-435) sont en cours d’évaluation. Enfin, des stratégies innovantes comme les anticorps bi-spécifiques ou les peptides bi-cycliques sont explorées dans des essais précoces, illustrant ce domaine en pleine expansion. Ainsi, le carcinome urothélial est désormais un modèle d’oncologie en mutation rapide, porté par l’essor des anticorps conjugués, des thérapies ciblées et de la médecine de précision, qui redéfinit les standards et ouvre de nouvelles perspectives cliniques.
Metastatic urothelial carcinoma is undergoing a major therapeutic transformation. The combination of enfortumab-vedotin and pembrolizumab, established in 2024 as the first-line standard of care, has demonstrated impressive survival benefits at 30 months of follow-up and is now the preferred regimen, regardless of cisplatin eligibility. Beyond enfortumab-vedotin, the development of antibody-drug conjugates opens up a field for rapid innovation: next-generation anti-nectin-4 agents, anti-TROP2 strategies, and anti-HER2 agents such as trastuzumab deruxtecan or disitamab vedotin, including in HER2-"low" disease. These compounds expand the range of actionable targets and illustrate the progressive integration of precision medicine into metastatic urothelial carcinoma. Targeted therapies are also gaining ground. Erdafitinib is now reimbursed in France for FGFR3-altered tumors, while more selective inhibitors (such as LOXO-435) are currently under investigation. In addition, novel approaches including bispecific antibodies and bicyclic peptides are being evaluated in early-phase trials, reflecting the dynamism of this evolving field. Altogether, metastatic urothelium carcinoma has become a paradigm of rapidly evolving oncology, driven by the emergence of antibodies-drug-conjugates, targeted therapies, and precision medicine, which are reshaping treatment standards and opening new clinical perspectives.
37 Background: PET imaging is not recommended for surveillance of mCSPC but it is used by some physicians. Little is known about surveillance for metastatic prostate cancer using PET imaging. The aim of this study was to assess the correlation between PSA response and PET imaging for mCSPC. Methods: An ambispective, multicentric, observational study, recorded PET imaging for patient’s treated with a minimum of 6 months of systemic therapy with androgen deprivation therapy (ADT) +/- androgen receptor pathway inhibitor (ARPI) +/- docetaxel for mCSPC with PSA < 0.2 ng/ml, normal CT scan and non progressive disease in bone scan. All of them had baseline evaluation with standard imaging. Results: Between August 2022 and September 2024, 57 patients (pts) with mCSPC were included, in 4 centres in France. Baseline characteristics at the time of metastatic disease were: median age of 65 years (range: 45-84), ISUP ≥4 for 63%, median PSA 22.1 ng/ml (1.6-5000ng/ml) with T≥3 in 53%. The majority of pts had low volume disease 56%, with synchronous metastatic disease for 67% and ≥ 4 bone metastases in 44%. Only 5 pts had visceral metastases. Pts were treated, by ADT + ARPI in 81%, ADT + docetaxel in 7% and triplet in 12% of cases. Patients had prostate radiotherapy (RxT) in 39% and RxT to metastatic bone lesion in 19%. The 8 months PSA was <0.2 ng/ml in 89% of pts. PET imaging was choline in 86%, PSMA in 14%. Median time between treatment initiation and PET imaging was 17 months and delay between PSA < 0.2 and PET imaging was 12 months (range: 0-32). A complete response was observed in 46 patients (81%). Non-complete responders (CR) were more frequently high volume disease (66%) and synchronous metastasis (100%), treated by ADT + ARPI alone (77%) or ADT + docetaxel (11%). Non CR were: 1 neuroendocrine progression, 1 lung cancer and 9 partial responders (2/9 progressed later). Conclusions: In patients with mCSPC, treated by ADT with ARPI and or docetaxel and with PSA < 0.2 ng/ml, a complete response is observed in 81 % when using PET imaging. The information given by PET imaging could be and additional surrogate measure to PSA response for intensification or de intensification the systemic and local treatment for mCSPC.
