Clinical trials: Metastatic Hormone-sensitive Prostate Cancer
Metastatic Castration Sensitive Prostate Cancer (mCSPC)
A Study to Learn About the Outcomes Between Study Medicines, Enzalutamide and Darolutamide Among Men With Metastatic Castration Sensitive Prostate Cancer (mCSPC)
The purpose of this real-world study of electronic medical records is to look back to compare the time to next treatment after initial treatment with enzalutamide or darolutamide in addition to androgen deprivation therapy (ADT).
- Trial name
- NCT07779590
- Testing
- darolutamide plus androgen deprivation therapy, Enzalutamide plus androgen deprivation therapy
- Where
- United States
- Volunteers
- 4,700 people
- Sponsor
- Pfizer
Prostate Cancer, Bone Metastases
Luteinizing Hormone-releasing Hormone Analogue and Enzalutamide +/- Zoledronic Acid in Prostate Cancer Patients
This study was undertaken to evaluate bone response in metastatic prostate cancer patients treated with Enzalutamide with or without Zoledronic Acid in combination with luteinizing hormone-releasing hormone (LHRH) analogue with…
- Trial name
- BonEnza (NCT03336983)
- Testing
- Zoledronic Acid, Enzalutamide
- Where
- Italy
- Volunteers
- 126 people
- Sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Prostate Adenocarcinoma
Exploration of the Value of PSMA PET/CT in Dynamic Monitoring of the Efficacy of Novel Endocrine Therapy in Patients With Metastatic Hormone Sensitive Prostate Cancer
1. Based on the treatment response and prognosis of mHSPC patients with novel endocrine therapy, a PSMA PET whole-body tumor burden classification was constructed to guide treatment and evaluate prognosis. 2.
- Trial name
- NCT06387238
- Testing
- PSMA PET/CT
- Volunteers
- 150 people
- Sponsor
- Peking University First Hospital
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
Castration-Sensitive Prostate Adenocarcinoma, Metastatic Castration-Sensitive Prostate Adenocarcinoma
Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Cancer, EQUIP Trial
This phase II trial compares giving estrogen with an androgen receptor signaling inhibitor to standard of care luteinizing hormone-releasing hormone (LHRH) analogues with an androgen receptor signaling inhibitor for improving…
- Conditions
- Castration-Sensitive Prostate Adenocarcinoma, Metastatic Castration-Sensitive Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
- Trial name
- NCT07466498
- Testing
- Androgen Receptor Pathway Inhibitor, Transdermal Estrogen, Bone Scan
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Fred Hutchinson Cancer Center
Metastatic Prostate Cancer, Prostate Cancer (Adenocarcinoma)
CONVERT-HB1: Radical Prostatectomy After Systemic Therapy for High-volume Metastatic Hormone-sensitive Prostate Cancer
This is a prospective, randomized, open-label, phase II multicenter clinical trial evaluating the efficacy and safety of radical prostatectomy in patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC) who…
- Conditions
- Metastatic Prostate Cancer, Prostate Cancer (Adenocarcinoma), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Trial name
- CONVERT-HB1 (NCT07268794)
- Testing
- Androgen Deprivation Therapy (ADT), Docetaxel, PARP Inhibitors and Other Systemic Agents
- Where
- China
- Volunteers
- 112 people
- Sponsor
- Fudan University
Recurrent Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial
This phase II trial tests leuprolide acetate alone versus in combination with 177Lu-PSMA-617, with or without abiraterone acetate and prednisone, for the treatment of hormone-sensitive prostate cancer has spread to a limited…
- Conditions
- Recurrent Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8, Castration-Sensitive Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
- Trial name
- SPARKLE (NCT07650240)
- Testing
- Abiraterone Acetate, Biospecimen Collection, Leuprolide Acetate
- Where
- United States
- Volunteers
- 202 people
- Sponsor
- Mayo Clinic
Prostate Cancer, Biochemical Recurrence of Malignant Neoplasm of Prostate
PROCARE - PROstate Cancer Real World Evidence Registry
The aim of this registry study with long-term follow-up is to record the course of therapy and disease in patients with recurrent and metastatic prostate cancer.
- Conditions
- Prostate Cancer, Biochemical Recurrence of Malignant Neoplasm of Prostate, Non-metastatic Castration-resistant Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
- Trial name
- PROCARE (NCT06835218)
- Where
- 53 sites in Germany
- Volunteers
- 5,000 people
- Sponsor
- UroTrials Company (GmbH)
Prostate Cancer (Adenocarcinoma)
ProA Study: ProActive Management Model in Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated by Apalutamide
This is a Phase 4, multi-center, single arm, open-label clinical study to evaluate whether participants with mHSPC treated with apalutamide will benefit from the 4A ProActive Management Model.
