abiraterone acetate / Generic mfg. - LARVOL DELTA

TRIPLE-SWITCH (SWOG/CCTG-PR26): A randomized phase III clinical trial for the addition of docetaxel to androgen receptor pathway inhibitors in patients with metastatic castration sensitive prostate cancer (mCSPC) and suboptimal PSA response (NCT06592924). (ASCO 2025) - P3 | "Arm 1 will continue standard ADT + ARPI (abiraterone acetate with prednisone, apalutamide, enzalutamide or darolutamide). Correlative studies will explore the prognostic and predictive value of circulating tumor DNA (ctDNA) and the association between molecular signatures in primary prostate cancer tissue and clinical outcomes. Enrolment has been initiated in January 2025 and is ongoing."

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

Prognostic significance of PSA>0.2 after 6-12 months treatment for metastatic hormone-sensitive prostate cancer (mHSPC) intensified by androgen-receptor pathway inhibitors (ARPI): A multinational real-world analysis of the IRONMAN registry. (ASCO 2025) - "Intensification agents were: abiraterone acetate (576, 44.7%), apalutamide (283, 22.0%), darolutamide (135, 10.5%), or enzalutamide (294, 22.8%), and 122 (8.7%) received docetaxel in addition to ADT-ARPI. IRONMAN provides large real-world data validating the poor prognosis of mHSPC with PSA>0.2 after 6-12 months ADT-ARPI treatment and these patients could be targeted for intensification in future trials. Conversely, PSA<0.02 at 6-12 months defines the best prognosis and may be of interest for de-intensification strategies. OS and PFS outcomes by 12-month PSA strata."

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

First interim efficacy analysis of the phase I/II PETRANHA trial of saruparib + androgen receptor pathway inhibitors (ARPI) in patients (pts) with metastatic prostate cancer (mPC) (ESMO 2025) - P1/2 | "Methods Pts, allocated by investigator choice, received saruparib 60 mg once daily (OD) + enzalutamide 160 mg OD (Arm 1), abiraterone 1000 mg OD + 5 mg prednisone OD or twice daily (BD; Arm 2), or darolutamide 600 mg BD (Arm 3) until disease progression or intolerable adverse event (AE)...Arm 4 (+ apalutamide 240 mg OD) is ongoing dose escalation and was not included in this analysis...EvoPAR-01 is an ongoing phase 3 study evaluating this combination in mCSPC. Table: 2384MO mCRPC Prior ARPI N=19 mCRPC ARPI-naïve N=31 mCSPC N=27 Median duration of saruparib / ARPI exposure, months (range) 5.5 (1.2–17.7) / 5.5 (1.1–17.7) 14.7 (0.3–24.8) / 15.7 (0.4–24.8) 17.8 (0.2–28.2) / 19.7 (0.2–28.2) Any AE, n (%) 18 (94.7) 31 (100) 26 (96.3) Any AE causally related to saruparib, n (%) 16 (84.2) 28 (90.3) 23 (85.2) Any AE Gr ≥3, n (%) 6 (31.6) 16 (51.6) 14 (51.9) Any serious AE, n (%) 4 (21.1) 10 (32.3) 4 (14.8) Saruparib / ARPI discontinuation due to AE, n (%) 1 (5.3) / 1..."

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

A phase III study of capivasertib (capi) + abiraterone (abi) vs placebo (pbo) + abi in patients (pts) with PTEN deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC): CAPItello-281 (ESMO 2025) - P3 | "The safety profile was broadly consistent with the known profiles of capi and abi. Capi in combination with abi represents a potential first-in-class targeted treatment for this poor prognosis population with high unmet need."

