Erleada (apalutamide) / J&J - LARVOL DELTA

Association Between Castration-resistant Prostate Cancer Progression Patterns and Survival Outcomes in Metastatic Castration-sensitive Prostate Cancer: A Post Hoc Analysis of the TITAN Trial. (PubMed, Eur Urol Focus) - P3 | "Prognosis differed between PSA-CRPC and radiographic CRPC in the placebo group, whereas this heterogeneity was less evident in the apalutamide group. Although apalutamide reduced the cumulative incidence of PSA-CRPC, the cumulative incidence of radiographic CRPC remained comparable to that with placebo. Baseline visceral metastasis was associated with radiographic progression, suggesting that these patients may warrant closer imaging surveillance."

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

Eugonadal Progression-Free Survival Following Intensification of Metastasis-Directed Stereotactic Body Radiotherapy with Radioligand Therapy or Androgen Annihilation Therapy: A Comparison of Two Phase II Trials (ASTRO 2026) - P2 | "Whether an alternative strategy of adding androgen annihilation therapy (AAT; apalutamide plus abiraterone plus leuprolide) to SBRT would improve euPFS remains unknown. Both SBRT+RLT and SBRT+AAT improved euPFS over SBRT alone, while SBRT+RLT and SBRT+AAT achieved comparable euPFS. Given the numerical trend in grade =3 AEs favoring SBRT+RLT, in addition to the known quality of life impacts of hormonal therapy, SBRT+RLT appears to be a clinically attractive hormone-therapy sparing intensification strategy in men with oligorecurrent prostate cancer."

P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Apalutamide versus abiraterone acetate in metastatic hormone-sensitive prostate cancer: an international propensity score-matched real-world analysis (ESMO 2026) - No abstract available

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

Outcomes of enzalutamide (ENZ) and apalutamide (APA) in metastatic hormone-sensitive prostate cancer (mHSPC): a Canadian real-world (RW) study (ESMO 2026) - No abstract available

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

Phase 1/2 PETRANHA trial: Saruparib + apalutamide + androgen deprivation therapy (ADT) in patients (pts) with metastatic prostate cancer (PC) (ESMO 2026) - No abstract available

Clinical • Metastases • P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Survival Outcomes and Toxicity with Reduced-Dose ARPI Therapy: Rationale for the ENHANCE Phase III Trial (ASTRO 2026) - "Purpose/Objective(s): Androgen receptor pathway inhibitors (ARPIs), including enzalutamide, apalutamide, darolutamide, and abiraterone, are standard systemic therapies for metastatic hormone-sensitive (mHSPC) and metastatic castration-resistant prostate cancer (mCRPC). In this real-world cohort, ARPI dose reduction was independently associated with superior OS. This data supports the ENHANCE trial. ENHANCE is a UK multi-centre, open-label, phase III randomised non-inferiority trial comparing reduced-dose ARPI (50% standard dose) versus standard-dose ARPI (100%) in patients with mHSPC or mCRPC."

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

N-Terminal Androgen Receptor Antagonists Offer Superior Tumor Suppression on Glioblastoma than C-Terminal Inhibitors (ASTRO 2026) - "While our preliminary data demonstrated good tolerance of the C-terminal AR antagonist (C-ARA) bicalutamide when added to chemoradiotherapy in GBM patients, and animal studies showed excellent tumor control with bicalutamide combined with brain radiotherapy (RT) as a radiosensitizer, bicalutamide (BIC) or enzalutamide (ENZA) in the C-ARA category, when used alone, has resulted in notable failures in mice with orthotopically implanted GBM tumors...ENZA, BIC, and apalutamide (APA) were tested in the C-ARA category. EPI-7386 (EPI) and cinobufagin (CINO) were tested in the N-ARA category... N-ARAs demonstrate higher potency in suppressing GBM proliferation in vitro, with superior effects over C-ARAs in suppressing cancer stem cells and promoting immunostimulation, both of which are essential for GBM therapy. Future in vivo and clinical studies on N-ARAs are warranted."

Brain Cancer • Glioblastoma • Oncology • Solid Tumor • CD133 • IL2 • IL6 • NES • SOX9 • STAT5 • TNFA

Apalutamide and Enzalutamide in Metastatic Hormone-Sensitive Prostate Cancer: A Multicentre UK Cohort (ESMO 2026) - No abstract available

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

Prostate-specific antigen (PSA) response and long-term outcomes in PROTEUS: perioperative apalutamide plus androgen deprivation therapy (APA + ADT) in patients (pts) with high-risk localized/locally advanced prostate cancer (HR LPC) (ESMO 2026) - No abstract available

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

A multicenter, single-arm, phase 2 trial of androgen deprivation therapy in combination with apalutamide in patients with high risk of recurrence after radical prostatectomy (ARES study) (ESMO 2026) - No abstract available

Clinical • Combination therapy • P2 data • Oncology • Prostate Cancer

Perioperative apalutamide (APA) plus androgen deprivation therapy (ADT) with radical prostatectomy plus pelvic lymph node dissection (RP + PLND) vs RP + PLND alone in patients (pts) with high-risk localized or locally advanced prostate cancer (HR LPC/LAPC): PROTEUS Substudy (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

