abiraterone acetate / Generic mfg. - LARVOL DELTA

FDA Approval Summary: Niraparib Plus Abiraterone Acetate Fixed Dose Combination for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer. (PubMed, Clin Cancer Res) - P3 | "On August 11, 2023, the Food and Drug Administration approved the fixed-dose combination (FDC) of niraparib and abiraterone acetate (AA), with prednisone (P), for treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration resistant prostate cancer (mCRPC), as determined by an FDA-approved test. Adding niraparib to AAP resulted in increased toxicity, including anemia requiring transfusion in 27% of patients. This article summarizes the data and the FDA's thought process supporting the traditional approval of niraparib plus AA FDC."

FDA event • Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hematological Disorders • Oncology • Prostate Cancer • Solid Tumor • BRCA • HRD

Adrenal Insufficiency in the Context of Abiraterone Treatment: Clinical Findings and Implications (ENDO 2025) - "Although prednisone 5-10 mg daily is routinely prescribed to prevent mineralocorticoid excess and concomitantly serves as glucocorticoid replacement therapy, adrenal insufficiency as a complication of this treatment may be under-recognized, resulting in underutilization of stress dose steroids during acute illness in this group of patients particularly prone to medical crises. Despite the known effect of abiraterone on cortisol synthesis, fewer than 5% of patients treated with this medication underwent cortisol testing, yet nearly 15% of those tested met criteria for adrenal insufficiency. The true incidence of adrenal insufficiency in this population remains uncertain. However, our findings underscore the importance of maintaining a high clinical suspicion for adrenal insufficiency in patients on abiraterone."

Clinical • Anorexia • Endocrine Disorders • Fatigue • Genito-urinary Cancer • Hypotension • Nephrology • Oncology • Prostate Cancer • Renal Disease • Solid Tumor

What a MES!: A Case of Abiraterone-induced Mineralocorticoid Excess Syndrome (ENDO 2025) - "However, its dual inhibition of 17α-hydroxylase and 17,20-lyase can lead to adverse effects from cortisol suppression.A 79-year-old male with prostate carcinoma and bone metastases on Triptorelin pamoate every six months and abiraterone 250 mg twice daily with prednisone 5 mg once daily for over a year has hypertension with more than three anti-hypertensive medications, including a diuretic, and also has diabetes with chronic kidney disease...Abiraterone was discontinued, and prednisone was switched to dexamethasone due to its lack of mineralocorticoid activity. As amiloride was unavailable, finerenone, a selective mineralocorticoid receptor antagonist, was initiated.Abiraterone inhibits CYP17A1, reducing cortisol production by blocking 17α-hydroxylase and suppressing androgen synthesis, key for prostate cancer progression...Finerenone, a novel, selective MRA, is as effective as spironolactone with fewer side effects and better cardiovascular outcomes, particularly in..."

Clinical • Cardiovascular • Chronic Kidney Disease • Diabetes • Endocrine Disorders • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Hypertension • Metabolic Disorders • Nephrology • Oncology • Prostate Cancer • Renal Disease • Solid Tumor • AR

Role of the gut microbiome in androgen production and prostate cancer treatment resistance (ENDO 2025) - " Metagenomic sequencing showed an imbalance in microbial communities at the phylum level and identified the presence of androgen-synthesizing bacteria such as Clostridium scindens in fecal samples of individuals undergoing treatment with abiraterone acetate/prednisone (AA/P)...Furthermore, we demonstrate that C. scindens converts hydrocortisone and prednisone into the androgen precursor 11β-hydroxyandrost-4-ene-3,17-dione (11OHAD) and ∆1-AT in vitro at 48- and 72h post-treatment... Overall, this study ascertains the ability of the human gut microbiota to harbor androgen-synthesizing bacteria, which in turn can be an alternative source of androgens that could impact prostate cancer treatment responsiveness."