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

Final results from PRESTO: A phase III open-label study of combined androgen blockade in patients (pts) with high-risk biochemically relapsed prostate cancer (BRPC) (AFT-19) (ESMO 2025) - P3 | "Background Prior analyses of PRESTO demonstrated that apalutamide (APA) prolonged PSA progression-free survival (PSA-PFS) without negatively impacting quality of life (QOL) in pts with high-risk BRPC...Pts were randomized 1:1:1 to receive a finite 52-week treatment course with androgen deprivation therapy (ADT), ADT + APA, or ADT + APA + abiraterone acetate with prednisone (AAP)...The difference in RMST over the first 48 months for MFS between ADT + APA vs ADT was 2.92 months (95% CI: 0.45 – 5.39) and for ADT + APA + AAP vs ADT was 2.41 months (95% CI: -0.20 – 4.62). Table: LBA88 Endpoint Comparison Hazard Ratio 95% CI Metastasis-free survival ADT + APA vs ADT 0.80 0.56 – 1.13 ADT + APA + AAP vs ADT 0.92 0.66 – 1.28 Time to castration resistance ADT + APA vs ADT 0.58 0.36 – 0.95 ADT + APA + AAP vs ADT 0.55 0.34 – 0.90 Time to subsequent treatment ADT + APA vs ADT 0.75 0.56 – 1.00 ADT + APA + AAP vs ADT 0.64 0.47 – 0.86 PSA-PFS in the testosterone-recovered subset..."

Clinical • Late-breaking abstract • P3 data • Genito-urinary Cancer • Oncology • Prostate Cancer

STARLiT: A Single Arm Phase I/II Trial of STereotActic Body Radiotherapy and 177 Lutetium PSMA in Locally Advanced Prostate Cancer (ASTRO 2025) - "The most common treatment for this patient subset is radiation therapy (RT) plus long-term androgen deprivation therapy (ADT) for 18-36 months with consideration for the addition of abiraterone acetate...STARLiT aims to evaluate the safety of combining 177Lu-PSMA-617 with SBRT to the prostate and to determine whether 177Lu-PSMA-617 can replace ADT to improve disease control by use of cytotoxic agents, avoid side effects and improve patient compliance to receive systemic therapy... The trial was activated in February 2025 and aims to complete accrual within 18 months with a 5-year follow-up."

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

Patient reported outcomes (PRO) and tolerability of capivasertib (capi) plus abiraterone (abi) versus placebo (pbo) plus abi in patients (pts) with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC): CAPItello-281. (ASCO-GU 2026) - P3 | "Clinical Trial Registry Number: NCT04493853. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

Clinical • Metastases • Patient reported outcomes • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • PTEN

Randomized Three-Arm Trial to Evaluate the Effect of Neoadjuvant Apalutamide Alone or in Combination with Abiraterone Acetate and GnRH Agonist on Enhancing Surgical Outcome of Nerve-Sparing Radical Prostatectomy in Men with High-Risk Prostate Can (AUA 2025) - P2 | "We report the outcomes of a prospective randomized trial evaluating the effect of neoadjuvant Apalutamide (Apa) +/- abiraterone acetate/prednisone (AAP) and a gonadotropin-releasing hormone (GnRH) agonist on nerve sparing during RP in men with high-risk PCa. Early analysis of the study suggest that neoadjuvant apalutamide prior to surgery resulted in faster continence recovery without compromising surgical outcomes or safety for patients with High risk PCa undergoing nerve sparing RP. Final analysis will be conducted in June 2025."

Clinical • Combination therapy • Prostate Cancer

Prognostic and predictive value of baseline PSMA-PET total tumour volume and SUVmean in metastatic castration-resistant prostate cancer in ENZA-p (ANZUP1901): a substudy from a multicentre, open-label, randomised, phase 2 trial. (PubMed, Lancet Oncol) - P2 | "Baseline PSMA-TTV is prognostic for overall survival and predictive for a beneficial effect on overall survival with the addition of [177Lu]Lu-PSMA-617 to enzalutamide as first-line treatment for high-risk metastatic castration-resistant prostate cancer. By contrast, PSMA SUVmean was not prognostic for PSA progression-free survival or overall survival when [177Lu]Lu-PSMA-617 was administered with enzalutamide."