Antibody-drug conjugates (ADCs) are a rising therapeutic class in oncology and hematology, with eleven drugs approved by the US Food and Drug Administration as of January 2025. These "magic bullets" have a complex structure, including a monoclonal antibody, a linker, attachment sites, and a payload usually disrupting microtubules, targeting DNA, or inhibiting topoisomerase 1. By targeting specific tumor antigens, they are expected to be exquisitely effective in releasing "supertoxic" payloads inside tumor cells after intracellular trafficking. Additionally, they may exert a bystander effect, wherein the released payloads act on neighboring cells, amplifying their therapeutic impact regardless of target expression. ADCs have been game-changing drugs to treat tumors with once dismal prognoses or with previously considered unactionable targets, such as HER2-low or triple-negative breast cancer. To what extent there is room for personalized medicine to improve the toxicity/efficacy ratio remains unknown. However, there are inherent issues related to the complexity of the pharmacokinetics of ADCs and their assessments: efficacy or toxicity may be influenced by the clearance of the intact ADC, the circulating payload, or the payload-linker complex. Deciphering these multifaceted exposure-outcomes relationships for both efficacy and safety endpoints, is critical for advancing precision medicine and enabling personalized dosing strategies. To improve future developments and broaden their therapeutic scope, several strategies can be developed, including developing adequate combinations with other treatment classes (cytotoxic agents, immune-checkpoint inhibitors, oral molecular-targeted therapies). In this review, we will discuss the PK/PD aspects of ADCs and their dosing to improve their use in current and future indications.
BACKGROUND:Breast cancer (BC) is a major problem of public health in western countries. The long-term survival improved thanks to therapeutic progresses and mass screening. Mass screening is based on mammography but displays limitations. Efforts are ongoing to develop accurate and minimally invasive tools for early BC detection. Analysis of liquid biopsies is a promising option, among which the ones based on thermal denaturation profiling provide a "thermodynamic signature" of disease through analysis of plasma protein denaturation profiles. We recently developed a major technical breakthrough of differential scanning calorimetry by switching to nanoDSF (Differential Scanning Fluorimetry), more easily transferrable in clinical routine. Here, we applied it for the first time to samples form BC patients. METHODS:We retrospectively applied nanoDSF to plasma samples from 176 patients collected in two prospective clinical trials and 61 healthy controls (HC). The profiles were analyzed using four artificial intelligence (AI) algorithms. Our primary objective was to test the potential of this approach to distinguish BC versus HC samples. We also assessed its ability to distinguish early versus advanced BC, and major molecular subtypes of disease. RESULTS:The four algorithms provided predictive models displaying very good performances for distinguishing patients from HC. For example, the random forest-based model displayed 96.6% accuracy in properly classifying subjects, 99.4% sensitivity, and 88.5% specificity. These performances were not dependent on the clinicopathological characteristics of BC, and compared favorably to those of mammography-based screening. For comparison, the performances of predictive models centered on the secondary objectives (early versus metastatic stage, hormone receptor (HR)-positive versus HR-negative status, and HER2-positive versus HER2-negative status) were good, but inferior, likely because of the stronger unbalance in the number of patients in each group and of more subtle differences in thermograms between patients' groups than between patients and HC. CONCLUSIONS:We reveal the potential of nanoDSF and AI applied to plasma samples to discriminate between BC patients and HC. If these results are confirmed, such approach could represent a minimally-invasive, low risk, quick and low-cost technique, which could help to improve the screening of BC.
