Xtandi (enzalutamide) / Pfizer, Astellas, Royalty - LARVOL DELTA

Impact of Metastatic Hormone-sensitive Prostate Cancer Treatments on Health-related Quality of Life: A Systematic Review and Network Meta-analysis. (PubMed, Eur Urol Focus) - "HRQoL outcomes differ across treatment strategies for mHSPC. At 12 mo, ADT + abiraterone yielded the most favourable HRQoL profile."

HEOR • Journal • Retrospective data • Review • Fatigue • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Pain • Prostate Cancer • Solid Tumor

A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=72 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P1/2 trial • Oncology • Prostate Cancer • Solid Tumor

Drug utilisation evaluation of oral anticancer therapy in a south indian cancer centre (ESMO Asia 2025) - "Among targeted therapies, Gefitinib, Osimertinib, Crizotinib, Afatinib, Lorlatinib, and Nilotinib demonstrated consumption of 30 DDDs per patient over 30 days. Lower consumptions were observed with Lenvatinib and Cabozantinib with 13.3 DDDs and 11.25 DDDs per patient respectively. In the hormonal therapy group, Letrozole, Tamoxifen, Bicalutamide, Anastrozole, Enzalutamide, and Exemestane were all prescribed in line with WHO standards (30 DDDs per patient), whereas Abiraterone exhibited lower consumption of 15 DDDs per patient. Prescribing patterns and consumption metrics were largely consistent with WHO criteria, indicating rational oral anticancer drug use. Prescribing patterns and consumption metrics were largely consistent with WHO criteria, indicating rational oral anticancer drug use. Dose deviations occurred, though reasons were unclear and may relate to adverse effects, indication-specific or patient factors, or economic constraints. Further research is warranted..."

Oncology • Oral Cancer

Synergy between enzalutamide and selective Bcl-2 family inhibitors in metastatic castration-resistant prostate cancer (ESMO Asia 2025) - "While venetoclax (Bcl-2 inhibitor) combinations with enzalutamide have entered clinical evaluation, the relative benefit of inhibiting different Bcl-2 family members under identical experimental conditions has not been directly compared. DU145 mCRPC cells were treated for 48 h with enzalutamide (ENZA) alone or in combination with ABT-199 (Bcl-2 inhibitor), A-1331852 (Bcl-xL inhibitor), or AZD5991 (Mcl-1 inhibitor). In a direct comparison under uniform conditions, Mcl-1 inhibition with AZD5991 emerged as the most effective partner for ENZA in DU145 cells, followed by Bcl-xL inhibition, while Bcl-2 inhibition was less impactful. These findings support further evaluation of Mcl-1-targeting strategies as a means to overcome AR-independent resistance in mCRPC, while underscoring the need for cautious interpretation of large in-vitro dose-reduction estimates."

IO biomarker • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ANXA5 • BCL2L1

First-line enzalutamide vs abiraterone for castration-resistant prostate cancer: A real-world study in Japan (ESMO Asia 2025) - "This real-world analysis suggests that while ENZ was associated with longer OS in the unmatched population, there was no significant difference in OS between ENZ and ABI after adjusting for key clinical characteristics."

Clinical • Real-world • Real-world evidence • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Treatment intensification in metastatic hormone sensitive prostate cancer (mHSPC), real-world adoption of combination therapies in Australia and Asia (ESMO Asia 2025) - "Background: The addition of androgen receptor pathway inhibitors (ARPI) with or without docetaxel (DOC) to androgen deprivation therapy (ADT) has significantly improved outcomes in mHSPC...In Asia, the most common ARPI was apalutamide (41%) and abiraterone (41%). In Australia, darolutamide (30%) and enzalutamide (30%) were most used... Our real-world data demonstrates improved adoption of standard of care therapy since January 2023 in Australia and Asia. The use of ADT alone may reflect differences in the real-world population. However, the improvement seen in time to CRPC with combination therapy demonstrates the survival gains that can be achieved in the real-world setting."

Clinical • Combination therapy • Metastases • Real-world • Real-world evidence • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Glutathione-responsive folic acid modified fluorescent SBA-15 nanocarrier for simultaneous imaging and drug delivery in prostate cancer treatment. (PubMed, J Mater Sci Mater Med) - "The enzalutamide (ENZ, anticancer drug) and folic acid (FA, targeting agent) were covalently conjugated to SBA-15 and the resulted FA-SBA-15/ENZ was loaded with thiolated nitrogen-doped carbon dots (SNCDs) as a fluorescent label for imaging...In addition, the toxicity of the synthesized nanocarriers with a certain amount of drug was evaluated using an MTT assay. The developed FA-SNCD@SBA-15/ENZ multifunctional nanocarrier showed higher cytotoxicity compared with the untreated drug and nanoparticles in the PC3 human prostate cancer cell line."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Therapeutic Advances in Metastatic Prostate Cancer: A Journey from Standard of Care to New Emerging Treatment. (PubMed, Int J Mol Sci) - "We detail the evidence supporting the integration of systemic agents like abiraterone, enzalutamide, and darolutamide into both hormone-sensitive and castration-resistant settings. Furthermore, we highlight the expanding role of radioligand therapies, including radium-223 and Lutetium-177-labeled PSMA-617 (Lu-PSMA-617), as well as the growing impact of PARP inhibitors in genomically selected patients. The emergence of theranostic strategies and next-generation sequencing has paved the way for personalized treatment algorithms, moving toward a truly precision oncology model in PCa. This comprehensive review synthesizes current therapeutic strategies, clinical trial evidence, and future directions aimed at optimizing outcomes and quality of life for patients with advanced prostate cancer."

