abiraterone acetate / Generic mfg. - LARVOL DELTA

Solid Supersaturated Self-Nanoemulsifying Drug Delivery System for Abiraterone Acetate: Improved Drug loading, Dissolution, Cellular Uptake and Anticancer Activity. (PubMed, Pharm Dev Technol) - "In-vitro cell culture studies in the PC-3 cell line denoted significantly enhanced anticancer activity and cellular uptake. Thus, ABT-ssSNEDDS could be an encouraging approach for improved oral therapy and enhanced drug loading of ABT."

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

NCI-2018-02551: Sacituzumab Govitecan in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy (clinicaltrials.gov) - P2 | N=31 | Active, not recruiting | Sponsor: University of Wisconsin, Madison | Trial completion date: Apr 2025 ➔ Sep 2027

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

Real-world outcomes among patients with metastatic castration-resistant prostate cancer (mCRPC) receiving guideline-recommended therapies after treatment with 177Lu-PSMA-617: A real-world prostate cancer disease observation (PRECISION) data platform analysis. (ASCO-GU 2025) - "Guideline-recommended therapies included abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel, pembrolizumab, sipuleucel-T, niraparib, olaparib, talazoparib, rucaparib, and radium-223. In this real-world analysis, the majority of patients who received guideline-recommended therapies after 177Lu-PSMA-617 achieved at least a PSA50 response, suggesting that 177Lu-PSMA-617 treatment does not preclude response to other subsequent therapies."

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

Systemic Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer: ASCO Guideline Update. (PubMed, J Clin Oncol) - "Prior systemic therapy for castration-sensitive prostate cancer will determine subsequent therapy used for mCRPC. Continue androgen-deprivation therapy for patients with mCRPC indefinitely. Early adoption of somatic genetic testing and palliative care is recommended. Patients with mCRPC and bony metastases should receive a bone-protective agent. The panel recommends the combination of ARPI with PARPi in patients with BRCA1/2 alterations who did not receive prior ARPI. For patients who received prior ARPI, the panel recommends docetaxel chemotherapy. The panel recommends 177Lu-PSMA-617 or cabazitaxel chemotherapy for patients who receive prior ARPI and docetaxel chemotherapy. For patients with BRCA1/2 alterations who received prior ARPI, the panel recommends PARPi monotherapy. Radium 223 is recommended for patients with symptomatic bone-only disease. Evidence for optimal sequencing for mCRPC regimens is lacking.Additional information is available at..."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Microsatellite Instability • Oncology • Palliative care • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • MSI

Niraparib and Abiraterone Acetate plus Prednisone in Metastatic Castration-resistant Prostate Cancer: Final Overall Survival Analysis for the Phase 3 MAGNITUDE Trial. (PubMed, Eur Urol Oncol) - "The MAGNITUDE final analysis showed that patients with HRR+ mCRPC, including those with the approved indication of BRCA-altered mCRPC, generally continue to benefit from first-line treatment with niraparib + AAP in comparison to placebo + AAP."

Journal • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hematological Disorders • Oncology • Prostate Cancer • Solid Tumor • BRCA • BRCA1 • BRCA2 • HRD

Systemic treatment options for metastatic castration resistant prostate cancer: A living systematic review. (PubMed, medRxiv) - "Treatment benefit was observed with abiraterone, enzalutamide, cabazitaxel, docetaxel (if no prior docetaxel), and Lu 177 (if PSMA+) for patients without HRR alterations. https://osf.io/46tjm. NIH U24 grant (U24CA265879-01-1)."

Clinical • Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA • CDK12 • HRD • PALB2

High-throughput screening reveals novel synergistic drug combinations for metastatic castration-resistant prostate cancer (AACR 2025) - "Metastatic castration-resistant prostate cancer (mCRPC) remains a significant clinical challenge, with patients often developing resistance to androgen receptor (AR)-axis-targeted therapies such as Abiraterone and Enzalutamide...These results guided the development of a novel triple combination therapy to simultaneously target CDK9-regulated productive RNA polymerase II phosphorylation (Enitociclib), BRD4-mediated epigenetic remodeling (Pelabresib), and pro-survival BcL-xL (Navitoclax)...These findings provide a strong rationale for clinical development of multi-drug targeted combination regimens to overcome AR-V7-driven resistance and deliver durable responses with reduced toxicity for mCRPC patients with limited treatment options. Our approach also highlights the power of HTS to unbiasedly innovate synergistic therapies while uncovering critical biological mechanisms underlying cancer drug resistance."

Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR • BCL2L1 • BRD4 • CASP3 • CASP7 • CDK9

A Multinational, Multicenter, Prospective, Randomized, Controlled, Open-Label, Phase 3 Study of Lutetium (177Lu) Rosopatamab Tetraxetan in Combination with Standard of Care Versus Standard of Care Alone in Patients with Prostate-Specific Membrane Antigen (SNMMI 2025) - P3 | "In Part 1, patients will be divided into 3 groups (n=10 each) to receive 2 single intravenous (IV) injections of 76 milicuries (mCi) each, 14 days apart, of 177Lu-rosopatamab with best standard of care (SoC) combinations with abiraterone, enzalutamide, or docetaxel to fully characterize biodistribution and safety profiles of 177Lu-DOTA-rosopatamab + SoC combinations...Eligible patients must have PSMA-expressing metastatic castration-resistant PC (mCRPC) that have progressed despite prior therapy with either enzalutamide or abiraterone plus prednisone, and 1 line of prior taxane therapy or have refused or are ineligible for taxanes... Effective treatment options for mCRPC with favorable safety and tolerability profiles continue to be an unmet need. Combining the advantages of targeted radiotherapy and immunotherapy, along with proven patient selection capabilities of 68Ga-PSMA-11 PET, provides reasonable justification for further evaluation of 177Lu-rosopatamab in a..."

Clinical • Combination therapy • P3 data • Cardiovascular • Castration-Resistant Prostate Cancer • Cerebral Hemorrhage • CNS Disorders • Epilepsy • Genito-urinary Cancer • Hematological Disorders • Hepatocellular Cancer • Oncology • Prostate Cancer • Solid Tumor

Eight-year follow-up of patient outcomes and bone health in radium-223-treated patients: data from the global REASSURE study (SNMMI 2025) - P | "Previous treatments included abiraterone (48% of pts), enzalutamide (39%), docetaxel (39%), and cabazitaxel (9%). Overall, 1472 pts treated from 2014 to 2017 across 191 centres in 20 countries were included in this final analysis (median follow-up 17 months; range 0.3–95.4). The median age was 73 years (range 44–94). Most pts had an Eastern Cooperative Oncology Group performance status of 0 or 1 (80%)."

Clinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Musculoskeletal Diseases • Musculoskeletal Pain • Oncology • Pain • Prostate Cancer • Solid Tumor

A randomized, open-label, multi-center, active-controlled phase II study comparing abiraterone acetate tablets (II), an improved formulation, versus originator abiraterone acetate in patients with metastatic castration-resistant prostate cancer. (PubMed, BMC Med) - P2 | "AAT(II) at 300 mg plus prednisone demonstrated equivalent PD as OAA at 1000 mg plus prednisone in reducing serum testosterone on Day 9 and/or Day 10, and the effect was maintained up to the end of the study. Compared to OAA, AAT(II) was given at a much lower dosage and was not affected by food consumption. AAT(II) was well tolerated, and no new safety issues were found."

Journal • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Case Report: Two cases of chemotherapy refractory aggressive variant prostate cancer with extreme durable response to PARP inhibitor. (PubMed, Front Oncol) - "He was treated with docetaxel/albumin-bound paclitaxel and cisplatin in the first line. Second-line therapy was applied with radiotherapy and Olaparib after failure of first-line therapy, resulting in a PSA response sustained for three years...Radiotherapy and Fluzoparib + abiraterone was applied as subsequent treatments with a PSA response for 2 years. These two cases demonstrating a satisfactorily durable response to PARP inhibitors indicating its clinical benefit in AVPC population with detected DNA damage response (DDR) defects. The survival improvement with PARP inhibitors observed in our clinical experiences, along with current advances in tumor sequencing provide more information on future clinical trials and explorations of innovative therapies in AVPC population."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA2 • FANCA • HDAC2 • PTEN • RB1 • TP53

