Clinical trials: Metastatic Hormone-sensitive Prostate Cancer
Prostate Cancer
A Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Prostate Cancer
This study will look at the effect of adding the drug Palbociclib to CAD (Combined Androgen Deprivation) therapy in patients with RB (Retinoblastoma Protein) positive hormone sensitive prostate cancer.
- Trial name
- NCT02059213
- Testing
- Ibrance, Bicalutamide, Zoladex
- Where
- 8 sites in United States
- Volunteers
- 72 people
- Sponsor
- University of Michigan Rogel Cancer Center
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
Castration-Sensitive Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8
Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM)
This phase II trial examines antiandrogen therapy interruptions in patients with hormone-sensitive prostate cancer that has spread to other places in the body (metastatic) responding exceptionally well to androgen…
- Trial name
- A-DREAM (NCT05241860)
- Testing
- Pharmacotherapy Discontinuation, Follow-Up, Questionnaire Administration
- Where
- 326 sites in United States
- Volunteers
- 79 people
- Sponsor
- Alliance for Clinical Trials in Oncology
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
Metastatic Prostate Cancer, Prostate Cancer Metastatic
Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide
This is a prospective, randomized, open-label phase II study comparing cognitive outcomes between men with metastatic and non-metastatic castration resistant prostate cancer (CRPC) or metastatic hormone sensitive prostate cancer…
- Conditions
- Metastatic Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer, Castrate Resistant Prostate Cancer
- Trial name
- ARACOG (NCT04335682)
- Testing
- Darolutamide, Enzalutamide
- Where
- 8 sites in United States
- Volunteers
- 111 people
- Sponsor
- Alliance Foundation Trials, LLC.
PSA Level Greater Than Two, Stage IV Prostate Adenocarcinoma AJCC v7
Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
This phase II trial studies how well hormone therapy and intensity-modulated radiation therapy work in treating patients with prostate cancer that has spread to other places in the body.
- Trial name
- NCT00544830
- Testing
- Bicalutamide, Goserelin Acetate, Intensity-Modulated Radiation Therapy
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- City of Hope Medical Center
Prostate Adenocarcinoma
Radium Ra 223 Dichloride, Hormone Therapy and Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
This phase 2 trial studies radium Ra 223 dichloride, hormone therapy and stereotactic body radiation in treating patients with prostate cancer that has spread to other places in the body.
- Trial name
- NCT03361735
- Testing
- Leuprolide Acetate, Goserelin Acetate, Stereotactic Body Radiation Therapy
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- City of Hope Medical Center
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
Prostate Cancer
A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC
The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.
- Trial name
- TITAN (NCT02489318)
- Testing
- Apalutamide, Androgen Deprivation Therapy (ADT)
- Where
- 220 sites in United States, Argentina and 20 more
- Volunteers
- 1,052 people
- Sponsor
- Aragon Pharmaceuticals, Inc.
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
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.
Metastatic Hormone Sensitive Prostate Cancer
A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
The purpose of this study was to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review.
- Trial name
- ARCHES (NCT02677896)
- Testing
- Enzalutamide
- Where
- 203 sites in United States, Argentina and 22 more
- Volunteers
- 1,150 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer
LHRH Analogue Therapy With Enzalutamide or Bicalutamide in Treating Patients With Hormone Sensitive Prostate Cancer
This randomized phase II trial studies if enzalutamide added to standard luteinizing hormone-releasing hormone (LHRH) analogue therapy will improve effects against prostate cancer compared to the standard therapy of LHRH analogue…
- Conditions
- Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer
- Trial name
- NCT02058706
- Testing
- enzalutamide, bicalutamide, orchiectomy
- Where
- 4 sites in United States
- Volunteers
- 71 people
- Sponsor
- Barbara Ann Karmanos Cancer Institute
Hormone Sensitive Prostate Cancer, Prostate Adenocarcinoma
Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors
This research study is studying a combination of hormonal therapy, chemotherapy, and immunotherapy as a possible treatment for metastatic hormone-sensitive prostate cancer.
- Conditions
- Hormone Sensitive Prostate Cancer, Prostate Adenocarcinoma, Metastasis Prostate Adenocarcinoma
- Trial name
- NCT04126070
- Testing
- Androgen Deprivation Therapy, Nivolumab, Docetaxel
- Where
- 6 sites in United States
- Volunteers
- 47 people
- Sponsor
- Xiao X. Wei, MD
Metastatic Castration-resistant Prostate Cancer, Metastatic Castration-sensitive Prostate Cancer
TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer
The purpose of this study is to investigate the safety and efficacy of a new formulation of an existing drug product called TAVT-45 in patients with metastatic prostate cancer.
- Conditions
- Metastatic Castration-resistant Prostate Cancer, Metastatic Castration-sensitive Prostate Cancer, Metastatic Prostate Cancer
- Trial name
- NCT04887506
- Testing
- TAVT-45, Zytiga, Prednisone
- Where
- 42 sites in United States, France and 6 more
- Volunteers
- 107 people
- Sponsor
- Tavanta Therapeutics
Prostate Cancer
Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer
Background: Enzalutamide is a well tolerated hormone therapy that is used to treat advanced prostate cancer. It is given to help kill cancer cells and limit cancer cell growth.
- Trial name
- NCT01875250
- Testing
- PROSTVAC-F (Fowlpox)/TRICOM, PROSTVAC-V (Vaccinia)/TRICOM, Enzalutamide (Xtandi)
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- National Cancer Institute (NCI)
Prostate Adenocarcinoma, Recurrent Prostate Carcinoma
Bicalutamide and Goserelin or Leuprolide Acetate With or Without Cixutumumab in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer
This randomized phase II trial is studying bicalutamide, goserelin, or leuprolide acetate to see how well they work when given with or without cixutumumab in treating patients with newly diagnosed metastatic prostate cancer.
- Conditions
- Prostate Adenocarcinoma, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer
- Trial name
- NCT01120236
- Testing
- Bicalutamide, Cixutumumab, Goserelin Acetate
- Where
- 170 sites in United States, Canada
- Volunteers
- 211 people
- Sponsor
- National Cancer Institute (NCI)
Prostate Cancer, Prostate Neoplasms
Docetaxel and PROSTVAC for Metastatic Castration-Sensitive Prostate Cancer
Background: Metastatic castrate-sensitive prostate cancer is cancer that has spread beyond the prostate area. It can be controlled by lowering the amount of testosterone in the body.
- Conditions
- Prostate Cancer, Prostate Neoplasms, Neoplasms, Prostatic
- Trial name
- NCT02649855
- Testing
- PROSTVAC-V, PROSTVAC-F, Docetaxel
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- National Cancer Institute (NCI)
Metastatic Castration Sensitive Prostate Cancer (mCSPC), Metastatic Castration Resistant Prostate Cancer (mCRPC)
Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland
Comprehensive understanding of the epidemiology and disease burden of metastatic prostate cancer patients in Finland is lacking.
- Trial name
- NCT05701007
- Testing
- abiraterone, enzalutamide, docetaxel
- Where
- Finland
- Volunteers
- 1,083 people
- Sponsor
- Pfizer