abiraterone acetate / Generic mfg. - LARVOL DELTA

The Subject Expert Committee (SEC) on Oncology, under the Central Drugs Standard Control Organisation (CDSCO), has recommended the grant of permission to MSN Laboratories Private Limited for the manufacture and marketing of Abiraterone Acetate Tablets 1000 mg, after reviewing the firm's bioequivalence (BE) report and clinical trial waiver justification. (Medical Dialogues) - "However, the approval was given with the specific condition that the firm shall conduct a Phase IV clinical trial to evaluate the product in the post-marketing setting."

Approval • Castration-Resistant Prostate Cancer

Evaluating Clinical Tools to Monitor Cardiovascular Risk in Men With Prostate Cancer Receiving Hormone Therapy. (PubMed, JCO Oncol Pract) - P2 | "After 6 months of ADT plus ARPI, men with prostate cancer showed worsening lipid profiles and 21% had worsening of their CV risk based on general population tools. These findings highlight the unmet need to develop prostate cancer-specific CV risk assessment tools."

Journal • Atherosclerosis • Cardiovascular • Dyslipidemia • Genito-urinary Cancer • Metabolic Disorders • Oncology • Prostate Cancer • Solid Tumor

Chidamide (a Histone Deacetylase Inhibitor) Plus Abiraterone in Metastatic Castration-Resistant Prostate Cancer (mCRPC): A Phase Ib Trial. (PubMed, MedComm (2020)) - "Our study suggested that chidamide plus abiraterone is well tolerated in mCRPC, and preliminary evidence suggests that it may improve the survival of patients with mCRPC. Furthermore, combining chidamide with immunotherapy could be another promising option for further enhancing its efficacy."

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

The Impact of Early Modification of Upfront Androgen Receptor Signaling Inhibitors on Survival Outcomes in Metastatic Hormone-Sensitive Prostate Cancer. (PubMed, Prostate) - "Early withdrawal of initial upfront ARSI was associated with poor CRPC-FS and PFS2 among mHSPC patients. Maximizing the effectiveness of first-line treatment requires optimal management of ARSI therapy."

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

Prostate-specific Antigen and Objective Response Analyses in PROpel: Olaparib Plus Abiraterone Versus Placebo Plus Abiraterone as First-line Therapy for Metastatic Castration-resistant Prostate Cancer. (PubMed, Eur Urol Oncol) - P3 | "Results for ORR, DoR, confirmed PSA50-RR, and time to PSA progression favoured Ola + Abi over P + Abi in the ITT population and biomarker subgroups. The data support consideration of Ola + Abi as first-line treatment for mCRPC."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • HRD

PSMA uptake in glioblastoma: a diagnostic curveball in neuro-oncology (WFNOS 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

Phase 3 AMPLITUDE trial: Niraparib (NIRA) and abiraterone acetate plus prednisone (AAP) for metastatic castration-sensitive prostate cancer (mCSPC) patients (pts) with alterations in homologous recombination repair (HRR) genes (DGHO 2025) - P3 | "NIRA+AAP significantly improved rPFS and TSP vs AAP and had a favorable effect on OS. There were no new safety signals. AMPLITUDE supports NIRA+AAP as a potential new standard of care for pts with HRR gene–altered mCSPC."

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • BRIP1 • CDK12 • CHEK2 • FANCA • HRD • PALB2 • RAD51B • RAD54L

Real-World Evidence on Prostate Cancer Management in Germany: A Retrospective Analysis of Electronic Health Records to Investigate Clinical Characteristics, Treatment Patterns, and Survival (DGHO 2025) - "Common first-line treatments for metastatic CRPC were abiraterone (40%), docetaxel (38%), and enzalutamide (18%). This real-world analysis provides a detailed view of PC care in Germany, highlighting clinically meaningful variations in disease presentation, biomarker testing, and treatment pathways. These insights can inform practice, identify gaps in testing or therapy use, and generate hypotheses for future research in personalized, biomarker-driven care. Anticipated growth in patient numbers may help validate these initial impressions."

HEOR • Real-world • Real-world evidence • Retrospective data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA

Low Dose Naltrexone (LDN) for Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT) (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: University of Arkansas

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

Androgen Reduction in Congenital Adrenal Hyperplasia, Phase 1 (clinicaltrials.gov) - P1 | N=4 | Terminated | Sponsor: University of Texas Southwestern Medical Center | N=36 ➔ 4 | Suspended ➔ Terminated; The study has been affected significantly by the COVID pandemic, drug supply/drug amendment, low recruitment interest, and FDA approval of another drug with the same indication, so this study has not met its primary endpoint data requirements.

