Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension

18d

Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment (clinicaltrials.gov)

P1, N=10, Active, not recruiting, Eli Lilly and Company | Recruiting --> Active, not recruiting | N=50 --> 10 | Trial completion date: Nov 2025 --> Jul 2026 | Trial primary completion date: Dec 2024 --> Feb 2024

18 days ago

Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases

Verzenio (abemaciclib) • Nubeqa (darolutamide)

28d

Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)

P1/2, N=54, Recruiting, Celcuity Inc | Not yet recruiting --> Recruiting

28 days ago

Enrollment open • Combination therapy • Metastases

gedatolisib (PF-05212384) • Nubeqa (darolutamide)

28d

ARENA: An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetastatic Prostate Cancer in Routine Medical Care in the United States (clinicaltrials.gov)

P=N/A, N=1800, Completed, Bayer | Active, not recruiting --> Completed

28 days ago

Trial completion • Metastases

Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide)

EORTC-1532: ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer (clinicaltrials.gov)

P2, N=61, Active, not recruiting, European Organisation for Research and Treatment of Cancer - EORTC | Trial completion date: May 2024 --> Dec 2036

1 month ago

Trial completion date

Nubeqa (darolutamide) • triptorelin • goserelin acetate • Firmagon (degarelix)

An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea (clinicaltrials.gov)

P=N/A, N=600, Not yet recruiting, Bayer

1 month ago

New trial

Nubeqa (darolutamide)

2ms

Discovery of Novel Anti-Resistance AR Antagonists Guided by Funnel Metadynamics Simulation. (PubMed, Adv Sci (Weinh))

Here, funnel metadynamics is employed to elucidate the inherent regulation mechanisms of three AR antagonists (hydroxyflutamide, enzalutamide, and darolutamide) on AR. Subsequently, docking-based virtual screening toward the dominant binding conformation of AR for darolutamide is conducted, and three novel AR antagonists with favorable binding affinity and strong capability to combat drug resistance are identified by in vitro bioassays. This work provides a novel rational strategy for the development of anti-resistant AR antagonists.

2 months ago

Journal

AR (Androgen receptor)

AR mutation

Xtandi (enzalutamide capsule) • Nubeqa (darolutamide)

2ms

SAKK 08/16: ODM-201 Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents. (clinicaltrials.gov)

P2, N=92, Terminated, Swiss Group for Clinical Cancer Research | Trial completion date: Dec 2026 --> Nov 2023 | Active, not recruiting --> Terminated; Decision Board no further financial support after 3 years of follow-up as remaining patients in follow-up phase would not relevantly change the endpoints.

2 months ago

Trial completion date • Trial termination • Metastases

Nubeqa (darolutamide)

2ms

ALADDIN: Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases (clinicaltrials.gov)

P3, N=152, Recruiting, Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie | Not yet recruiting --> Recruiting

2 months ago

Enrollment open

Nubeqa (darolutamide)

2ms

Carboplatin in patients with metastatic castration-resistant prostate cancer (mCRPC) harbouring somatic or germline homologous recombination repair (HRR) gene mutations: Protocol for a phase II single-arm trial. (PubMed, JMIR Res Protoc)

This prospective phase II trial represents a critical step towards addressing the therapeutic gap in mCRPC patients harboring HRR pathway mutations, particularly in demographic regions with limited access to PARP inhibitors. Outcomes from this study will inform clinical practice and guide future phase III randomized trials, ultimately improving patient outcomes globally.

2 months ago

P2 data • Journal • PARP Biomarker • Metastases

HRD (Homologous Recombination Deficiency)

Lynparza (olaparib) • carboplatin • docetaxel • Xtandi (enzalutamide capsule) • Rubraca (rucaparib) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide)

2ms

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial (clinicaltrials.gov)

P1, N=2, Terminated, OHSU Knight Cancer Institute | Active, not recruiting --> Terminated; Low accrual

