Clinical trials: Hormone Sensitive Prostate Cancer
Metastatic Hormone Sensitive Prostate Cancer
An Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
The purpose of this study was to evaluate the efficacy and safety of enzalutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT in Chinese subjects with metastatic hormone sensitive prostate cancer (mHSPC).
- Trial name
- China ARCHES (NCT04076059)
- Testing
- Enzalutamide, Androgen deprivation therapy (ADT)
- Where
- 28 sites in China
- Volunteers
- 180 people
- Sponsor
- Astellas (Beijing) Pharmaceutical R&D Co., Ltd.
Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer
Survey Based Discrete Choice Experiment Study in Prostate Cancer (DECIDER) Study
The purpose of this study is to quantify and publish participants' relative preferences for outcomes of chemotherapy and novel oral hormonal agents when added to androgen deprivation therapy (ADT) for participants with…
- Trial name
- NCT05381311
- Where
- United States
- Volunteers
- 1,020 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer
The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.
- Trial name
- NCT07140900
- Testing
- Xaluritamig, Darolutamide, Abiraterone
- Where
- 16 sites in United States, Australia and 1 more
- Volunteers
- 60 people
- Sponsor
- Amgen
Prostate Cancer
Zoledronic Acid in the Prevention of Skeletal-related Events in Hormone Refractory and Hormone-sensitive Prostate Cancer Patients With Bone Metastases
The present study will give information about the course over time in skeletal-related events (SRE) in prostate cancer patients with bone metastases treated with zoledronic acid 4 mg administered as a 15-minute infusion every 4…
- Trial name
- NCT00219219
- Testing
- Zoledronic acid
- Where
- Italy
- Sponsor
- Novartis
Metastatic Castration Sensitive Prostate Cancer (mCSPC), Cancer of the Prostate
A Study to Learn About Two Medicines (Apalutamide and Enzalutamide) in People With Metastatic Castration-sensitive Prostate Cancer (mCSPC)
The purpose of this study is to learn about how long apalutamide and enzalutamide are taken by men to treat mCSPC. Prostate cancer is one of the most common cancers in men.
- Conditions
- Metastatic Castration Sensitive Prostate Cancer (mCSPC), Cancer of the Prostate, Prostate Neoplasms, Prostate Cancer
- Trial name
- NCT07086651
- Testing
- Enzalutamide, Apalutamide
- Where
- United States
- Volunteers
- 1,300 people
- Sponsor
- Pfizer
Metastatic Castration Sensitive Prostate Cancer (mCSPC), Hormone Sensitive Prostate Cancer
This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.
This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet…
- Conditions
- Metastatic Castration Sensitive Prostate Cancer (mCSPC), Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate
- Trial name
- NCT07028853
- Testing
- Mevrometostat, Enzalutamide
- Where
- 319 sites in United States, Argentina and 24 more
- Volunteers
- 1,000 people
- Sponsor
- Pfizer
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
The purpose of this study is to evaluate the safety, tolerability, and efficacy of two different treatment combinations of tulmimetostat in participants with de novo or recurrent metastatic hormone-sensitive prostate cancer…
- Trial name
- TulmiSTAR-02 (NCT07190300)
- Testing
- Tulmimetostat, Darolutamide, Abiraterone
- Where
- 31 sites in United States, Australia and 12 more
- Volunteers
- 181 people
- Sponsor
- Novartis Pharmaceuticals
Prostate Cancer
Observational Study of Docetaxel Exposure in Metastatic Prostate Cancer Patients
In this observational study, blood samples for pharmacokinetic (PK) testing will be collected from subjects with metastatic prostate cancer during their treatment with docetaxel.
- Trial name
- NCT02376296
- Testing
- docetaxel, Blood draws
- Where
- 20 sites in United States
- Volunteers
- 35 people
- Sponsor
- Saladax Biomedical, Inc.