12028 Background: The relativesof cancer patients are at risk for developing emotional distress following the death of their loved one. The aim of this study was to analyze whether sending a condolence letter offering a post-mortem consultation with the referent oncologist to the relatives of patients who have died of cancer improve their long term reported outcomes, such as anxiety, depression and complicated grief. Methods: In this multicenter, prospective, randomized, academic trial, bereaved relatives, of cancer patients who died in hospital, were randomized between receiving a condolence letter (CL) suggesting post-mortem consultation versus no CL. At 3 months and 6 months after enrolment, anxiety (HAD-A), depression (HAD-D) and grief (Texas Revised Inventory of Grief [TRIG]) were assessed using self-administered questionnaires. Results: Of the 426 randomized relatives, 118 agreed to take part in the study, of whom 102 (49 CL, 53 no CL) completed the questionnaire 3 months after the relatives’ death and 92 (43 CL, 49 no CL) at 6 months. There was no differences in socio-demographic characteristics or history of depression between the two groups. Palliative care was involved for (69% CL, vs 52% non-CL) of patients, with no statistical difference between the two groups. At 3 months post enrolment, both anxiety and depression were significantly lower in the CL group than the non-CL group (mean HADS-A score 7.3 vs 9.4, p=0.026; mean HADS-D score: 5.4 vs 8.1, p=0.009). In addition, receiving a condolence letter was associated with less grief at patient’s death (past TRIG subscale: 20.7 vs 25.8, p<0.001), and less current grief (present TRIG subscale score: 45.7 vs 52.0, p=0.025). At 6 months, the HADS-D score was significantly lower in the condolence letter arm (mean score 5.7 vs 8.3, p=0.025), as was grief at patient’s death (past TRIG subscale: 21.5 vs 25.0, p=0.035). Only 5% of CL had a post mortem consultation. Conclusions: Sending a letter of condolence to relatives of cancer patients who have died in hospital may reduce subsequent grief, depression and anxiety in loved ones. Encouraging this widespread post mortem contact such as correspondence may be a non-drug alternative to reduce post-mortem depression and improve the bereavement process for relatives of cancer patients. Clinical trial information: NCT02861625 .
Purpose The standard follow-up for non-muscle-invasive bladder cancer is based on cystoscopy. Unfortunately, post-instillation inflammatory changes can make the interpretation of this exam difficult, with lower specificity. This study aimed to evaluate the interest of bladder MRI in the follow-up of patients following intravesical instillation. Methods Data from patients who underwent cystoscopy and bladder MRI in a post-intravesical instillation setting between February 2020 and March 2023 were retrospectively collected. Primary endpoint was to evaluate and compare the diagnostic performance of cystoscopy and bladder MRI in the overall cohort ( n = 67) using the pathologic results of TURB as a reference. The secondary endpoint was to analyze the diagnostic accuracy of cystoscopy and bladder MRI according to the appearance of the lesion on cystoscopy [flat ( n = 40) or papillary ( n = 27)]. Results The diagnostic performance of bladder MRI was better than that of cystoscopy, with a specificity of 47% (vs. 6%, p < 0.001), a negative predictive value of 88% (vs. 40%, p = 0.03), and a positive predictive value of 66% (vs. 51%, p < 0.001), whereas the sensitivity did not significantly differ between the two exams. In patients with doubtful cystoscopy and negative MRI findings, inflammatory changes were found on TURB in most cases (17/19). The superiority in MRI bladder performance prevailed for “flat lesions”, while no significant difference was found for “papillary lesions”. Conclusions In cases of doubtful cystoscopy after intravesical instillations, MRI appears to be relevant with good performance in differentiating post-therapeutic inflammatory changes from recurrent tumor lesions and could potentially allow avoiding unnecessary TURB.
e18731 Background: Oral anticancer agents (OAA) used has dramatically increased in treating genito-urinary (GU) cancer. Patients with metastatic prostate and kidney cancers, have advanced age, with comorbidities. The risks of OAA for this population with adverse effects, drug interactions and ambulatory administration must be detected, prevented and managed to decrease toxicity, improve compliance and efficacy. Here, we report the data of our comprehensive cancer center telemonitoring program named Outside the walls of the hospital (OWH), combining medical oncologist coordination, clinical pharmacist (CP) evaluations, and nurse follow-ups. Methods: Data from patients treated with OAA for advanced and metastatic prostate or kidney cancers in our center during year 2022 were retrospectively evaluated. At the start of OAA, the patients benefit from a consultation with the oncologist, clinical nurse (CN), and CP. For each drug, a standard telemonitoring program has been planned according to the patient's age and comorbidities. Results: The mean age of the patients was 68 years (44-90), 42% of the patients were over 70 years, 84% were men and 96% were in a metastatic setting. Out of 347 GU patients, 118 were included in the OWH telemonitoring program in 2022, representing 14% of the whole cancers patients enrolled in this program. Of these 118 new GU patients, 80% had a CP consultation, 76% for next generation hormonal therapy (NGHT) for advanced or metastatic prostate cancer and 24% for tyrosine kinase inhibitors (TKI) for kidney cancer. At least one drug interactions was detected for 54% of patients (61% of the NGHT and 35% of TKI). The associations was strongly discouraged for 18% because of an increase or decrease in drug concentration requiring a switch or an adaptation of dosage at the outset (statin (11 patients), oral anticoagulant (5 patients), analgesic (1 patient)). At least 1 complementary alternative medicine was used by 29% with 55% of them had an interaction with OAA. During follow-up, the frequency of consultations with CN or physician is reduced over time, in order to give priority to telemonitoring and visits to the oncologist for tumor assessment and if necessary at the request of the nurse or the patient. Conclusions: The OWH program makes it possible to limit medical visits by ensuring safe monitoring. It promotes patient empowerment and allows for medical visits when necessary, in the current context of declining medical demographic for an often elderly and fragile population.