Journal • Review • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • PTEN • TP53

PETRANHA: Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer (clinicaltrials.gov) - P1/2 | N=174 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Tumor Microenvironmental NRG1 Drives Resistance to PI3K Pathway Inhibition in Prostate Cancer (SUO 2025) - "Cells were treated with PI3K pathway inhibitors (GDC-0941, Capivasertib, Sapanisertib) alone and in combination with enzalutamide, an androgen receptor inhibitor...In 22RV1 cell line xenografts, combination therapy with seribantumab, enzalutamide, and pictilisib significantly suppressed tumor growth compared to enzalutamide and pictilisib alone ( Figure 1D )... The TME-derived secretome plays a critical role in modulating resistance to targeted therapies in prostate cancer. NRG1 in the PCa TME, activates HER3 signaling and promotes resistance to both AR and PI3K pathway inhibitors. Targeting HER3 in combination with PI3K inhibitors represents a promising therapeutic strategy to overcome NRG1-mediated resistance mechanisms in advanced prostate cancer."

Biomarker • Tumor microenvironment • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • NRG1

CircPPFIA2 drives prostate cancer progression and enzalutamide resistance by sponging miR-646 and miR-1200 to upregulate ETS1. (PubMed, Cell Death Discov) - "To functionally validate this finding, we employed lipid nanoparticle (LNP)-mediated co-delivery of si-circPPFIA2 and enzalutamide, which effectively restored drug sensitivity and inhibited tumor growth in resistant PCa models. Our findings highlight circPPFIA2 as both a prognostic biomarker and a promising therapeutic target for advanced PCa, providing a rationale for developing circRNA-directed therapies to overcome treatment resistance."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ETS1 • MIR1200

Phase Ib study of enzalutamide with venetoclax in patients with metastatic castration-resistant prostate cancer. (PubMed, Cancer Chemother Pharmacol) - P1 | "Enzalutamide with venetoclax has an acceptable toxicity profile in patients with mCRPC. Despite sub-optimal venetoclax levels, the treatment elicited pharmacodynamic and clinical response in a subset of patients."

IO biomarker • Journal • P1 data • Castration-Resistant Prostate Cancer • Fatigue • Genito-urinary Cancer • Hematological Disorders • Oncology • Prostate Cancer • Solid Tumor • Thrombocytopenia

Consideration of Off-Label Therapies as Appropriate Comparator Therapy in Early Benefit Assessments in Germany Under the ALBVVG Legislation (ISPOR-EU 2025) - "The G-BA decisions regarding the choice of ACT were analyzed with a focus on the reasoning provided in the supporting documents. The selected EBA procedures showed varying outcomes: For dupilumab (eosinophilic esophagitis), an established off-label therapy was considered appropriate based on evidence-based guidelines and extensive clinical experience. For midostaurin (systemic mastocytosis), avapritinib, cladribine, and imatinib were recognized as ACT despite not all being approved for the corresponding indication, acknowledging their established role in treatment algorithms. For lisocabtagene maraleucel (various B-cell lymphomas after prior therapy), off-label use was deemed appropriate, particularly considering the disease severity and limited therapeutic alternatives for these vulnerable patients. Conversely, for talazoparib (metastatic castration-resistant prostate carcinoma), the off-label use of abiraterone acetate with prednisone/prednisolone and enzalutamide was..."

B Cell Lymphoma • Castration-Resistant Prostate Cancer • Eosinophilic Esophagitis • Gastrointestinal Disorder • Genito-urinary Cancer • Hematological Malignancies • Immunology • Lymphoma • Non-Hodgkin’s Lymphoma • Prostate Cancer • Solid Tumor

A Study to Learn About Two Medicines (Apalutamide and Enzalutamide) in People With Metastatic Castration-sensitive Prostate Cancer (mCSPC) (clinicaltrials.gov) - P=N/A | N=1300 | Completed | Sponsor: Pfizer | Recruiting ➔ Completed

Real-world evidence • Trial completion • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Preclinical Efficacy of TSL2109 in Prostate Cancer Treatment and Overcoming Enzalutamide Resistance. (PubMed, J Med Chem) - "Collectively, these results indicate that TSL2109 is a highly promising anticancer agent with the potential to overcome therapy resistance, thereby addressing an unmet clinical need. Supported by these findings, TSL2109 has been approved for clinical trials in China."

