Clinical trials: Hormone-Sensitive Prostate Cancer
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Multimodal Approach in Patients With mHSPC. Randomized Trial of APA+ADT vs APA-ADT and Local Treatment
Italian multicenter study, will enroll ~566 pts with oligometastatic hormone sensitive prostate cancer who are candidates to receive treatment with apalutamide.
- Trial name
- APPROACH (NCT05649943)
- Testing
- APA + ADT, Local Treatmetn RT or RP
- Where
- 3 sites in Italy
- Volunteers
- 566 people
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
A Study to Learn More About How Safe Darolutamide is Under Real-world Conditions in Participants With Metastatic Hormone-Sensitive Prostate Cancer
This is an observational study in which only data are collected from participants receiving their usual treatment. In this study, data will be collected and studied from men with metastatic hormone-sensitive prostate cancer…
- Trial name
- DADOX (NCT06010914)
- Testing
- No Intervention
- Where
- Japan
- Volunteers
- 100 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.
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer
Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer
This randomized phase II trial compares enzalutamide with standard androgen deprivation therapy in reducing incidence of metabolic syndrome in patients with prostate cancer that has spread to other places in the body.
- Conditions
- Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer
- Trial name
- NCT02278185
- Testing
- Enzalutamide, leuprolide acetate, goserelin acetate
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- University of Colorado, Denver
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients
The ADAPT study is an observational study of apalutamide, which can be given to patients with hormone sensitive metastatic prostate cancer as standard of care.
- Trial name
- ADAPT-P (NCT06019676)
- Where
- 12 sites in United Kingdom
- Volunteers
- 170 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Prostate Cancer
Lutetium-177-PSMA-617 in Oligo-metastatic Hormone Sensitive Prostate Cancer
Radioligand therapy (RLT) using Lutetium-177 labelled PSMA is a promising new therapeutic approach to treat metastatic prostate cancer.
- Trial name
- Bullseye (NCT04443062)
- Testing
- 177Lu-PSMA-617
- Where
- 4 sites in Cyprus, Netherlands
- Volunteers
- 58 people
- Sponsor
- Radboud University Medical Center
Prostate Cancer
Patient Preference of Apalutamide Versus Enzalutamide in Patients With Recurrent or Metastatic Hormone-Sensitive Prostate Cancer
This is a prospective, open-label, randomized, controlled, cross-over trial assessing patient preference for apalutamide versus enzalutamide in 146 male patients with recurrent or metastatic hormone-sensitive prostate cancer.
- Trial name
- NCT04409288
- Testing
- Apalutamide, Enzalutamide
- Where
- Hong Kong
- Volunteers
- 74 people
- Sponsor
- Chinese University of Hong Kong
Metastatic Prostate Cancer
Talazoparib Plus Enzalutamide After Progression to Prior ARPi in Metastatic Prostate Cancer
The purpose of this clinical trial is to determine the anti-tumor activity of talazoparib plus enzalutamide as first line treatment for metastatic castration resistant prostate cancer (mCRPC) in participants whose disease has…
- Trial name
- TEAM PC (NCT06582628)
- Testing
- Enzalutamide capsule, Enzalutamide capsule and Talazoparib capsule
- Where
- 19 sites in France, Spain
- Volunteers
- 78 people
- Sponsor
- Fundacion Oncosur
Prostate Cancer
Phase I/II Study of Hydroxychloroquine With Itraconazole With Biochemically Recurrent Prostate Cancer
Recent pre-clinical work has suggested that Itraconazole has an anti-cancer effect that works synergistically with hydroxychloroquine.
- Trial name
- HITMAN-PC (NCT03513211)
- Testing
- SUBA-itraconazole, Hydroxychloroquine
- Where
- Australia
- Volunteers
- 12 people
- Sponsor
- St Vincent's Hospital, Sydney
Oligometastatic Hormone Sensitive Prostate Cancer
APalutamiAPalutamide and stEReotactic Body Radiation Therapy for Metastatic Prostate Cancer
Final results from TITAN trial showed that apalutamide plus ADT improved OS in a population of patients with metastatic hormone sensitive prostate cancer (mHSPC), if compared to ADT alone.
