abiraterone acetate / Generic mfg. - LARVOL DELTA

APRE: Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity and Other Factors in Metastatic Hormone Naive Prostate Cancer (clinicaltrials.gov) - P2 | N=130 | Recruiting | Sponsor: Martha Mims | Trial completion date: Apr 2034 ➔ Apr 2038 | Trial primary completion date: Nov 2025 ➔ Nov 2028

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Niraparib (NIRA) and abiraterone acetate plus prednisone (AAP) in Chinese patients with breast cancer susceptibility gene (BRCA) altered metastatic castration-sensitive prostate cancer (mCSPC): Subgroup analysis of the phase III AMPLITUDE trial (ESMO Asia 2025) - P3 | "The Chinese BRCA-positive subgroup are consistent with those reported in the overall population of the AMPLITUDE trial, supporting the utility of early genomic testing and the incorporation of NIRA+AAP as a targeted therapeutic approach for Chinese patients with BRCA gene-altered mCSPC."

Clinical • Metastases • P3 data • Breast Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA • BRCA1 • BRCA2 • HRD

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

Radiotherapy combined with fluzopanib and abiraterone acetate tablets (II) treatment for mCRPC (ESMO Asia 2025) - P2 | "This study aims to explore the potential efficacy and safety of the combination of fluzoparib (PARPi), abiraterone acetate (II), and radiotherapy as first-line treatment for patients with mCRPC. This multicenter, open-label, single-arm, phase II clinical study conducted in China included 40 previously untreated mCRPC (metastatic castration-resistant prostate cancer) patients aged ≥18 years. This study is currently in active enrollment stage."

Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer

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

Capivasertib (capi) + abiraterone (abi) vs placebo (pbo) + abi in patients (pts) with PTEN deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC): Phase III CAPItello-281 Chinese subgroup analysis (ESMO Asia 2025) - P3 | "rPFS and OS benefits with capi + abi vs pbo + abi were numerically greater in the Chinese subgroup vs the global population of CAPItello-281. The safety profile was also consistent with the global population and the known profiles of capi and abi. These results support the potential use of capi + abi in pts with PTEN deficient mHSPC from China mainland, Taiwan, and Hong Kong."

Clinical • Metastases • P3 data • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • PTEN

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

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

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

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

Real World Hospitalizations in US Veterans Treated for Metastatic Prostate Cancer with Combination Therapy. (PubMed, Clin Genitourin Cancer) - "Overall, in the real-world setting, the 2 therapy regimens have distinct hospitalization risks and AEs. Patients with respiratory and gastrointestinal comorbidities may be at higher risk when receiving treatment with docetaxel. Alternatively, older and frailer patients who are susceptible to infections and metabolic complications may be at increased risk with ARPIs. These findings may aid physicians in determining the optimal, individualized therapy to mitigate adverse outcomes in patients with mHSPC."

Journal • Real-world evidence • Acute Kidney Injury • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Infectious Disease • Oncology • Prostate Cancer • Renal Disease • Solid Tumor

CONVERT-HB1: Radical Prostatectomy After Systemic Therapy for High-volume Metastatic Hormone-sensitive Prostate Cancer (clinicaltrials.gov) - P2 | N=112 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

A Study of SHR3680, HS-20093 and SHR2554 in Subjects With Prostate Cancer (clinicaltrials.gov) - P2 | N=218 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Cabozantinib and Abiraterone With Checkpoint Inhibitor Immunotherapy in Metastatic Hormone Sensitive Prostate Cancer (CABIOS Trial) (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Washington University School of Medicine | Active, not recruiting ➔ Completed

Checkpoint inhibition • Trial completion • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Two Cases of Metastatic Castration-Resistant Prostate Cancer With Long-Term Survival Treated With Abiraterone. (PubMed, Clin Case Rep) - "We report two cases of metastatic castration-resistant prostate cancer (mCRPC) with long-term survival following treatment with abiraterone. Despite the generally temporary efficacy of abiraterone, both patients remained progression-free for over 5 years, suggesting that some mCRPC patients may achieve durable responses with abiraterone."

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

Bisphenol A disrupts cartilage homeostasis through CYP2C19. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "At the same time, AutoDock Vina evaluated the binding affinities of three compounds (BPA, the OA treatment drug abiraterone retrieved from DrugBank, and the OA modeling agent iodoacetic acid) with core targets...This study provides a new theoretical framework for understanding the mechanism of action of BPA in OA, emphasizing the role of network toxicology in exacerbating OA. These findings may inform future research on the risk of exposure to DEP and provide important insights for public health policy and the development of targeted therapeutic strategies."

