BAY 1841788

A Phase 1/2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination with Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

SUrGery with or without dARolutamide in high-risk and/or locally advanced prostate cancer

Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER): A Two-part Phase 2/3 Trial

Stereotactic body radiotherapy with or without Darolutamide for OligoRecurrent prostate cancer: a randomized phase II trial (DART).

EORTC-1532-GUCG: A phase 2 Randomized Open-Label Study of Oral darolutamide (ODM-201) vs. androgen deprivation therapy (ADT) with LHRH agonists or antagonist in Men with Hormone Naive Prostate Cancer.

DARIUS : A RANDOMIZED NON-COMPARATIVE PHASE II MULTICENTRIC TRIAL ON SHORT TERM DAROLUTAMIDE (ODM-201) CONCOMITANT TO RADIATION THERAPY FOR PATIENTS WITH INTERMEDIATE UNFAVORABLE RISK PROSTATE CANCER

SAKK 08/23: Addition of Darolutamide to first line treatment of mCRPC: a randomized open label phase II trial

Darolutamide with Bipolar Androgen Therapy (BAT) for Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC) – the DaroBAT Trial

PEACE 6 Vulnerable : A double-blind randomised phase III trial evaluating the efficacy of ADT +/- darolutamide in de novo metastatic prostate cancer patients with vulnerable functional ability and not elected for docetaxel or androgen receptor targeted agents.

(21140 ARANOTE) A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide in addition to androgen deprivation therapy (ADT) versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC).

(20321) An open-label, single arm, roll-over study to provide continued treatment with darolutamide in participants who were enrolled in previous Bayer sponsored studies

(21492 ARASTEP) A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide plus androgen deprivation therapy (ADT) compared with placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer

A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination with Physician’s Choice New Hormonal Agents in Patients with HRRm and non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01).

PEACE 7 : A randomized Phase III trial with a factorial design evaluating the efficacy and safety of darolutamide and stereotactic dose escalated radiotherapy in patients with localized prostate cancer and high-risk features ofrelapse, from the Prostate Cancer Consortium in Europe (PEACE).

PEACE 8: Combination of darolutamide and stereotactic body radiation therapy in patients with castration resistant prostate cancer and oligometastases on functional imaging.

ProBio: An outcome-adaptive and randomised multi-arm biomarker driven study in patients with metastatic prostate cancer

DASL-HiCaP: Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801). A randomised phase 3 double-blind, placebo-controlled trial of adding darolutamide to androgen deprivation therapy and definitive or salvage radiation in very high risk, clinically localised prostate cancer.

ALADDIN: evaluation of dAroLutamide Addition to anDrogen Deprivation therapy and radIatioN therapy in newly diagnosed prostate cancer with pelvic lymph nodes metastases