- Trial name
- PERSIAN (NCT05717660)
- Testing
- SBRT on all sites of metastatic disease+Apalutamide
- Where
- Italy
- Volunteers
- 180 people
- Sponsor
- Azienda Ospedaliero-Universitaria Careggi
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
Cancer, Urology
Monitoring Treatment Response With Urine and Serum Metabolome Markers in Patients Treated With Novel Hormone Therapy and Have Either Hormone Sensitive Metastatic Prostate Cancer or Disease Progression on Treatment.
80% of patients with newly diagnosed metastatic hormone sensitive prostate cancer have bone metastases. There are mutations that are described with early disease progression when on hormone therapy for prostate cancer.
- Trial name
- Metabolome-PC (NCT07837063)
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- The Clatterbridge Cancer Centre NHS Foundation Trust
Castration Sensitive Prostate Cancer, Metastatic Prostate Cancer
A Study Testing if Patients With Advanced Prostate Cancer Who Are Responding Well to Combination Treatment Can Safely Reduce Their Medication to a Single Hormone Therapy, Compared to Continuing Their Current Drugs
The goal of this randomized comparative study (a study where participants are placed into groups by chance) is to find out if reducing treatment to androgen deprivation therapy (ADT)-a treatment that lowers testosterone-by itself…
- Trial name
- STEPDOWNmHSPC (NCT07838753)
- Testing
- De-escalation strategy, Continuation of initial Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitor (ARPI) combination therapy at standard doses
- Where
- India
- Volunteers
- 170 people
- Sponsor
- Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
Hormone Sensitive Prostate Cancer, Prostate Cancer
Cardiovascular Events in GnRH Agonist vs. Antagonist
The purpose of this study is to test if the use of Degarelix for 1 year associated with a lower rate of cardiovascular toxicity compared to Gonadotropin-releasing hormone (GnRH) agonists in patients with advanced prostate cancer…
- Conditions
- Hormone Sensitive Prostate Cancer, Prostate Cancer, Cardiac Event
- Trial name
- NCT04182594
- Testing
- Degarelix, GnRH agonist
- Where
- Israel
- Volunteers
- 80 people
- Sponsor
- Rabin Medical Center
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)
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
Prostate Cancer, Hormone-Dependent Prostate Cancer
A Study of SHR3680 in Treating Patients With Hormone Sensitive Prostate Cancer
The aim of this study is to compare the safety and efficacy of SHR3680 with bicalutamide in the treatment of patients with hormone sensitive prostate cancer.
- Trial name
- NCT03520478
- Testing
- SHR3680, Bicalutamide
- Where
- 67 sites in Bulgaria, China and 2 more
- Volunteers
- 654 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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
PSMA Response in Metastasized Hormone Sensitive Prostate Cancer
PSMA-PET/CT response measurements after LHRH agonist and upfront therapy in men diagnosed with de novo metastasized hormonal sensitive prostate cancer.
- Trial name
- PET-MaN (NCT05161728)
- Testing
- PSMA-PET/CT
- Where
- 4 sites in Netherlands
- Volunteers
- 150 people
- Sponsor
- Roderick van den Bergh
Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer
A Study to Evaluate the Safety and Drug Levels of ASP5541 in Chinese Participants With Prostate Cancer
In this study, ASP5541 will be given to Chinese men with prostate cancer. It will be given together with prednisone and androgen deprivation therapy (ADT).
- Conditions
- Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer, Metastatic Hormone Sensitive Prostate Cancer
- Trial name
- NCT07339267
- Testing
- ASP5541, Prednisone
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Astellas Pharma Global Development, Inc.