Enrollment change • Trial termination • Congenital Adrenal Hyperplasia • Endocrine Disorders

Interim Analyses of AMPLITUDE (Patients with Metastatic Castration-Sensitive Prostate Cancer with Homologous Recombination Repair Gene Alterations): The Importance of Genomic Testing (AMP 2025) - P3 | "In MAGNITUDE, niraparib (NIRA; a selective, potent PARP1/2 inhibitor) combined with abiraterone acetate + prednisone (AAP) significantly improved radiographic progression-free survival (rPFS) in pts with HRR+ mCRPC (HR = 0.76 [95% CI: 0.60 to 0.97], p = 0.0280)...Pts with ≤6 months androgen deprivation therapy ± ≤6 cycles docetaxel ± ≤45 days AAP were randomized 1:1 to dual-action tablet (NIRA 200mg + AA 1,000mg) + 5mg prednisone, or PBO + AAP... NIRA + AAP significantly improved rPFS and TSP versus AAP, had favorable OS benefit and safety consistent with prior experience. AMPLITUDE supports early genomic testing in pts with mPC, reinforcing guideline recommendations and the need for efficient testing pathways in clinical practice."

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • BRIP1 • CDK12 • CHEK2 • FANCA • HRD • PALB2 • RAD51B • RAD54L

Chromosomal instability in circulating tumor cells and cabazitaxel resistance in metastatic castration-resistant prostate cancer. (PubMed, JCI Insight) - P4 | "This preplanned biomarker analysis of CARD confirms that CTC-CIN counts are a clinically useful prognostic and predictive biomarker of taxane resistance in mCRPC. Detectable CTC-CIN at baseline defines a patient subpopulation with unmet clinical needs in which alternative therapeutics should be tested."

Circulating tumor cells • Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CTCs

The Germline HSD3B1 Variant Is Associated With Response to Androgen Deprivation Therapy and Abiraterone but not With Response to Enzalutamide in Chinese Prostate Cancer Patients. (PubMed, Prostate) - "The HSD3B1 germline variant (1245C) is linked to earlier ADT failure and diminished efficacy of abiraterone but does not affect enzalutamide in the treatment of PCa patients. These findings underscore its potential as a biomarker to guide personalized treatment in PCa."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • HSD3B1

Abiraterone vs Enzalutamide Among US Veterans With Metastatic Hormone-Sensitive Prostate Cancer. (PubMed, JAMA Netw Open) - "This cohort study found that abiraterone and enzalutamide had comparable outcomes in a first-line mHSPC setting, with similar g-rates and OS in both White and African American patients. There were no differences in survival or g-rate between treatment based on race, comorbidities, and prostate cancer features, including Gleason score, PSA, and volume of disease."

Clinical • Journal • Cardiovascular • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Impact of statins on metastatic castration-resistant prostate cancer patients receiving new hormonal agents. (PubMed, Arch Ital Urol Androl) - "Our study suggests a prognostic impact of statin use in the PFS in patients receiving abiraterone or enzalutamide for mCRPC. This may be related to the enhancement of the antitumor activity of the ADT drugs, but also to the cardioprotective effects associated with statin use."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • SLCO2B1

PSMAfore: 177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer (clinicaltrials.gov) - P3 | N=469 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Sep 2025 ➔ Sep 2026

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

French recommendations from the AFU Cancer Committee for prostate cancer 2025 Summary of changes. (PubMed, Fr J Urol) - "This 2025 summary of changes of French recommendations on PCa should help physicians to stay up-to-date with recent evolutions and aim to improve the management of PCa patients."

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

TRIPLE-SWITCH(SWOG/CCTG-PR26): Randomized Phase III Clinical Trial of Docetaxel with Androgen Receptor Pathway Inhibitors for Metastatic Castration-Sensitive Prostate Cancer Patients with a Suboptimal PSA Response (PCF 2025) - P3 | "Participants are randomized to one of two arms: ▪ Arm 1: Patients will continue on standard ADT + ARPI (abiraterone acetate with prednisone, apalutamide, enzalutamide, or darolutamide). SPL: Aura Bioscience, FKD, JBL (SWOG), Genentech (SWOG), Merck (Alliance), QED Therapeutics, Surge Therapeutics, Vaxiion, Viventia. Consultant/Advisory Board:Aura Bioscience, BMS, C2iGenomics, Ferring, Immunity Bio, Incyte, Gilead, Pfizer/EMD Serono, Protara, Surge Therapeutics, Tyra Biosciences, UroGen, Vaxiion, Verity; Patent – TCGA classifier; Honoraria – Grand Rounds Urology, UroToday"