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

Design and Evaluation of novel CYP17A1 Inhibitors: Potential Therapeutic Agents for Castration-Resistant Prostate Cancer (ENDO 2025) - "Although CYP17A1 inhibitors like abiraterone have shown efficacy, drug resistance and adverse effects limit their clinical success...Interestingly, compound 11, despite its potent enzyme inhibition, did not show high cytotoxicity in these cell lines, indicating a selective mechanism of action. Importantly, none of the compounds exhibited significant cytotoxicity in normal prostate cells (RWPE-1), suggesting a favourable therapeutic window.These results show the potential of novel CYP17A1 inhibitors, particularly compound 11, in targeting steroidogenesis and inhibiting CRPC progression."

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

Real-World Treatment Patterns and Survival in People With Metastatic Castration-Resistant Prostate Cancer Following Metastatic Hormone-Sensitive Disease Between 2020 and 2023 in the United States. (PubMed, Clin Genitourin Cancer) - "Back-to-back ARPI use from mHSPC to mCRPC is common in current clinical practice and survival remains <3 years. Alternative mCRPC treatments, such as intensified combination regimens beyond androgen receptor targeting, require exploration to improve survival in mCRPC."

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

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. (BASCO-MN 2025) - No abstract available

Clinical • Late-breaking abstract • Metastases • P3 data • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • HRD

Acute kidney injury in a cancer patient exposed to relugolix and abiraterone. (PubMed, Urol Int) - "We report the first case of biopsy-proven drug-induced AKI in a cancer patient acutely exposed to relugolix and abiraterone. Whether one of these drugs individually, or their combination, was the cause of the AKI is unknown. Nonetheless, our report is hypothesis-generating for further investigations on the effect of these drugs."

Journal • Acute Kidney Injury • Endocrine Disorders • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Nephrology • Oncology • Prostate Cancer • Renal Disease • Solid Tumor

Phenotypic Plasticity and Androgen Receptor Bypass Drive Cross-Resistance to Apalutamide in Castration-Resistant Prostate Cancer Cell Models. (PubMed, Int J Mol Sci) - "The treatment of choice for prostate cancer is androgen deprivation (ADT) and novel hormonal agents such as Abiraterone, Enzalutamide, or Apalutamide. Most CRPC cell models developed cross-resistance to Apalutamide and were able to proliferate and retain their clonogenic capability. Apalutamide resistance was not linked to the expression of AR-V7 or AR-V9 variants but was instead associated to bypass of AR signaling pathway and the emergence of more aggressive expression profiles."

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

Evaluating Treatment Efficacy in Metastatic Hormone-sensitive Prostate Cancer Patients with Visceral Disease: A Systematic Review and Network Meta-analysis. (PubMed, Eur Urol Oncol) - "Treatment intensification with triplet therapy (ADT + docetaxel + darolutamide) provides the greatest OS benefit in mHSPC patients with VD. Doublet regimens incorporating chemotherapy or abiraterone remain viable alternatives. Further prospective studies are needed to refine treatment selection based on VD-specific biology and organ-specific metastatic patterns."

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

A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer (clinicaltrials.gov) - P2 | N=218 | Recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Not yet recruiting ➔ Recruiting

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

Metformin for patients with metastatic prostate cancer starting androgen deprivation therapy: a randomised phase 3 trial of the STAMPEDE platform protocol. (PubMed, Lancet Oncol) - P2/3 | "We did not find significant evidence of an overall survival benefit of adding metformin to standard of care in the overall population of patients with metastatic hormone-sensitive prostate cancer. The side-effect profile of metformin was as expected and consisted mainly of diarrhoea. Adverse metabolic side-effects of ADT were significantly reduced in the metformin group compared with the standard of care group."

Journal • P3 data • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Comparative Effectiveness of First-Line Treatments for Castration-Resistant Prostate Cancer: A Large-Scale Retrospective Study in Japan. (PubMed, Prostate) - "This retrospective study, based on a large-scale Japanese database, indicates that ENZ may be the most effective first-line treatment for Japanese patients with CRPC, especially given its favorable outcomes relative to other treatments. Despite the limitations in the data set, the findings support the use of ABI-ENZ sequential therapy, which may provide additional clinical benefits in terms of overall survival."