Similar Rates of Second Electron Transfer and Single-Turnover Dehydroepiandrosterone Formation for Oxyferrous Human Cytochrome P450 17A1 (Steroid 17-Hydroxylase/17,20-lyase)-17-hydroxypregnenolone Complex with Either Human Cytochrome P450-Oxidoreductase or Human Cytochrome b5. (PubMed, Biochemistry) - "The 17-hydroxylase and 17,20-lyase activities of cytochrome P450 17A1 are required for androgen biosynthesis, which is the target of the prostate-cancer drug abiraterone acetate...We conclude that rates of electron transfer and product formation for the 17,20-lyase reaction starting with reduced oxyferrous P450 17A1 are similar and partially rate-limiting to either POR or b5. These data suggest that the b5 effect on the 17,20-lyase reaction manifests only during multiple turnover conditions rather than enhancing single-turnover kinetics."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CYB5A • CYP17A1

Overall survival in patients with metastatic castration-sensitive prostate cancer treated with apalutamide versus abiraterone acetate: a head-to-head analysis of real-world patients in the USA. (PubMed, J Comp Eff Res) - "At 24 months post-index, patients in the apalutamide cohort had a 26% lower risk of mortality compared with those in the abiraterone acetate cohort (hazard ratio: 0.74; 95% confidence interval: 0.59, 0.93; p = 0.010), with the difference maintained when outcomes were evaluated using all available follow-up (hazard ratio: 0.72; 95% confidence interval: 0.59, 0.88; nominal p < 0.001). In this nationally representative, real-world head-to-head analysis of nearly 4000 ARPI-naive patients with mCSPC, apalutamide was associated with a 26% reduction in the risk of mortality compared with abiraterone acetate by 24 months post-treatment initiation."

Head-to-Head • Journal • Real-world evidence • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • Urology

A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (clinicaltrials.gov) - P=N/A | N=3017 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

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

Early Access Program in oncology: Retrospective study at a Portuguese hospital (ECOP 2024) - "During the study period were submitted 163 EAP requests for abiraterone, amivantamab, bevacizumab, durvalumab, encorafenib, enfortumab, everolimus, erdafitinib, lenvatinib, lurbinectedin, niraparib, nivolumab, olaparib, pembrolizumab, pertuzumab, ramucirumab, sacituzumab govitecan, selpercatinib, trifluridine/tipiracil, trametinib+dabrafenib, trastuzumab-deruxtecan and tucatinib. Conclusion Most cases correspond to metastatic disease, EAPs facilitate timely access to innovative therapies for patients with high unmet medical needs. The majority of situations were financed, which confirms the importance of EAPs in an era where oncology is constantly innovating."

Retrospective data • Gastrointestinal Disorder • Oncology

ENDOCRINOLOGICAL ADVERSE EFFECTS OF ABIRATERONE ACETATE IN THE TREATMENT OF PROSTATE CANCER: REAL-WORLD PREVALENCE (ESPE-ESE 2025) - "In order to mitigate this risk, treatment regimens include prednisone (5mg/day). AA is an increasingly utilized agent in the management of prostate cancer, with potential EAE— including MES and AI—whose prevalence remains poorly characterized. Our findings contribute to the understanding of these adverse effects in a real-world setting. Recognizing and optimizing the preventive and therapeutic management of AA-associated EAE is essential to improving patient outcomes."

Adverse events • Clinical • Real-world • Real-world evidence • Cardiovascular • Endocrine Disorders • Genito-urinary Cancer • Hypertension • Nephrology • Oncology • Prostate Cancer • Renal Disease • Solid Tumor

Steroidogenesis and CYP17A1 Inhibition: Development of Potent Inhibitors for Adrenal and Gonadal Steroid Biosynthesis (ESPE-ESE 2025) - "Only approved CYP17A1 inhibitor is abiraterone, which has numerous side effects, including inhibition of CYP21A2, and is metabolized into a potent androgen, which renders the treatment futile in long term...The compounds developed in this study offer a potential avenue for therapeutic interventions aimed at regulating steroid hormone production in both adrenal and gonadal contexts. Elevated androgen levels in congenital adrenal hyperplasia can be targeted by these potent inhibitors of CYP17A1 and for treatment of hyperandrogenic conditions like polycystic ovary syndrome."