2 months ago

Trial termination

Keytruda (pembrolizumab) • Opdivo (nivolumab) • Avastin (bevacizumab) • Venclexta (venetoclax) • Lynparza (olaparib) • Mekinist (trametinib) • erlotinib • Gilotrif (afatinib) • Yervoy (ipilimumab) • Ibrance (palbociclib) • dasatinib • Zelboraf (vemurafenib) • Tafinlar (dabrafenib) • carboplatin • Imfinzi (durvalumab) • sorafenib • Rozlytrek (entrectinib) • imatinib • sunitinib • everolimus • Nerlynx (neratinib) • Iclusig (ponatinib) • Kadcyla (ado-trastuzumab emtansine) • Cotellic (cobimetinib) • Lorbrena (lorlatinib) • Lenvima (lenvatinib) • bortezomib • doxorubicin hydrochloride • capecitabine • Verzenio (abemaciclib) • Xtandi (enzalutamide capsule) • Cabometyx (cabozantinib tablet) • albumin-bound paclitaxel • Stivarga (regorafenib) • abiraterone acetate • oxaliplatin • Aliqopa (copanlisib) • Vizimpro (dacomitinib) • Zydelig (idelalisib) • daunorubicin • Zolinza (vorinostat) • Idhifa (enasidenib) • Farydak (panobinostat) • Erivedge (vismodegib) • Nubeqa (darolutamide) • bicalutamide • leucovorin calcium • cabazitaxel • Vesanoid (tretinoin) • fluorouracil topical

2ms

ARASEC: A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study. (clinicaltrials.gov)

P2, N=223, Active, not recruiting, Bayer | Trial primary completion date: Jun 2024 --> Dec 2024

2 months ago

Trial primary completion date • Metastases

Nubeqa (darolutamide)

2ms

Prostate Cancer Biomarker Enrichment and Treatment Selection (clinicaltrials.gov)

P2, N=200, Active, not recruiting, Canadian Cancer Trials Group | Recruiting --> Active, not recruiting | N=600 --> 200

2 months ago

Enrollment closed • Enrollment change

carboplatin • Imfinzi (durvalumab) • Imjudo (tremelimumab) • adavosertib (AZD1775) • Orpathys (savolitinib) • ipatasertib (RG7440) • Nubeqa (darolutamide) • ocifisertib (CFI-400945)

2ms

Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer (clinicaltrials.gov)

P1/2, N=93, Active, not recruiting, Praful Ravi, MB BCHir, MRCP | Recruiting --> Active, not recruiting

2 months ago

Enrollment closed

Verzenio (abemaciclib) • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • goserelin acetate • Firmagon (degarelix)

2ms

THUNDER: Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (clinicaltrials.gov)

P2/3; N=493; Recruiting; Sponsor:Cancer Research Antwerp

2 months ago

New P2/3 trial

Decipher Prostate Cancer Test

docetaxel • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • triptorelin • goserelin acetate • Firmagon (degarelix)

2ms

PEACE8: Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging (clinicaltrials.gov)

P3, N=336, Not yet recruiting, UNICANCER

2 months ago

New P3 trial

Nubeqa (darolutamide)

2ms

Comparative real-world (RW) evidence on darolutamide (Daro), enzalutamide (Enza), and apalutamide (Apa) for patients (Pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC) in the United States: DEAR. (DKK 2024)

"A lower % of pts discontinued initial ARI tx, progressed to metastasis, or had AEs on daro vs enza/apa. When adjusting for observed BL factors, pts on daro had considerably lower risk of DISC and PROG vs enza/apa. This study confirms daro’s strong efficacy and favorable tolerability profile in a RW setting."

2 months ago

Real-world evidence • Clinical

Xtandi (enzalutamide capsule) • Nubeqa (darolutamide) • Erleada (apalutamide)

3ms

Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial) (clinicaltrials.gov)

P2, N=51, Active, not recruiting, Latin American Cooperative Oncology Group | Trial primary completion date: Jun 2024 --> Feb 2024

3 months ago

Trial primary completion date • Metastases

Nubeqa (darolutamide)

3ms

CRISPR genome-wide screening identifies PAK1 as a critical driver of ARSI cross-resistance in prostate cancer progression. (PubMed, Cancer Lett)

Next-generation androgen receptor signaling inhibitors (ARSIs), such as enzalutamide (Enza) and darolutamide (Daro), are initially effective for the treatment of advanced prostate cancer (PCa) and castration-resistant prostate cancer (CRPC). Our findings indicate that PAK1 represents a promising therapeutic target gene for the treatment of ARSI cross-resistant PCa patients in the clinic. STATEMENT OF SIGNIFICANCE: PAK1 drives ARSI cross-resistance in prostate cancer progression.