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Induction of apoptosis and growth inhibition by silodosin and abiraterone acetate in PC-3 human prostate cancer cells. (PubMed, Investig Clin Urol) - "Silodosin exhibits potent effects in reducing cell viability and promoting apoptosis in androgen-insensitive prostate cancer cells, comparable to AA. When combined, both agents demonstrate synergistic effects with reduced dosing requirements. These findings support further investigation of silodosin as a potential therapeutic in mCRPC."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ANXA5

Comparative effectiveness of androgen receptor pathway inhibitor treatment intensification for metastatic hormone-sensitive prostate cancer in real-world patients. (PubMed, Investig Clin Urol) - "Abiraterone acetate, apalutamide, and enzalutamide showed comparable PFS to mCRPC outcomes, while significant differences in early PSA kinetics were observed, with early PSA response serving as a crucial prognostic factor in mHSPC patients."

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

Abemaciclib plus abiraterone in patients with metastatic castration-resistant prostate cancer (CYCLONE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. (PubMed, Lancet Oncol) - P2/3 | "Dual inhibition of CDK4 and CDK6 and the androgen receptor pathway with abemaciclib plus abiraterone did not improve radiographic progression-free survival compared with abiraterone alone in the CYCLONE 2 study population with mCRPC. Safety of the combination was consistent with the previously reported safety of the individual drugs. Additional research is required to identify effective combination therapies for patients with mCRPC, especially in those presenting with adverse prognostic characteristics."

Clinical • Journal • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hematological Disorders • Hormone Sensitive Prostate Cancer • Interstitial Lung Disease • Neutropenia • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor • AR • CDK6

Testosterone suppression and recovery with abiraterone/prednisone monotherapy after early discontinuation of LHRH-A in hormone sensitive prostate cancer. (PubMed, Prostate Cancer Prostatic Dis) - "Early LHRH-A discontinuation 12 months or more prior to stopping AAP is associated with faster and more frequent T recovery compared to LHRH-A discontinuation within 3 months of AAP cessation, with T levels remaining appropriately suppressed during abiraterone monotherapy."

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

The Continued Relevance of the Seed and Soil Hypothesis to Metastatic tumor Dissemination, Distribution, and Therapy Resistance with an Emphasis on Liver Metastasis in Castration-Resistant Prostate Cancer (PCF 2025) - "Background : Patients with liver metastasis have a poor prognosis and liver metastasis have been associated with the emergence of neuroendocrine prostate cancer post androgen receptor (AR) pathway inhibitors (ARPIs), such as enzalutamide and abiraterone. There are distinct metastatic molecular phenotypes that grow in distinct organ sites. Prevalence of liver metastasis at death is significantly higher than documented in premortem scans and clinical trials. Loss of AR expression in response to ARPIs is confined to patients with liver metastasis, signifying a marker for the AR negative phenotype and predicted for lower response to AR-targeted agents."

Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CK19 • KRT19

Association between medication burden and acute care use in older metastatic prostate cancer patients on androgen receptor signaling inhibitors. (PubMed, Cancer) - "Medication burden, as characterized by suboptimal adherence and polypharmacy, is an independent risk factor for acute care use among older adults initiating ARSI treatment for metastatic prostate cancer. These findings highlight an opportunity for potential interventions to reduce downstream acute care use."

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

A Pain in the Rectum — But Not From the Colon (ACG 2025) - "He later developed osseous metastases and was transitioned to enzalutamide after abiraterone intolerance. His history was further complicated by pulmonary embolism and bilateral deep vein thromboses, managed with rivaroxaban...Immunohistochemistry is essential for accurate diagnosis and appropriate management. This case also highlights the value of multidisciplinary collaboration between gastroenterology, oncology, and pathology in complex diagnostic scenarios."

Colorectal Cancer • Fatigue • Gastroenterology • Gastrointestinal Disorder • Immunology • Pain • Prostate Adenocarcinoma • Prostate Cancer • Pulmonary Disease • Pulmonary Embolism • Respiratory Diseases • Solid Tumor • NKX3-1