Clinical trials: Metastatic Hormone Sensitive Prostate Cancer
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
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
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 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
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 (Adenocarcinoma)
Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response
This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs? This study would like to find out if this approach…
- Trial name
- TRIPLE-SWITCH (NCT06592924)
- Testing
- Abiraterone, Enzalutamide, Apalutamide
- Where
- 395 sites in United States, Canada and 2 more
- Volunteers
- 830 people
- Sponsor
- Canadian Cancer Trials Group
Prostate Cancer
CASCARA: Castration Sensitive Carboplatin, Cabazitaxel and Abiraterone
This is a phase II clinical trial in patients with metastatic castration sensitive prostate cancer. The objective of the study is to determine the efficacy and further define the safety of the treatment combination.
- Trial name
- NCT03934840
- Testing
- Cabazitaxel, Carboplatin, Abiraterone
- Where
- 8 sites in United States
- Volunteers
- 61 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Prostate Cancer Metastatic, Radiotherapy Side Effect
Metastatic Prostate Cancer Men's Attitudes Towards Treatment of the Local Tumour and Metastasis Evaluative Research
Systemic therapy (i.e Androgen Deprivation Therapy with Docetaxel, Enzalutamide, Apalutamide or Abiraterone Acetate) has increased overall survival in men with hormone-sensitive metastatic prostate cancer.
- Conditions
- Prostate Cancer Metastatic, Radiotherapy Side Effect, Surgery, Urologic Cancer
- Trial name
- IP5-MATTER (NCT04590976)
- Testing
- Semi-Structured Interview Healthcare Professional, Semi-Structured Interview Patients, Think Aloud Interview Patients
- Where
- 35 sites in United Kingdom
- Volunteers
- 320 people
- Sponsor
- Imperial College London
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.
Prostate Cancer, Stage IV Prostate Cancer
First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer
The goal of this clinical research is to find if sequential therapy with combined androgen deprivation or hormonal therapy with luteinizing hormone release hormone (LHRH) analog plus a new hormonal agent (abiraterone…
- Trial name
- NCT05189457
- Testing
- Luteinizing Hormone Releasing Hormone, New Hormonal Agent, Docetaxel
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Adenocarcinoma
Vudalimab (XmAb20717) in Combination With Standard of Care Treatment in Patients With Metastatic Castration Sensitive Prostate Cancer
This phase I trial tests the safety and effectiveness of vudalimab (XmAb20717) in combination with standard of care treatment abiraterone, enzalutamide, or abiraterone plus docetaxel in treating patients with castration sensitive…
- Conditions
- Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
- Trial name
- NCT05733351
- Testing
- Abiraterone, Biospecimen Collection, Bone Scan
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Emory University