Enzalutamide

Generic Name: Enzalutamide

Brand Names: Xtandi, Enzalutamide Viatris

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₁₆F_₄N_₄O_₂S

CAS Number: 915087-33-1

Unique Ingredient Identifier: 93T0T9GKNU

Background: Enzalutamide is an androgen receptor (AR) inhibitor for the treatment of castration-resistant prostate cancer (CRPC), both metastatic and non-metastatic. It is a second-generation antiandrogen agent that the FDA approved on August 31, 2012. Although androgen deprivation therapy (ADT) is the first-line treatment of prostate cancer and remission can be achieve...

Indication: Enzalutamide is indicated for the treatment of castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer (mCRPC). It is also used in combination with talazoparib for the treatment of adult patients with HRR gene-mutated mCRPC.

Associated Conditions: Castration Resistant Prostate Cancer, Metastatic Castration Sensitive Prostate Cancer (mCSPC), Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Associated Therapies: -

Clinical Trials

Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial

Phase 2

Recruiting

Conditions: Prostate Adenocarcinoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Enzalutamide
Other: Fluorine F 18 Piflufolastat
Radiation: Image Guided Radiation Therapy
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
Other: Questionnaire Administration
Drug: Relugolix

First Posted Date: 2024-07-15

Last Posted Date: 2024-10-09

Lead Sponsor: Northwestern University

Target Recruit Count: 50

Registration Number: NCT06499870

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States

Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study

Not yet recruiting

Conditions: Prostate Cancer Metastatic to Bone
Prostate Cancer Metastatic
Oligometastatic Disease
Oligometastasis
Prostate Cancer
Prostate Neoplasm

First Posted Date: 2024-05-28

Last Posted Date: 2024-05-28

Lead Sponsor: Medical University of Vienna

Target Recruit Count: 500

Registration Number: NCT06430411

Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial

First Posted Date: 2024-04-23

Last Posted Date: 2024-11-26

Lead Sponsor: Mayo Clinic

Target Recruit Count: 120

Registration Number: NCT06378866

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Advanced Solid Tumor

Interventions: Drug: HS-20093
Drug: Adebrelimab
Drug: Cetuximab
Drug: Enzalutamide
Drug: Cisplatin/ Carboplatin

First Posted Date: 2024-03-27

Last Posted Date: 2024-07-18

Lead Sponsor: Hansoh BioMedical R&D Company

Target Recruit Count: 610

Registration Number: NCT06332170

Locations: 🇨🇳
Shanghai Chest Hospital, Shanghai, Shanghai, China

Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer

Phase 2

Active, not recruiting

Conditions: Prostate Cancer
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Prostate Adenocarcinoma

Interventions: Drug: EPI-7386
Drug: Enzalutamide
Drug: Androgen Deprivation Therapy (ADT)

First Posted Date: 2024-03-15

Last Posted Date: 2024-11-15

Lead Sponsor: Pedro Barata, MD, MSc

Target Recruit Count: 13

Registration Number: NCT06312670

Locations: 🇺🇸
University Hospitals Cleveland Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
🇺🇸
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Enzalutamide Implants (Enolen) in Patients With Prostate Cancer

Phase 1

Recruiting

Conditions: Prostate Adenocarcinoma

Interventions: Drug: enzalutamide

First Posted Date: 2024-02-14

Last Posted Date: 2024-06-28

Lead Sponsor: Alessa Therapeutics Inc.

Target Recruit Count: 20

Registration Number: NCT06257693

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer

Phase 1

Recruiting

Conditions: Castration-Resistant Prostate Carcinoma
Metastatic Prostate Adenocarcinoma
Stage IVB Prostate Cancer AJCC v8

Interventions: Biological: Anti-STEAP1 CAR T-cells
Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Bone Scan
Procedure: Computed Tomography
Drug: Cyclophosphamide
Procedure: Echocardiography
Drug: Enzalutamide
Drug: Fludarabine
Procedure: Leukapheresis
Procedure: Magnetic Resonance Imaging
Procedure: Multigated Acquisition Scan
Procedure: Positron Emission Tomography

First Posted Date: 2024-02-01

Last Posted Date: 2024-12-10

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 48

Registration Number: NCT06236139

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Study of SX-682 Plus Enzalutamide in Men with Abiraterone-Resistant Metastatic Castration Resistant Prostate Cancer

Phase 2

Recruiting

Conditions: Metastatic Castration-resistant Prostate Cancer

Interventions: Drug: SX-682
Drug: Enzalutamide

First Posted Date: 2024-01-29

Last Posted Date: 2024-11-25

Lead Sponsor: Syntrix Biosystems, Inc.

Target Recruit Count: 53

Registration Number: NCT06228053

Locations: 🇺🇸
University of California, Los Angeles, Los Angeles, California, United States
🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸
University of Michigan, Ann Arbor, Michigan, United States

and more 3 locations

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

Completed

Conditions: Non-metastatic Castration-resistant Prostate Cancer
Non-metastatic Prostate Cancer

Interventions: Drug: Darolutamide (Nubeqa, BAY1841788)
Drug: Apalutamide
Drug: Enzalutamide

First Posted Date: 2024-01-12

Last Posted Date: 2024-04-09

Lead Sponsor: Bayer

Target Recruit Count: 1800

Registration Number: NCT06204302

Locations: 🇺🇸
Bayer, Whippany, New Jersey, United States

Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)

Phase 3

Recruiting

Conditions: Prostate Cancer Metastatic

Interventions: Drug: Opevesostat
Drug: Abiraterone acetate
Drug: Hydrocortisone
Drug: Enzalutamide
Drug: Fludrocortisone acetate
Drug: Prednisone
Drug: Dexamethasone

First Posted Date: 2023-11-18

Last Posted Date: 2024-12-09

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1200

Registration Number: NCT06136624

Locations: 🇺🇸
Stanford Cancer Center ( Site 0036), Palo Alto, California, United States
🇳🇱
Amsterdam UMC, locatie VUmc ( Site 1156), Amsterdam, Noord-Holland, Netherlands
🇵🇱
Zachodniopomorskie Centrum Onkologii ( Site 1311), Szczecin, Zachodniopomorskie, Poland

and more 242 locations

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