Clinical trials: Metastatic Castration-Sensitive Prostate Cancer
- Condition Metastatic Castration-Sensitive Prostate Cancer
- Funder type Industry (pharma, biotech, devices)
Metastatic Castrate-sensitive Prostate Cancer
A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level…
- Trial name
- LIBERTAS (NCT05884398)
- Testing
- Apalutamide, Androgen-deprivation Therapy (ADT)
- Where
- 93 sites in United States, Australia and 7 more
- Volunteers
- 420 people
- Sponsor
- Janssen Research & Development, LLC
Prostatic Neoplasms
A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
The purpose of this study is to learn about how long novel hormonal therapies are taken by men to treat mCSPC. Novel hormonal therapies in this study include study medicines abiraterone, apalutamide, and enzalutamide.
- Trial name
- NCT06072196
- Testing
- Novel hormonal therapy
- Where
- United States
- Volunteers
- 3,017 people
- Sponsor
- Pfizer
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)
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, Metastatic Castration-Resistant Prostate Cancer
A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer
Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer. It works by reducing the amount of the main male sex hormone, testosterone in the body.
- Conditions
- Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer, Metastatic Hormone Sensitive Prostate Cancer
- Trial name
- NCT07005154
- Testing
- ASP5541, Prednisone, Prednisolone
- Where
- 54 sites in United States, China and 10 more
- Volunteers
- 218 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer
This study aims to compare the efficacy and safety of rezvilutamide with enzalutamide in the treatment of patients with low-volume metastatic hormone sensitive prostate cancer.
- Trial name
- NCT07241416
- Testing
- Rezvilutamide Tablets, Enzalutamide Soft Capsules
- Where
- China
- Volunteers
- 206 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Healthy Volunteers (Intended Indication: Metastatic Patients With Triple Negative or HR+ Breast Cancer, or Hormone Sensitive Prostate Cancer)
A Study to Assess How Itraconazole Affects the Uptake and Elimination of Capivasertib in the Body
This study will be an open-label, fixed sequence study in healthy subjects (vasectomized males and females of non-childbearing potential), performed at a single study centre.
- Trial name
- NCT04712396
- Testing
- Capivasertib, Itraconazole
- Where
- Germany
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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
Prostate Cancer, Metastatic Castration Resistant Prostate Cancer
A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer
Medicines that reduce the amount of testosterone in the body are commonly used to treat prostate cancer. PRL-02 depot is a potential treatment for men with advanced prostate cancer. It is given by an injection into the muscle.
- Conditions
- Prostate Cancer, Metastatic Castration Resistant Prostate Cancer, Metastatic Castration-sensitive Prostate Cancer
- Trial name
- NCT04729114
- Testing
- PRL-02 injection, prednisone, dexamethasone
- Where
- 25 sites in United States, Puerto Rico
- Volunteers
- 174 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, Metastatic Hormone-sensitive Prostate Cancer
A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France
This study aims to explore the real-world treatment adherence, persistence of apalutamide, and assess the risk of non-adherence according to the participant's profile and behavior of metastatic hormone-sensitive prostate cancer…
- Trial name
- OBSAPA (NCT07451002)
- Where
- France
- Volunteers
- 540 people
- Sponsor
- Janssen Cilag S.A.S.
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, Metastatic Castration-resistant Prostate Cancer
[Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer
ACCEL is a multicenter, open label phase Ia/Ib/II study of [Ac-225]-PSMA-62 in participants with prostate-specific membrane antigen (PSMA)-positive prostate cancer.
- Conditions
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Oligometastatic Prostate Carcinoma, Hormone Sensitive Prostate Cancer
- Trial name
- ACCEL (NCT06229366)
- Testing
- [Ac-225]-PSMA-62 (mCRPC), [Ac-225]-PSMA-62 (OmHSPC)
- Where
- 7 sites in Canada
- Volunteers
- 142 people
- Sponsor
- Eli Lilly and Company
Prostate Cancer
Aggressive Disease Treatment Patterns and CtDNA HRR evaluatiON in High-volume metastatiC hORmone-sensitive Prostate Cancer in Russian FeDeration
A multicentre observational study on treatment patterns and ctDNA HRR evaluation in aggressive high-volume metastatic hormone-sensitive prostate cancer in Russian Federation
- Trial name
- CONCORD (NCT07052578)
- Where
- 28 sites in Russia
- Volunteers
- 230 people
- Sponsor
- AstraZeneca
Metastatic Hormone-sensitive Prostate Cancer
An Observational Study to Learn More About Treatment Patterns and Factors Determining the Choice of Treatment in Canadian Men With Metastatic Hormone Sensitive Prostate Cancer in Routine Medical Care
This is an observational study in which only data are collected from adult Canadian men with metastatic hormone sensitive prostate cancer (mHSPC) are studied.
- Trial name
- RE-ENGAGE (NCT06874114)
- Where
- Canada
- Volunteers
- 477 people
- Sponsor
- Bayer
Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate
RYZ711 Diagnostic Platform Study
This is a Phase 1/2 multicenter, multi-cohort imaging study to evaluate the safety, tolerability, and diagnostic performance of RYZ711 positron emission tomography/computed tomography (PET/CT) in men with histologically confirmed…
- Conditions
- Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate, Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Trial name
- NCT07862582
- Testing
- RYZ711, PSMA PET/CT
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- RayzeBio, Inc.
Metastatic Castration-Resistant Prostate Cancer, Metastatic Castration-Sensitive Prostate Cancer
Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer
This study is being conducted to assess the safety and tolerability of relugolix with other agents approved for use in combination with androgen deprivation therapy (ADT) for a 12-week treatment period and an additional 40-week…
- Conditions
- Metastatic Castration-Resistant Prostate Cancer, Metastatic Castration-Sensitive Prostate Cancer, Non-Metastatic Castration-Resistant Prostate Cancer
- Trial name
- NCT04666129
- Testing
- Relugolix, Abiraterone, Prednisone
- Where
- 16 sites in United States
- Volunteers
- 48 people
- Sponsor
- Sumitomo Pharma America, Inc.
Advanced Solid Tumors
A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1311/BNT324 in subjects with advanced solid tumors.
- Trial name
- NCT05914116
- Testing
- DB-1311, Lopinavir and Ritonavir Tablets, itraconazole
- Where
- 107 sites in United States, Australia and 2 more
- Volunteers
- 862 people
- Sponsor
- DualityBio Inc.
Prostatic Neoplasms
Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer
The purpose of the study is to assess the efficacy and safety of darolutamide in combination with standard androgen deprivation therapy (ADT) in patients with metastatic hormone sensitive prostate cancer.
- Trial name
- ARANOTE (NCT04736199)
- Testing
- Darolutamide (Nubeqa, BAY1841788), Androgen deprivation therapy (ADT)
- Where
- 131 sites in Australia, Brazil and 13 more
- Volunteers
- 669 people
- Sponsor
- Bayer
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