352 Background: Active surveillance (AS) is a standard of care for low-risk prostate cancer (PC). However, 20 to 50% of patients (pts) will ultimately require a local treatment following AS. The aim of this study is to assess whether apalutamide could decrease the proportion of pts requiring local treatment within 3 years. We report the 1-year safety and quality of life analyses. Methods: multicentric phase II study conducted in patients with low to intermediate risk PC randomized between apalutamide 6 months (240 mg/d) with AS vs AS alone. Toxicity was evaluated each month during treatment and every 3 months thereafter for both arms. Quality of life (SF12) was assessed at baseline, 6 and 12 months post enrollment. Results: Patients were randomized: 51 in apalutamide and 40 in AS arm. Only 50 pts received apalutamide (one refusal). Median age was 64 yrs (47-76), median PSA 5.9 (1.5-21.5), only 2 pts had Gleason ISUP 2, 14% had >T2, the median cancer positive cores was 14.3%. The median testosterone level was 4.7 mg/l. Only 88 were available for safety analyses (48 in apalutamide arm). Maximal grades of reported adverse events during the first year were for the experimental arm: 25%, 56%, 19% and control arm: 20%, 15% 12.5% for G1, G2, G3 respectively. In the experimental arm, grade 1/2 related adverse events (AE) were cutaneous (25%) and HTA (15%), nausea 15%, diarrhea 10%, arthralgia or musculoskeletal event 17% and anemia 6%. Attention disorders were observed in 6% and hypothyroidism in 8%. The most frequent sexual dysfunctions were erectile dysfunction observed in 29% (7.5% in AS arm), gynecomastia in 60%, loss of libido in 21%, and nipple pain in 33%. One-year post enrollment, the testosterone level was 4.86 mg/l (1.5-9.8) vs 4.6 (2-7.7) in apalutamide and AS arm, respectively. Digestive symptoms were Grade 3. Related AEs were an HTA for 2 pts, rash for 1 pt, asthenia for 1 pt, erectile dysfunction for 1 pt, and decreased libido for 1 pt. One serious related AE was reported: grade 2 cerebral ischemic attack. A reduced dose was required for 16.67% of pts and 33.3% had transient discontinuation. The treatment was stopped for toxicity in 3 pts; 94% completed the 6 months of treatment. No differences were observed in physical component summary (PCS) and mental component summary (MCS) of SF12 for treatment vs AS at 6 mo (PCS: 55.1 vs 56.4; MCS 43.4 vs 41.4) and 12 mo (PCS: 53.6 vs 54.1; MCS 44.1 vs 42.9). Conclusions: This is a large randomized study evaluating apalutamide with active surveillance vs active surveillance. No new safety issues were observed and the safety profile was consistent relative to those previously described with apalutamide and castration, no falls or fracture were observed. No detrimental effect of apalutamide on QOL was observed during and after treatment. AEs are important for pts candidates for active surveillance. Clinical trial information: NCT03088124 .