Journal • Immunology • Inflammation • Osteoarthritis • Pain • Rheumatology • COL1A1 • CYP2C19 • ITGB1 • PACERR • PTGS2 • TP53

Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer (clinicaltrials.gov) - P1 | N=17 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Oct 2025 ➔ Sep 2026

Trial completion date • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Abiraterone Acetate Triggers ER Stress-Mediated Androgen Receptor Suppression via PERK/ATF4/CHOP Signaling in Prostate Cancer. (PubMed, Int J Urol) - "AA induces ER stress, leading to transcriptional downregulation of the AR and suppression of PCa cell viability and proliferation. Targeting the PERK pathway may enhance AA efficacy in AR-driven PCa."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR • ATF4 • CASP3 • CASP7

Steroidal Scaffolds as Anticancer Agents: Evolution, FDA Approvals, Synthetic Derivatives, SAR Profiles, and Translational Perspectives. (PubMed, Chem Biodivers) - "This manuscript comprehensively explores the development, FDA-approved drugs such as dexamethasone, prednisone, and abiraterone acetate, synthetic innovations, and clinical potential of steroidal derivatives in anticancer therapy. Furthermore, several investigational steroid-drug combinations are currently being evaluated in clinical trials for advanced-stage cancers, including prostate, breast, and head and neck malignancies, underscoring their translational potential. This review highlights both the therapeutic promise and future directions of steroidal anticancer agent, reinforcing their value as a cornerstone in the development of targeted and supportive cancer therapy."

FDA event • Journal • Review • Head and Neck Cancer • Hematological Disorders • Oncology • Solid Tumor

PSMA uptake in glioblastoma: a diagnostic curveball in neuro-oncology (SNO 2025) - "In 2019, he developed nodal recurrence in retroperitoneal and bilateral iliac chain nodes, treated with lymphadenopathy, six cycles of Taxotere-based chemotherapy, and consolidative proton beam radiation (56.25 Gy/25 fractions)...PSA was undetectable on abiraterone/prednisone and leuprolide...He received standard-of-care treatment with radiation, temozolomide, and TTF device... This case illustrates the potential role of PSMA as a diagnostic tool, as it allows for easy identification of glioblastoma neovasculature, as demonstrated in our case report."

Brain Cancer • Genito-urinary Cancer • Glioblastoma • Glioma • High Grade Glioma • Prostate Cancer • Solid Tumor • FOLH1 • MGMT

Global inequities in the access to systemic prostate cancer therapies: A comprehensive global analysis and implications (EMUC 2025) - "While HICs reported near-universal access to most approved agents, access rates declined sharply in UMICs and LICs, especially for newer agents such as abiraterone, enzalutamide, apalutamide, and olaparib. Conclusions Persistent global inequities in access to and affordability of approved systemic therapies for prostate cancer remain, especially in LICs and specific regions. Addressing these disparities requires urgent, coordinated policy action and innovative financing to ensure equitable access to life-saving therapies for all patients."

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

Patient-reported Outcomes for Men with Metastatic Castration-resistant Prostate Cancer Who Received Olaparib plus Abiraterone Versus Placebo plus Abiraterone in the Phase 3 PROpel Study. (PubMed, Eur Urol Oncol) - P3 | "In PROpel, there were no differences in HRQoL or pain scores reported by patients with mCRPC receiving olaparib + abiraterone versus placebo + abiraterone, suggesting that patients can derive a clinical benefit from olaparib + abiraterone while maintaining similar HRQoL in comparison with current standard-of-care treatment. The PROpel trial is registered on ClinicalTrials.gov as NCT03732820."

Journal • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Pain • Prostate Cancer • Solid Tumor • HRD

Real-world treatment patterns in men with metastatic castration resistant prostate cancer (mCRPC) in Europe and Asia between 2020 and 2024 (EMUC 2025) - "Introduction & Objectives Many therapeutic options, including androgen receptor pathway inhibitors (ARPI) with or without docetaxel (DOC), initially approved for use in mCRPC, have now received indications for hormone sensitive prostate cancer...Abiraterone and enzalutamide were the most common ARPIs with relatively identical distribution in 1L mCRPC (except Spain, UK and China )...Radiopharmaceuticals (except the UK) and olaparib (except Italy) use was low (<10%) and limited to later lines (3L+)...Conclusions Despite the availability of newer classes of agents for mCRPC and earlier indication of mCRPC therapies, ARPI remained the most frequent 1L and 2L mCRPC treatment with back-to-back ARPI was still frequent (except the UK) from 2020 to 2024. Findings highlight the need for treatment beyond ARPI to potentially improve the clinical outcomes in men with mCRPC."

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