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

Clinical Response to Novel Combination of Trastuzumab Deruxtecan and Abiraterone in HER2-Expressing Metastatic Castration-Resistant Prostate Cancer. (PubMed, Oncologist) - "As a result, T-DXd remains underutilized in patients with mCRPC, despite a tumor-agnostic approval for patients with advanced HER2-expressing (IHC 3+) solid tumors. This case highlights the potential of combining T-DXd with androgen receptor pathway inhibitors to overcome treatment resistance and underscores the importance of routine HER2 IHC testing in patients with advanced PCa."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • HER-2

Impact of New Hormonotherapy Drugs in Prostatic Cancer on the Risk of Cardiovascular Events : a Pharmacoepidemiology Study Using the French Health Care Claims Database (clinicaltrials.gov) - P=N/A | N=52000 | Completed | Sponsor: University Hospital, Caen | Active, not recruiting ➔ Completed

Monotherapy • Trial completion • Cardiovascular • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Efficacy and safety of darolutamide versus abiraterone acetate plus prednisone in combination with ADT for mHSPC: a real-world clinical retrospective study. (PubMed, Front Pharmacol) - "The incidence of adverse reactions was similar in the two groups, and there was no grade 3 or above drug-related adverse reactions. In the treatment of mHSPC, DARO + ADT was associated with significant improvement of clinical outcomes versus AAP + ADT, while their safety is comparable."

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

Case Report: Pituitary metastasis from prostate adenocarcinoma: an integrated diagnosis via 68Ga-PSMA PET/CT and methylome analysis. (PubMed, Front Med (Lausanne)) - "The patient subsequently received systemic treatment with androgen deprivation therapy, abiraterone, and docetaxel, achieving an excellent biochemical and imaging response. Integration of histopathological, immunohistochemical, and molecular techniques, such as DNA-methylation profiling, was essential for confirming the diagnosis. Clinicians should remain vigilant for atypical metastatic presentations and leverage advanced diagnostic tools to ensure accurate diagnosis and optimal patient management."

Journal • Endocrine Cancer • Genito-urinary Cancer • Oncology • Pituitary Gland Carcinoma • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

A Rare Presentation of Prostate Cancer: Psoas Muscle Metastasis Without Bone Involvement. (PubMed, Cureus) - "The patient was treated with anti-androgen therapy along with abiraterone and docetaxel and had a positive serologic and radiologic response. This case underscores the importance of recognizing atypical metastatic sites, such as skeletal muscle, in prostate cancer, as they can complicate initial diagnosis and delay management. Understanding the mechanisms of rare metastatic patterns and the diagnostic approaches required is crucial for improving outcomes in prostate cancer patients."

Journal • Genito-urinary Cancer • Oncology • Pain • Prostate Adenocarcinoma • Prostate Cancer • Rhabdomyosarcoma • Sarcoma • Solid Tumor

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 • Castration-Resistant Prostate Cancer • Cerebral Hemorrhage • CNS Disorders • Epilepsy • Genito-urinary Cancer • Hepatocellular Cancer • Oncology • Prostate Cancer • Solid Tumor

OMAHA1: Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) (clinicaltrials.gov) - P3 | N=1200 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

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

A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02) (clinicaltrials.gov) - P1/2 | N=360 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

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

Steroid Sulfatase Regulates Metabolic Reprogramming in Advanced Prostate Cancer. (PubMed, Cancers (Basel)) - "Our study demonstrates STS as a key driver of metabolic reprogramming and flexibility in advanced prostate cancer. Disrupting enhanced mitochondrial respiration via STS presents a promising strategy in improving CRPC treatment."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary 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

Prognostic Nutritional Index and a Blood-Based Prognostic Tool in Prostate Cancer Treated with Abiraterone, Enzalutamide or Cabazitaxel. (PubMed, Medicina (Kaunas)) - "Materials and This retrospective study included mCRPC patients treated with AA, ENZA, or CABA before or after docetaxel. This is the largest study to date in a non-Asian mCRPC population showing that baseline PNI is a strong, independent prognostic factor for survival. The proposed blood-based tool may aid in clinical risk stratification, pending prospective validation."

Journal • Retrospective data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hematological Disorders • Oncology • Prostate Cancer • Solid Tumor