Journal • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary 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

IDeate-Prostate02: A PHASE 1/2, OPEN-LABEL UMBRELLA SUBSTUDY OF IFINATAMAB DERUXTECAN-BASED TREATMENT COMBINATIONS OR AS MONOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY TREATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (SUO 2025) - P1/2 | "Two monotherapy arms (Arm 1 [docetaxel] and Arm 2 [I-DXd]) will enroll participants into the Efficacy Phase, and 2 I-DXd combination arms (Arm 3: I-DXd+MK-5684; and Arm 4: I-DXd+ARPI [abiraterone acetate or enzalutamide; prior treatment dependent]) will enroll into the Safety Lead-in, followed by Efficacy Phase. Recruitment is ongoing. "

Clinical • Metastases • Monotherapy • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD276

SATURN: Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer (clinicaltrials.gov) - P2 | N=28 | Active, not recruiting | Sponsor: Jonsson Comprehensive Cancer Center | Trial completion date: Jan 2027 ➔ Jan 2028 | Trial primary completion date: Jan 2026 ➔ Jan 2027

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

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

A Phase I Clinical Trial Evaluating the Safety and Dosing of Relugolix with Novel Hormonal Therapy for the Treatment of Advanced Prostate Cancer. (PubMed, Target Oncol) - P1 | "Combination therapy of relugolix and abiraterone or apalutamide was associated with a favorable safety and tolerability profile consistent with the known profiles of the individual medications. Castration levels of testosterone were maintained after transitioning to relugolix from other ADTs."

Journal • Metastases • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety and Tolerability of Relugolix in Combination with Abiraterone or Apalutamide for Treatment of Patients with Advanced Prostate Cancer: Data from a 52-Week Clinical Trial. (PubMed, Target Oncol) - P1 | "The safety/tolerability profile of both combination therapies was consistent with those of the individual drugs. These findings support using relugolix in combination with abiraterone or apalutamide as treatment of aPC."

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

Final overall survival (OS) with talazoparib (TALA) + enzalutamide (ENZA) as first-line treatment in unselected patients with metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 TALAPRO-2 trial. (ASCO-GU 2025) - P3 | " In cohort 1, pts were randomized 1:1 to ENZA 160 mg + either TALA 0.5 mg (0.35 mg if moderate renal impairment) or PBO once daily and stratified by prior abiraterone or docetaxel (yes/no) for castration-sensitive PC and HRR gene alteration status. TALA + ENZA demonstrated a statistically significant and clinically meaningful improvement in OS vs standard-of-care ENZA as 1L treatment in pts with mCRPC unselected for HRR gene alterations. rPFS continued to favor TALA + ENZA. No new safety signals were identified with extended follow-up."

Clinical • Late-breaking abstract • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • HRD

Efficacy of docetaxel addition to next-generation androgen receptor-axis-targeted therapies and androgen deprivation therapy in metastatic hormone-sensitive prostate cancer: A tumor volume-specific analysis. (PubMed, Int J Urol) - "Patients with mHSPC did not show significant improvement with docetaxel addition to ARAT-based regimens, regardless of tumor volume. Further research is needed to identify potential beneficiaries of this combination therapy."

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

Mevrometostat (PF-06821497), an enhancer of zeste homolog 2 (EZH2) inhibitor, in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC): A randomized dose-expansion study. (ASCO-GU 2025) - P1 | " Pts with mCRPC who received prior abiraterone, ≤1 prior chemotherapy in any setting, with evidence of progression per modified Prostate Cancer Working Group 3 criteria were included. M+E shows improved outcomes vs E in pts with mCRPC, with a manageable AE profile. In M+E combination, M 875 mg with food has similar plasma exposure as M 1250 mg on empty stomach. Further investigation of M+E in pts with mCRPC is warranted."

Clinical • Combination therapy • Late-breaking abstract • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Overall survival and quality of life with [177Lu]Lu-PSMA-617 plus enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer (ENZA-p): secondary outcomes from a multicentre, open-label, randomised, phase 2 trial. (PubMed, Lancet Oncol) - P2 | "The addition of [177Lu] Lu-PSMA-617 to enzalutamide was associated with improved survival and some aspects of HRQOL in patients with high-risk metastatic castration-resistant prostate cancer. Our findings warrant phase 3 evaluation of adaptive-dosed [177Lu] Lu-PSMA-617 in combination with androgen receptor pathway inhibitors in people with metastatic prostate cancer."