Journal • Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

IGFBP3-SphK1/S1P Signaling Axis Drives Enzalutamide Resistance in Advanced Prostate Cancer. (PubMed, Mol Cancer Ther) - "Similarly, targeting SphK1 with the inhibitor SKI-II suppressed SphK1 activity, reduced S1P production, enhanced enzalutamide sensitivity, and significantly inhibited resistant tumor growth while enhancing enzalutamide sensitivity. Collectively, these findings highlight IGFBP3-mediated SphK1 signaling as a critical mediator of enzalutamide resistance and suggest that targeting the IGFBP3/SphK1/S1P axis represents a promising therapeutic strategy to overcome resistance in advanced prostate cancer."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • IGFBP3 • SPHK1

Enzalutamide Monotherapy for the Treatment of Prostate Cancer With High-Risk Biochemical Recurrence: EMBARK Secondary Endpoints. (PubMed, J Urol) - P3 | "Secondary endpoint results support enzalutamide monotherapy as a potential option to improve efficacy and preserve sexual health vs leuprolide alone for patients with high-risk biochemical recurrence. NCT02319837."

Journal • Monotherapy • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Treatment of High-Risk Biochemically Recurrent Prostate Cancer With Enzalutamide in Combination With Leuprolide: Secondary Endpoints From the EMBARK Trial. (PubMed, J Urol) - P3 | "Combined with the primary findings from EMBARK, data from non-key secondary efficacy endpoints strengthen support for enzalutamide combination as a new standard of care for patients with high-risk BCR. NCT02319837."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Tbcrc 058: a randomized phase 2 study of enzalutamide, enzalutamide with mifepristone, and treatment of physician's choice in patients with androgen receptor-positive metastatic triple-negative or estrogen receptor-low breast cancer (nct06099769) (SABCS 2025) - P2 | " This is a randomized phase II trial; 201 patients (pts) will be randomized in a 1:1:1 fashion to enza, enza plus mif, or TPC (carboplatin, paclitaxel, eribulin, or capecitabine). As of 7/9/2025, 19 of 201 pts have begun protocol-specified tx. This trial is supported by the Translational Breast Cancer Research Consortium, The Breast Cancer Research Foundation, The TaTa Sisterhood Foundation, Pfizer/Astellas, and Corcept Therapeutics."

Clinical • IO biomarker • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • AR • CTCs • ER • HER-2 • PGR

Association of SULT2A1 Locus With Abiraterone Clearance in the Alliance A031201: Randomized Phase III Study of Enzalutamide Compared With Enzalutamide Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer. (PubMed, Clin Transl Sci) - P3 | "Genetic variation in SULT2A1 may be useful to inform personalized dosing of abiraterone. ClinicalTrials.gov Identifier: NCT01949337."

Clinical • Journal • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CYP2C19 • CYP3A4 • CYP3A5 • SLCO2B1 • UGT1A4

Apa/Enza-short Study: Shorter Treatment With Androgen Receptor Pathway Inhibitor in Patients With Low-volume Metastatic Castration-sensitive Prostate Cancer (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: Nick Beije

New P3 trial • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Efficacy at a cost?-quality of life implications of PARP inhibition in the homologus recombination repair (HRR) cohort of TALAPRO-2. (PubMed, Transl Androl Urol) - No abstract available

HEOR • Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Casticin inhibits AKR1C3 and enhances abiraterone efficacy in castration-resistant prostate cancer. (PubMed, J Nat Med) - "CAS significantly enhanced ABI's cytotoxic efficacy in 22Rv1 cells, as evidenced by synergistic interactions (CI: 0.31-0.71); however, no such synergy was observed in LNCaP cells or with enzalutamide. Docking and molecular dynamics simulations indicated a stable CAS-AKR1C3 interaction, characterized by crucial hydrogen bonding and aromatic stacking within the active site. These results suggest that CAS is a promising chemosensitizer targeting AKR1C3 to overcome ABI resistance in CRPC."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AKR1C3

Apalutamide is linked to fewer CNS-related conditions in patients with nmCRPC (Urology Times) - "...Research presented at the 2025 Society of Urology Oncology Annual Meeting....The investigators reported that new onset of CNS-related conditions was lower in patients in the apalutamide cohort at 12 months (apalutamide, 25.7%, darolutamide, 31.4%, enzalutamide, 40.8%) and 24 months (apalutamide: 46.6%, darolutamide: 54.6%, enzalutamide: 59.7%) post index. The median time-to-new onset of CNS-related conditions was 29.2 months in the apalutamide cohort vs 21.3 months in the darolutamide cohort and 18.1 months in the enzalutamide cohort."

Retrospective data • Castration-Resistant Prostate Cancer

Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (clinicaltrials.gov) - P2 | N=25 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2027 ➔ Nov 2028 | Trial primary completion date: Jan 2027 ➔ Nov 2028

Enrollment closed • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor