Clinical trials: Hormone Sensitive Prostate Cancer
Prostate Cancer, Castrate Sensitive Prostate Cancer
Focal Radiation With Pulsed Systemic Therapy of Abiraterone, Androgen Deprivation Therapy (ADT), Lynparza Towards Castration Sensitive Oligometastatic Prostate Cancer (FAALCON)
The purpose of this study is to assess the safety and effectiveness of radiation therapy with hormone therapy (ADT) and chemotherapy as an investigational study treatment for prostate cancer.
- Conditions
- Prostate Cancer, Castrate Sensitive Prostate Cancer, Oligometastatic Disease
- Trial name
- NCT04748042
- Testing
- Abiraterone, Prednisone, External Beam Radiotherapy
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Michigan Rogel Cancer Center
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 Castration-sensitive Prostate Cancer
A Study Called AWARENESS Using Data From Men in Alberta to Observe Treatment Patterns for Metastatic Castration-sensitive Prostate Cancer
This is an observational study in which patient data from the past on men with metastatic castration-sensitive prostate cancer is studied.
- Trial name
- NCT05149131
- Testing
- ADT (Eligard®*) with or without treatment intensification
- Where
- Canada
- Volunteers
- 960 people
- Sponsor
- Bayer
Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Adenocarcinoma
Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer
This phase II trial studies the effect of talazoparib with androgen deprivation therapy and abiraterone in treating castration sensitive prostate cancer patients.
- Conditions
- Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
- Trial name
- NCT04734730
- Testing
- Abiraterone Acetate, Bicalutamide, Degarelix
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- City of Hope Medical Center
Prostate Cancer
The Case of "Triple" Versus "Double" Therapy for Patients With High Volume Metastatic Hormone Sensitive Prostate Cancer
Lead4Care is an observational, open-label, multicenter study evaluating the effectiveness, tolerance, and cost-effectiveness of triple against double therapy in matched groups of mHSPC patients with high tumor burden.
- Trial name
- Lead4Care (NCT06446401)
- Testing
- ADT + NHT + Docetaxel, ADT + NHT
- Where
- 2 sites in Sweden
- Volunteers
- 1,400 people
- Sponsor
- Uppsala University
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
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.
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
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India
This study will follow patients with metastatic hormone-sensitive prostate cancer in India who receive darolutamide plus androgen deprivation therapy as part of routine medical care.
- Trial name
- PACE mHSPC (NCT07806591)
- Testing
- Darolutamide plus androgen deprivation therapy
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Bayer
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.
Prostatic Neoplasms
A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces
The purpose of this study is to learn about- for how long are NHTs taken by men to treat mCSPC. NHTs in this study include study medicines: abiraterone, apalutamide, enzalutamide.
- Trial name
- NCT06151418
- Testing
- Novel hormonal therapy
- Where
- United States
- Volunteers
- 2,313 people
- Sponsor
- Pfizer
Metastatic Prostate Cancer
INTense ExeRcise for SurviVAL Among Men with Metastatic Prostate Cancer (INTERVAL - GAP4)
To determine if supervised high intensity aerobic and resistance training increases overall survival compared to self-directed exercise in patients with metastatic prostate cancer.
- Trial name
- INTERVAL (NCT02730338)
- Testing
- High intensity aerobic and resistance training, Psychosocial support
- Where
- 18 sites in United States, Australia and 4 more
- Volunteers
- 866 people
- Sponsor
- Movember Foundation
Metastatic Castration Resistant Prostate Cancer
A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)
Himalayas-1 is a randomized, open-label, global, multicenter phase 3 study evaluating whether the combination of rinzimetostat with darolutamide is more effective compared to physician's choice of control; ARPI (darolutamide or…
- Trial name
- Himalayas-1 (NCT07723248)
- Testing
- Rinzimetostat, Darolutamide, Enzalutamide
- Where
- 12 sites in United States, Puerto Rico
- Volunteers
- 600 people
- Sponsor
- ORIC Pharmaceuticals
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
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 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.
Metastatic Hormone-Sensitive Prostate Cancer, Prostate Cancer
PSMA PET/CT-Based Multimodal Model for Predicting Response to First-Line Therapy in mHSPC.
This multicenter retrospective study developed and validated a prediction model based on PSMA PET/CT and routine clinical information to estimate early treatment response in patients with metastatic hormone-sensitive prostate…
- Trial name
- NCT07428642
- Testing
- Androgen Deprivation Therapy, Apalutamide, Enzalutamide
- Where
- China
- Volunteers
- 168 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University
Prostate Cancer, Stage IV Prostate Cancer
Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer
Adaptive Androgen Deprivation Therapy (ADT) plus Standard of Care. The purpose of this study is to develop adaptive therapy for high risk metastatic castration sensitive prostate cancer (mCSPC).
- Conditions
- Prostate Cancer, Stage IV Prostate Cancer, Advanced Prostate Cancer, Adenocarcinoma of the Prostate
- Trial name
- NCT03511196
- Testing
- Adaptive Androgen Deprivation Therapy (ADT), Abiraterone, Prednisone
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Prostate Adenocarcinoma, Castration Sensitive Prostate Cancer
Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC)
The goal of this study is to determine whether the addition of Androgen Deprivation Therapy (ADT) utilizing the study drug ELIGARD® to Recurrence- Directed Therapy (RDT) improves progression-free survival (PFS) compared to RDT…
- Trial name
- RATIONAL (NCT06654336)
- Testing
- Recurrence-directed therapy (RDT), ELIGARD 22.5mg
- Where
- 5 sites in Canada
- Volunteers
- 162 people
- Sponsor
- Ontario Clinical Oncology Group (OCOG)
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