Metastatic Hormone-sensitive Prostate Cancer
Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive…
- Trial name
- ARASENS (NCT02799602)
- Testing
- BAY1841788 / darolutamide (ODM-201), Standard ADT (androgen deprivation therapy), Docetaxel
- Where
- 322 sites in United States, Australia and 21 more
- Volunteers
- 1,306 people
- Sponsor
- Bayer
Hormone-Sensitive Prostate Cancer
Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency
This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in…
- Trial name
- CAPItello-281 (NCT04493853)
- Testing
- Capivasertib, Abiraterone Acetate
- Where
- 323 sites in United States, Argentina and 30 more
- Volunteers
- 1,012 people
- Sponsor
- AstraZeneca
Metastatic Hormone-sensitive Prostate Cancer
A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide
The purpose of this study is to assess the real-world outcomes differences between apalutamide or enzalutamide plus androgen deprivation therapy (ADT) for the treatment of participants with metastatic hormone-sensitive prostate…
- Trial name
- ArtemisPRO (NCT05901649)
- Testing
- Apalutamide, Enzalutamide
- Where
- 53 sites in Austria, France and 4 more
- Volunteers
- 505 people
- Sponsor
- Janssen-Cilag Ltd.
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany
Prostate cancer is a disease where cells in the prostate gland grow out of control. When prostate cancer has spread to other parts of the body but still responds to hormone treatment, it is called metastatic hormone-sensitive…
- Trial name
- 23146 (NCT07395804)
- Testing
- darolutamide plus ADT treatment
- Where
- Germany
- Volunteers
- 500 people
- Sponsor
- Bayer
Prostate Cancer
Efficacy and Safety Study of QLG1080 in Patients With Hormone-sensitive Advanced Prostate Cancer
The purpose of this study was to evaluate the efficacy and safety of QLG1080 in patients with hormone-sensitive advanced prostate cancer.
- Trial name
- NCT06837896
- Testing
- QLG1080
- Where
- China
- Volunteers
- 111 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Hormone-refractory Prostate Cancer
Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
There are many treatment options for men with various stages of prostate cancer. Some treatments work well for a while but can cause medical problems in some men. Also, the cancer may come back after treatment.
- Trial name
- NCT05997615
- Testing
- VIR-5500, Androgen receptor signaling inhibitor (ARSI), Docetaxel
- Where
- 26 sites in United States, Australia and 2 more
- Volunteers
- 347 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Prostate Cancer
Treatment Approaches and Biomarkers PRevalence In de Novo MEtastatic Hormone-sensitive Prostate Cancer in Russian Federation
A multicentre observational study on treatment approaches and biomarkers in de novo metastatic hormone sensitive prostate cancer in Russian Federation
- Trial name
- PRIME (NCT07146113)
- Where
- 16 sites in Russia
- Volunteers
- 400 people
- Sponsor
- AstraZeneca
Prostatic Neoplasms
A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer
The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate specific membrane…
- Trial name
- PRIMORDIUM (NCT04557059)
- Testing
- Radiotherapy, LHRHa, Apalutamide
- Where
- 141 sites in United States, Australia and 19 more
- Volunteers
- 691 people
- Sponsor
- Janssen Pharmaceutica N.V., Belgium
Metastatic Hormone-Sensitive Prostate Cancer
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)-China Extension
This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus Androgen Deprivation Therapy (ADT) versus placebo plus enzalutamide plus ADT in Chinese participants with mHSPC.
- Trial name
- NCT04934722
- Testing
- Pembrolizumab, Enzalutamide, Androgen Deprivation Therapy (ADT)
- Where
- 24 sites in China
- Volunteers
- 186 people
- Sponsor
- Merck Sharp & Dohme LLC
Metastatic Hormone-Sensitive Prostate Cancer
Non-Interventional Study to Establish Consensus on Management of Metastatic Hormone-Sensitive Prostate Cancer Patients
The purpose of this study is to establish an expert consensus recommendations on managing patients with mHSPC in South Korea, and to provide clinicians with a comprehensive guide to support their clinical decision making.
- Trial name
- NCT06452212
- Testing
- No Intervention
- Where
- South Korea
- Volunteers
- 23 people
- Sponsor
- Astellas Pharma Korea, Inc.
Metastatic Hormone-sensitive Prostate Cancer
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.
The purpose of the study is to assess if the addition of darolutamide to ADT compared with ADT alone would result in superior clinical efficacy in participants with metastatic hormone-sensitive prostate cancer (mHSPC) by…
- Trial name
- ARASEC (NCT05059236)
- Testing
- Darolutamide (BAY1841788, Nubeqa), ADT
- Where
- 31 sites in United States
- Volunteers
- 223 people
- Sponsor
- Bayer
Hormone Sensitive Prostate Cancer, Prostate Cancer
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both.
- Conditions
- Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate
- Trial name
- NCT02319837
- Testing
- Enzalutamide, Leuprolide Open Label
- Where
- 255 sites in United States, Australia and 15 more
- Volunteers
- 1,068 people
- Sponsor
- Pfizer