La surveillance active est le traitement standard des cancers de la prostate à faible risque. Cependant, 40 à 50 % des patients vont finalement évoluer et nécessiter un traitement curatif. L'objectif de cet essai est d'évaluer si l'apalutamide peut réduire la proportion de patients ayant un traitement curatif dans les 3 ans. Nous présentons les données de tolérance et de qualité de vie à 1 an. Il s'agit d'un essai de phase II mutlicentrique incluant des patients pris en charge pour un cancer de la prostate de risque faible ou intermédiaire. Les patients ont été randomisés entre un traitement par apalutamide (240 mg/jour) pendant 6 mois associé à une surveillance active (SA) versus SA seule. Dans le cadre du protocole de SA, les patients avaient des biopsies de réévaluation annuelles pendant 3 ans. Les effets secondaires ont été évalués tous les mois pendant la période de traitement, puis tous les 3 mois. La qualité de vie a été évaluée par le questionnaire SF-12 à l'inclusion, à 6 mois et à 1 an. Quatre-vingt onze patients ont été randomisés. L'âge médian était de 64 ans [47–76], le PSA médian était de 5,9 ng/ml [1,5–21,5] ; 86 % des tumeurs étaient T1c et 96 % ISUP 1. Un total de 94 % des patients ont terminé les 6 mois de traitement, avec une réduction de dose nécessaire dans 16,7 % des cas. La fréquence des effets secondaires était de 81 % dans le bras apalutamide (versus 35 %) pour les grades 1/2, et de 19 % (versus 12,5 %) pour les grades 3. Les effets secondaires les plus fréquemment reportés étaient la dysfonction érectile (29 % versus 7,5 %) et la gynécomastie (60 %). Il n'y avait pas d'impact significatif sur la qualité de vie physique et mentale à 6 mois et 1 an. À 1 an, le taux de testostéronémie médian était de 4,86 ug/l versus 4,7 initialement. Il s'agit de la première étude prospective randomisée évaluant l'apalutamide dans le contexte de la surveillance active. Nous n'avons pas observé de nouveau signal concernant la tolérance de la molécule, et notamment pas de chute ni de fracture. Malgré un maintien de la qualité de vie, les effets secondaires sont néanmoins importants chez ces patients candidats à une surveillance active.
Correlation of mRNA for NK cell markers with prognosis in prostate cancer (public datasets).
Phenotype of NK cells infiltrating tumor prostate tissues compared to paired peripheral NK cells (pB-PC).
e17103 Background: Patient-reported outcomes measures (PROMs) allow optimal evaluation of side effects of treatments and their impact on quality of life. Therefore, the objective of our study was to analyze the functional outcomes at different timepoints for urinary continence and erectile function in patients treated with active surveillance (AS), brachytherapy (BT), radiotherapy (RT, +/- hormonal treatment (HT)) and radical prostatectomy (RP). Methods: Since May 2019, all patients treated for localized prostate cancer in our center have been offered inclusion in a digital prospective program, with automated sending of PROMs questionnaires via a dedicated digital application, before treatment (baseline), at 1 (M1), 3 (M3), 6 (M6) and 12 months (M12). Data were analyzed for urinary continence and erectile function (EPIC-26 HRQOL Domain Summary Score of Urinary Incontinence (UI) and Sexuality) according to treatment strategy. Results: Overall, 552 patients answered questionnaires (05/2019-12/2022), including 97 AS patients, 23 patients treated by BT, 9 patients treated by RT, 37 patients treated by RT with HT and 386 patients treated by RP. Regarding continence, the median UI score at M12 (compared to baseline) was 88 (vs. 100) for AS, 100 (vs. 100) for BT, 100 (vs. 100) for RT, 93 (vs. 100) for RT with HT and 100 (vs. 100) for RP. Regarding erectile function, the median sexuality score at M12 (compared to baseline) was 100 (vs. 73) for AS, 40 (vs. 61) for BT, 40 (vs. 47) for RT, 17 (vs. 54) for RT with HT, 32 (vs. 67) for RP. Conclusions: Surgical treatment transiently affects continence but with almost complete recovery at one year in the majority of cases. However, erectile dysfunction remains a critical issue with an important deterioration for surgery as well as radiotherapy with combined HT. [Table: see text]