HEOR • Journal • P2 data • Castration-Resistant Prostate Cancer • Dental Disorders • Fatigue • Genito-urinary Cancer • Oncology • Pain • Prostate Cancer • Solid Tumor • Xerostomia

First-line talazoparib plus enzalutamide versus placebo plus enzalutamide for metastatic castration-resistant prostate cancer: patient-reported outcomes from the randomised, double-blind, placebo-controlled, phase 3 TALAPRO-2 trial. (PubMed, Lancet Oncol) - P3 | "Talazoparib plus enzalutamide prolonged time to definitive deterioration in GHS/QoL versus placebo plus enzalutamide. Together with clinical efficacy and safety data, these results inform the risk-benefit assessment of talazoparib plus enzalutamide in patients with metastatic castration-resistant prostate cancer in TALAPRO-2."

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

Predictive and prognostic value of baseline PSMA-PET total tumor volume and SUV mean within ENZA-p, a randomized phase II trial of enzalutamide versus enzalutamide plus [177Lu] Lu-PSMA-617 (ANZUP1901). (ASCO 2025) - P2 | "Participants (pts) with mCRPC not previously treated with chemotherapy or AR antagonist (abiraterone permitted) and [68Ga]Ga-PSMA-avid disease were randomized (1:1) to either enza-alone or enza + LuPSMA using adaptive-dosed [177]Lu LuPSMA-617 7.5 GBq for (2 or 4 doses). Baseline PSMA-TTV was prognostic of shorter OS with enza-alone, but not with the addition of LuPSMA-617. In contrast to LuPSMA-617 monotherapy, PSMA SUVmean was neither predictive nor prognostic of improved OS, nor of PSA-PFS when LuPSMA-617 was given together with enza as first line treatment for mCRPC."

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

Multimodal artificial intelligence (MMAI) model to identify benefit from 2nd-generation androgen receptor pathway inhibitors (ARPI) in high-risk non-metastatic prostate cancer patients from STAMPEDE. (ASCO 2025) - P2/3 | "Funded by Prostate Cancer Foundation, Artera, Inc., John Black Charitable Foundation, UK Medical Research Council, Prostate Cancer UK, Cancer Research UK, Sanofi Aventis, Janssen, Astellas, Novartis Clinical Trial Registration Number: NCT00268476 Background: The STAMPEDE trials showed that adding abiraterone acetate + prednisolone (AAP) ± enzalutamide (ENZ) to standard of care androgen deprivation therapy (SOC) improves metastasis-free survival (MFS) in high-risk non-metastatic (M0) prostate cancer (PCa) patients (pts). For the first time, we demonstrate that a validated MMAI algorithm can identify high-risk non-metastatic PCa pts most likely to benefit from the addition of ARPI. Notably we identify a positive biomarker-treatment interaction in the highest MMAI score quartile, which in cases of clinical equipoise could inform clinical decision-making. We highlight MMAI's potential to optimize treatment decisions & spare biomarker-neg pts from..."

Clinical • 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

Pooled Analysis of the SOLAR and SATURN Clinical Trials Comparing Progression of Synchronous Versus Metachronous Prostate-specific Membrane Antigen-defined Oligometastatic Prostate Cancer Following Systemic and Tumor-directed Therapy. (PubMed, Eur Urol Oncol) - P2 | "All patients received 6 mo of intensified systemic therapy (leuprolide, abiraterone acetate with prednisone, and apalutamide) and stereotactic body radiotherapy to oligometastases. Among 50 patients (24 synchronous and 26 metachronous), the synchronous omCSPC group had a significantly higher PSA response rate (83% vs 50%; p = 0.018) and significantly longer PFS and eugonadal PFS (p < 0.05). The metachronous subgroup with prior ADT had worse outcomes, suggesting increasing resistance with repeated systemic therapy."

Journal • Retrospective data • Genito-urinary 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