3 months ago

Journal

RELA (RELA Proto-Oncogene)

AR splice variant 7 • AR-V7 expression • AR splice variant 7 expression

Xtandi (enzalutamide capsule) • Nubeqa (darolutamide)

3ms

NRG-GY033: Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors (clinicaltrials.gov)

P2, N=37, Recruiting, National Cancer Institute (NCI) | Initiation date: Oct 2024 --> Feb 2024

3 months ago

Trial initiation date • Combination therapy

ER (Estrogen receptor) • PGR (Progesterone receptor)

exemestane • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • Viadur (leuprorelin implant)

3ms

Prostate Cancer Biomarker Enrichment and Treatment Selection (clinicaltrials.gov)

P2, N=600, Recruiting, Canadian Cancer Trials Group | Trial completion date: Jul 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024

3 months ago

Trial completion date • Trial primary completion date

carboplatin • Imfinzi (durvalumab) • Imjudo (tremelimumab) • adavosertib (AZD1775) • Orpathys (savolitinib) • ipatasertib (RG7440) • Nubeqa (darolutamide) • ocifisertib (CFI-400945)

3ms

Addressing the risk and management of cardiometabolic complications in prostate cancer patients on androgen deprivation therapy and androgen receptor axis-targeted therapy: consensus statements from the Hong Kong Urological Association and the Hong Kong Society of Uro-Oncology. (PubMed, Front Oncol)

The panel reached a consensus on 18 statements based on recent evidence and expert insights. These consensus statements serve as a practical recommendation for clinicians in Hong Kong, and possibly the Asia-Pacific region, in the management of cardiometabolic toxicities of ADT or AR axis-targeted therapies in men with PCa.

3 months ago

Review • Journal

AR (Androgen receptor)

Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide) • Firmagon (degarelix) • leuprolide acetate for depot suspension

3ms

Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment (clinicaltrials.gov)

P1, N=50, Recruiting, Eli Lilly and Company | Not yet recruiting --> Recruiting

3 months ago

Enrollment open

Verzenio (abemaciclib) • Nubeqa (darolutamide)

3ms

NRG-GY033: Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors (clinicaltrials.gov)

P2, N=37, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting

3 months ago

Enrollment open

ER (Estrogen receptor) • PGR (Progesterone receptor)

exemestane • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • Viadur (leuprorelin implant)

3ms

P=N/A, N=1800, Active, not recruiting, Bayer | Not yet recruiting --> Active, not recruiting

3 months ago

Enrollment closed • Metastases

Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide)

4ms

A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described (clinicaltrials.gov)

P=N/A, N=805, Active, not recruiting, Bayer | Recruiting --> Active, not recruiting

4 months ago

Enrollment closed • Metastases

Nubeqa (darolutamide)

4ms

Dual targeting of the androgen receptor and PI3K/AKT/mTOR pathways in prostate cancer models improves antitumor efficacy and promotes cell apoptosis. (PubMed, Mol Oncol)

Combination treatment with the AR inhibitor darolutamide led to enhanced apoptosis in these cell lines, the effects being most pronounced upon cotreatment with the pan-PI3K inhibitor copanlisib. Importantly, immunohistochemistry analysis of these treated tumors showed increased apoptosis, as revealed by elevated levels of cleaved caspase 3 and Bcl-2-binding component 3 (BBC3). In conclusion, these data demonstrate that concurrent blockade of the PI3K/AKT/mTOR and AR pathways has superior antitumor efficacy and induces apoptosis in androgen-sensitive prostate cancer cell lines and PDX models.