Congenital Adrenal Hyperplasia • Endocrine Disorders • Polycystic Ovary Syndrome • CYP1A2 • CYP21A2

Predicting the Treatment Effect of Ra-223 Therapy for Metastatic Prostate Cancer Based on Alpha-Particle Range and Pre- Treatment Type (ESTRO 2025) - "Other factors included Gleason Score (GS) and type of prior or concurrent treatment (taxane, abiraterone, enzalutamide)... The efficacy of Ra-223 treatment, as measured by PSA change rate, was found to be significantly associated with prior treatment and GS, regardless of the bone metastasis intensity."

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

A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer (clinicaltrials.gov) - P1 | N=213 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Jun 2025 ➔ Jun 2026

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

PROSTACT GLOBAL: A PHASE 3 STUDY OF 177LU-ROSPTAMAB PLUS STANDARD OF CARE VS. STANDARD OF CARE ALONE IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (AUA 2025) - P3 | "SoC will be determined prior to randomization, and a change in planned SoC will not be permitted.Eligible patients must have PSMA-expressing metastatic castration-resistant PC (mCRPC) that have progressed despite prior therapy with either enzalutamide or abiraterone plus prednisone, and 1 line of prior taxane therapy or have refused or are ineligible for taxanes. An alpha control and 95% confidence intervals will be used; patients will be substratified between TLX591 + 2nd ARPI or TLX591 + docetaxel. This study is currently enrolling."

Clinical • Metastases • P3 data • Cardiovascular • Castration-Resistant Prostate Cancer • Cerebral Hemorrhage • CNS Disorders • Epilepsy • Genito-urinary Cancer • Hematological Disorders • Hepatocellular Cancer • Oncology • Prostate Cancer • Solid Tumor

PSMA PET response vs PSA nadir with ADT & ARPI in oligometastatic hormone sensitive prostate cancer (ESTRO 2025) - "ADT alone was received by 48 patients (51%) while 46 patients (49%) received ADT + ARPI (Abiraterone 41, Enzalutamide 5). In this cohort, higher proportion of patients achieved PSA nadir <0.1ng/ml after treatment with ADT + ARPI vs with ADT alone. However, metabolic response was not different. Exploration of PSMA-PETCT-based response in a larger cohort may help optimize target site selection for MDT."

Metastases • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Clinical outcomes of treatment intensification in metastatic hormone-sensitive prostate cancer: A multidisciplinary single-center experience (ESTRO 2025) - "Systemic treatments included apalutamide (38.2%), enzalutamide (19.6%), abiraterone (11.1%), and docetaxel (8%), with 3.1% ADT monotherapy, and 7.6% receiving triplet therapy with darolutamide or 3.1% with abiraterone. This real-world study from a single center shows the efficacy of ADT combined with NTH in achieving deep PSA responses and improving survival in mHSPC patients. Deep PSA nadir and low-volume disease were identified as a key biomarker for better outcomes. The manageable toxicity profile of NHT supports their application into our clinical practice."

Clinical • Clinical data • Metastases • Cardiovascular • Genito-urinary Cancer • Hematological Disorders • Hormone Sensitive Prostate Cancer • Hypertension • Neutropenia • Oncology • Prostate Cancer • Solid Tumor • Thrombocytopenia • Urology

Real World Treatment Patterns for Castration-Sensitive Prostate Cancer Between 2012 and 2024: A Systematic Review (ISPOR 2025) - "The review focused on ADT usage, including combinations with docetaxel and/or NHTs (abiraterone, apalutamide, enzalutamide, and darolutamide) or with other treatments. This review offers healthcare providers valuable insights into CSPC treatment trends. The findings aim to refine clinical guidelines, inform policymaking, improve resource allocation, and enhance market understanding globally."

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

Plain language summary: how long do patients with metastatic castration-resistant prostate cancer (mCRPC) live when taking abiraterone or enzalutamide in the real world? (PubMed, Future Oncol) - No abstract available

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

Study to Evaluate CCS1477 in Advanced Tumours (clinicaltrials.gov) - P1/2 | N=350 | Active, not recruiting | Sponsor: CellCentric Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Aug 2025 | Trial primary completion date: Dec 2024 ➔ Aug 2025

Enrollment closed • Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • AR • ARID1A • CREBBP • MYC