The efficacy and safety of neoadjuvant chemohormonal therapy followed by robot-assisted radical prostatectomy and/or radiation therapy for prostate cancer patients with oligometastasis: A prospective multicenter study (clinicaltrials.gov) - P=N/A | N=30 | Enrolling by invitation | Sponsor: Gifu University | Unknown status ➔ Enrolling by invitation

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

Apalutamide-Associated Cholestatic Liver Injury in Metastatic Prostate Cancer (ACG 2026) - "Unlike abiraterone (androgen biosynthesis inhibitor), it does not carry a specific FDA hepatotoxicity warning or routine liver function test monitoring requirement. Figure: Figure 1. Hepatic recovery over 72 hours demonstrates a 42% reduction in alkaline phosphatase (ALP), with concurrent downtrending transaminases and modest improvement in total bilirubin between admission (Day 0) and Day 3."

Metastases • Castration-Resistant Prostate Cancer • Chronic Obstructive Pulmonary Disease • Genito-urinary Cancer • Hepatology • Hormone Sensitive Prostate Cancer • Hypertension • Immunology • Liver Failure • Oncology • Prostate Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Comparative Pharmacovigilance Analysis of Safety Signals Among Advanced Prostate Cancer Therapies Using FAERS (FDA Adverse Event Reporting System). (PubMed, Curr Oncol) - "A retrospective pharmacovigilance study of FAERS reports evaluated enzalutamide, darolutamide, apalutamide, abiraterone acetate, relugolix, niraparib/abiraterone, talazoparib, rucaparib, cabazitaxel, sipuleucel-T, and lutetium-177 vipivotide. The absence of a detected signal should not be interpreted as evidence of safety or equivalence, as reporting volume, detection bias, and statistical power varied across therapies. Overall, the therapies demonstrated distinct toxicity profiles, which may inform treatment selection, toxicity monitoring, and patient counseling."

Adverse events • Clinical • Journal • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Hematological Disorders • Oncology • Prostate Cancer • Solid Tumor

Impact of BRCA alterations on Androgen Receptor pathway inhibition treatment outcome in advanced prostate cancer. (PubMed, Cancer Res Commun) - "We conducted a retrospective analysis of pooled data from five randomized trials of ARPIs (apalutamide (Apa) or abiraterone acetate (Abi)) across PCa disease settings. While patients with HRR gene alterations benefit from the addition of ARPIs to ADT, they generally have worse outcomes with AR directed therapy than HRR wildtype patients, with patients harboring BRCA alterations doing particularly poorly. These findings underline the unmet need for new and combination approaches for these patients."

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

BrUOG360: A phase Ib/II study of copanlisib combined with rucaparib in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). (ASCO-GU 2022) - P1/2 | " Enrollment criteria included progressive mCRPC, prior androgen inhibitors (abiraterone, enzalutamide, and/or apalutamide); prior taxane chemotherapy was allowed...Seven pts (63%) received prior chemotherapy (docetaxel [7], cabazitaxel [3])... The combination of rucaparib and copanlisib is well tolerated. The RP2D was rucaparib 400mg BID with copanlisib 45mg (D1, D15; 28-day cycle) with signal of efficacy. Enrollment in a phase 2 expansion cohort in HR-mutated mCRPC is ongoing."

Clinical • P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • CDK12 • FANCA • PALB2

BrUOG360: A phase Ib/II study of copanlisib combined with rucaparib in patients with metastatic castration-resistant prostate cancer (mCRPC) (AACR 2023) - P1/2 | "We describe preliminary results of a phase Ib/II study investigating safety of the combination of copanlisib (pan-class I PI3Ki) and rucaparib (PARP-1, -2 and -3 inhibitor). Enrollment criteria included progressive mCRPC, prior androgen inhibitors (abiraterone, enzalutamide, and/or apalutamide); prior taxane chemotherapy was allowed...Nine patients (69%) received prior chemotherapy (docetaxel [6], cabazitaxel [3])... The combination of rucaparib and copanlisib is well tolerated. The RP2D was rucaparib 400mg BID with copanlisib 45mg (D1, D15; 28-day cycle) with signal of efficacy in patients with and without HRD. Clinical trial information: NCT04253262."