4 months ago

Preclinical • Journal • IO biomarker

BCL2 (B-cell CLL/lymphoma 2) • AR (Androgen receptor) • CASP3 (Caspase 3) • CASP7 (Caspase 7) • BBC3 (BCL2 Binding Component 3)

Aliqopa (copanlisib) • Nubeqa (darolutamide)

4ms

A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real World Conditions When Taken in Addition to Standard Androgen Deprivation Therapy (ADT) in Indian Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) (clinicaltrials.gov)

P4, N=50, Recruiting, Bayer | Trial completion date: Sep 2024 --> Jan 2026 | Trial primary completion date: Sep 2024 --> Jan 2026

4 months ago

Trial completion date • Trial primary completion date • Real-world evidence • Real-world • Metastases

Nubeqa (darolutamide)

4ms

P=N/A, N=1800, Not yet recruiting, Bayer

4 months ago

New trial • Metastases

Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide)

4ms

A Study Called ARAMON to Learn to What Extent Does Study Treatment With Darolutamide Affects Testosterone Levels in Men With Prostate Cancer That Had Not Been Treated With Hormonal Therapy Compared to Treatment With Enzalutamide (clinicaltrials.gov)

P2, N=65, Recruiting, Bayer | Trial completion date: Oct 2025 --> May 2026 | Trial primary completion date: Oct 2024 --> Aug 2025

4 months ago

Trial completion date • Trial primary completion date

Xtandi (enzalutamide capsule) • Nubeqa (darolutamide)

4ms

Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment (clinicaltrials.gov)

P1, N=50, Not yet recruiting, Eli Lilly and Company | Phase classification: P1b --> P1 | Trial completion date: Jul 2026 --> Nov 2025

4 months ago

Phase classification • Trial completion date • Metastases

Verzenio (abemaciclib) • Nubeqa (darolutamide)

4ms

Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)

P1/2, N=54, Not yet recruiting, Celcuity Inc

4 months ago

New P1/2 trial • Combination therapy • Metastases

gedatolisib (PF-05212384) • Nubeqa (darolutamide)

5ms

Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC (clinicaltrials.gov)

P3, N=200, Recruiting, The First Affiliated Hospital with Nanjing Medical University

5 months ago

New P3 trial

Nubeqa (darolutamide)

5ms

EvoPAR-PR01: AZD5305 vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents (clinicaltrials.gov)

P3, N=1800, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting

5 months ago

Enrollment open

Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • saruparib (AZD5305)

5ms

SUGAR: SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer (clinicaltrials.gov)

P2, N=240, Recruiting, Institut Claudius Regaud

5 months ago

Trial completion date • Trial primary completion date • Surgery • Metastases

Nubeqa (darolutamide)

5ms

Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer (clinicaltrials.gov)

P2, N=75, Recruiting, Mamta Parikh

5 months ago

New P2 trial

abiraterone acetate • Nubeqa (darolutamide)

5ms

Clinical and patient factors associated with treatment intensification for metastatic castration-sensitive prostate cancer. (ASCO-GU 2024)

Treatment intensification was defined as receiving one of the following within 90 days of initiation of ADT: apalutamide, enzalutamide, abiraterone +/- prednisone +/- docetaxel, darolutamide +/- docetaxel, docetaxel +/- other systemic therapy, and external beam radiation therapy (EBRT). Just over half of eligible patients received treatment intensification following ADT. There are also significant disparities in treatment by age, region, and site of metastases. Future studies examining physician and patient preferences for intensification, as well as possible misperceptions and biases, would provide evidence to address undertreatment in this setting.Note: Age and modified CCI score were not included within the same model due to multicollinearity.

5 months ago

Clinical • Metastases

docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide)

5ms

Overall survival with darolutamide vs placebo in combination with androgen-deprivation therapy (ADT) and docetaxel: A sensitivity analysis from ARASENS accounting for subsequent therapy. (ASCO-GU 2024)

The results of the post hoc and planned sensitivity analyses were consistent with and supportive of the ARASENS primary OS analysis. These data reinforce DARO + ADT + DOC as an effective and well tolerated new standard of care for early treatment intensification in pts with mHSPC. Clinical trial information: NCT02799602.

5 months ago

Clinical • Combination therapy

docetaxel • Nubeqa (darolutamide)