- Trial name
- ProA (NCT06865547)
- Testing
- The 4A ProActive Management Model
- Where
- China
- Volunteers
- 94 people
- Sponsor
- Yonghong Li
Prostate Cancer, Prostate Cancer Recurrent
Metastasis-directed Therapy for Oligorecurrent Prostate Cancer
The aim is to investigate whether the addition of short-term androgen deprivation therapy (ADT) during 1 month or short-term ADT during 6 months together with an androgen receptor targeted therapy (ARTA) to metastasis-directed…
- Conditions
- Prostate Cancer, Prostate Cancer Recurrent, Prostate Cancer Metastatic, Metastatic Cancer
- Trial name
- SPARKLE (NCT05352178)
- Testing
- Radiotherapy (SBRT) and/or surgery (metastasectomy), Androgen deprivation therapy, Androgen receptor targeted therapy
- Where
- Belgium
- Volunteers
- 873 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
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 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)
Metastatic Castration Sensitive Prostate Cancer
Combining Ipilimumab, Degarelix, and Radical Prostatectomy in Men With Newly Diagnosed Metastatic Castration Sensitive Prostate Cancer or Ipilimumab and Degarelix in Men With Biochemically Recurrent Castration Sensitive Prostate Cancer After Radical Prostatectomy
The purpose of this study is to find out what effects, good and/or bad, taking ipilimumab with degarelix before surgery to remove the prostate, followed by more degarelix and ipilimumab after the surgery, will have on prostate…
- Trial name
- NCT02020070
- Testing
- Degarelix, Ipilimumab, Radical Prostatectomy
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Prostate Cancer Metastatic
ACTInium-J591 Radionuclide Therapy in PSMA-Detected Metastatic HOrmone-Sensitive Recurrent Prostate CaNcer
The purpose of this study is to evaluate the safety of combining Actinium- J591 with radiation therapy or with androgen deprivation therapy.
- Trial name
- ACTION (NCT05567770)
- Testing
- Actinium-J591, Stereotactic Body Radiation Therapy, Androgen Deprivation Therapy
- Sponsor
- Weill Medical College of Cornell University
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.
Metastatic Prostate Cancer
Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
Assessment of the safety and efficacy of HLD-0915 (JNJ-101556143) in patients with metastatic prostate cancer who have progressed on prior systemic therapies, with further evaluation in additional prostate cancer populations.
- Trial name
- NCT06800313
- Testing
- JNJ-101556143 Formulation 1, JNJ-101556143 Formulation 2, JNJ-101556143 Formulation 3
- Where
- 18 sites in United States, United Kingdom
- Volunteers
- 190 people
- Sponsor
- Janssen Research & Development, LLC
Metastatic Prostate Cancer, Castration-Sensitive Prostate Cancer
Maximal Cytoreductive Therapies on Post-treatment Metastases in Pts With mHSPC During Apalutamide Plus ADT Treatment
To assess the feasibility and safety of Maximal cytoreductive therapies in patients with de novo mCSPC who achieve ≤10 oligopersistent metastases on PSMA PET CT after initial 3-month systemic treatment with apalutamide plus ADT.
- Trial name
- CHAMPION (NCT05717582)
- Testing
- apalutamide, androgen deprivation therapy, cytoreductive radical prostatectomy with/without pelvic lymph node dissection
- Where
- 2 sites in China
- Volunteers
- 47 people
- Sponsor
- Fudan University
Non-metastatic Castration-resistant Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer
An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea
This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive…
- Trial name
- NCT06334120
- Testing
- Darolutamide (Nubeqa, BAY1841788)
- Where
- South Korea
- Volunteers
- 600 people
- Sponsor
- Bayer
Prostate Cancer
A Study of Dovitinib With Androgen Deprivation Therapy (ADT) in Patients With Metastatic Prostate Cancer Receiving Primary ADT
This study will evaluate if adding the investigational drug Dovitinib to standard androgen ablation therapy (ADT) is beneficial in prolonging the time to disease progression in patients with metastatic prostate cancer who are…
- Trial name
- NCT02065323
- Testing
- Standard ADT, Dovitinib
- Where
- United States
- Sponsor
- Oscar Goodman, Jr.
Prostate Cancer
Study on Triple Therapy Combined With HIFU for High-Tumor-Burden mHSPC
This study is a single-arm prospective cohort study designed to evaluate the efficacy and safety of triple therapy (ADT + darolutamide + docetaxel) combined with transrectal high-intensity focused ultrasound (HIFU) focal therapy…
- Trial name
- NCT07172685
- Testing
- Darolutamide , Docetaxel , ADT and Transrectal HIFU Focal Therapy
- Where
- China
- Volunteers
- 116 people
- Sponsor
- Qilu Hospital of Shandong University