Clinical • Metastases • P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • CDK12 • FANCA • PALB2

ProstACT Global: A phase 3 study of Lutetium (Lu177) rosopatamab tetraxetan plus SoC vs SoC alone in patients with metastatic castration-resistant prostate cancer (SUO 2025) - P3 | "In Part 1, patients are divided into 3 groups (n=10 each) to receive 2 single intravenous injections of 76 mCi each, 14d apart, of 177 Lu-rosopatamab with standard of care (SoC) combinations with abiraterone, enzalutamide, or docetaxel to characterize biodistribution & safety profiles of 177 Lu-rosopatamab + SoC combinations...Eligible patients must have PSMA-expressing mCRPC and have experienced disease progression on a minimum 12w prior therapy on their 1 st ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide) in metastatic castration-sensitive PC, non-metastatic CRPC, or mCRPC settings...This study is sponsored by Telix Pharmaceuticals and is currently enrolling in Part 1. ClinicalTrials.gov ID: NCT06520345 "

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

Systemic and Tumor-directed Therapy for Oligorecurrent Metastatic Prostate Cancer (SATURN): Primary Endpoint Results from a Phase 2 Clinical Trial. (PubMed, Eur Urol) - P2 | "Patients received 6 mo of androgen annihilation therapy (AAT; leuprolide, abiraterone acetate plus prednisone, and apalutamide) and metastasis-directed SBRT. Overall, this appears to be an effective therapy with acceptable side effects. This trial is registered on ClinicalTrials.gov as NCT03902951."

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

Health-related quality of life (HRQOL) results from PRESTO (AFT-19), a phase 3 randomized trial of intensification of androgen blockade in patients with high-risk biochemically relapsed castration sensitive prostate cancer. (ASCO 2024) - P3 | "Background: The PRESTO trial (NCT03009981) showed that in patients with biochemically relapsed prostate cancer following radical prostatectomy with a PSA doubling time of ≤ 9 months and without evidence of metastatic disease by conventional imaging, intensified androgen receptor blockade for 52 weeks (androgen deprivation therapy [ADT] plus apalutamide [Apa], or ADT plus Apa and abiraterone acetate [Abi] plus prednisone) prolonged PSA progression-free survival compared to ADT alone (Aggarwal et al, JCO 2024). Intensified androgen receptor blockade with Apa or Apa/Abi added to 52 weeks of ADT improves PSA progression-free survival without negatively affecting HRQOL. These HRQOL results add further support to intensification of androgen blockade in patients with high-risk biochemically recurrent prostate cancer."

Clinical • HEOR • P3 data • Fatigue • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR

Oncologic Outcomes in a Contemporary "PROTEUS-like" Cohort of High-risk Prostate Cancer Treated with Radical Prostatectomy Without Neoadjuvant Hormonal Therapy. (PubMed, Eur Urol Open Sci) - P3 | "The PROTEUS (NCT03767244) trial evaluates perioperative apalutamide + androgen deprivation therapy (ADT) but lacks a surgery-only control cohort...Limitations include the retrospective, single-center design, absence of centralized pathology review, and maturing follow-up. These findings demonstrate substantial rates of recurrence and metastatic progression despite contemporary management, underscoring the persistent unmet need in this population and providing a rationale for prospective evaluation of perioperative treatment intensification strategies such as PROTEUS."

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

Expression of nectin-4 in squamous cell carcinoma of prostate: a pilot study and case report. (PubMed, Front Oncol) - "In the current case, although apalutamide, a novel androgen receptor inhibitor, in combination with ADT and pelvic radiotherapy was administered 1 month postoperatively, the patient experienced both biochemical and radiographic progression. This is the first report of a case of hormonal therapy-induced SCCP, in which Nectin-4 was expressed exclusively in the squamous component, not the glandular component. Nectin-4 might be a therapeutic target for SCCP."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • NECTIN4

Safety and tolerability of relugolix in combination with abiraterone or apalutamide for treatment of advanced prostate cancer: Data from a 52-week clinical trial. (ASCO-GU 2025) - P1 | "REL used in combination with ABI or APA showed safety profiles consistent with individual drugs over 52 wks. REL levels were stable, and testosterone was sustained below castration level. These findings support the safety and tolerability of REL combination therapy with ABI or APA for aPC."

Clinical • Combination therapy • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Intensified hormonal blockade with SBRT in PSMA-PET detected oligometastatic prostate adenocarcinoma: Results from the phase II Metacure trial cohorts B2 and the B2 expansion. (ASCO 2025) - P2 | "Cohort B2 randomized pts to metastasis-directed SBRT with either 10 months of ADT + apalutamide + abiraterone acetate plus prednisone (ADT+APA+AAP) or ADT + apalutamide (ADT+APA). SBRT with short course intensified hormonal blockade was well tolerated and led to durable disease control in pts with PSMA PET-detected metachronous oligometastatic prostate cancer."

Metastases • P2 data • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer

Burden of Treatment-Induced Vasomotor Symptoms in Men With Prostate Cancer on Androgen-Deprivation Therapy: A Systematic Literature Review. (PubMed, Prostate Cancer) - "Lower frequencies were seen when VMS were spontaneously captured or in retrospective analyses without active VMS monitoring/reporting (1.4%-15.8%) and with enzalutamide, apalutamide, and abiraterone as add-on therapy to ADT (13.9%-15.8%). VMS severity in men with PCa is more consistently associated with QoL impact versus VMS frequency. A need for PRO instruments specific to treatment-related VMS in PCa and a lack of consensus on definitions of severity for ADT-induced VMS in PCa were identified."

Journal • Review • CNS Disorders • Fatigue • Genito-urinary Cancer • Insomnia • Mood Disorders • Oncology • Prostate Cancer • Psychiatry • Sleep Disorder • Solid Tumor