Clinical trials: mHSPC
Metastatic Prostate Cancer
AI-Assisted Patient Support in mHSPC
The purpose of this multicenter, open-label, randomized controlled trial is to evaluate whether patient-centered support delivered through a large language model (LLM)-based artificial intelligence (AI) agent reduces anxiety in…
- Trial name
- LUMINOUS (NCT07804030)
- Testing
- The Same Platform without AI Agent, AI Agent-Assisted Patient-Centered Support, Delayed AI Agent-Assisted Patient-Centered Support
- Where
- 4 sites in China
- Volunteers
- 160 people
- Sponsor
- Fudan University
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 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
Prostatic Neoplasms, Metastatic Hormone-Sensitive Prostate Cancer
A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics
Prostate cancer is the most common non-skin cancer among men in the United States. For some men, the cancer has already spread to other parts of the body at the time of diagnosis; this is called metastatic hormone-sensitive…
- Trial name
- Double-DARE (NCT07406282)
- Testing
- Darolutamide, Abiraterone acetate, Enzalutamide
- Where
- United States
- Volunteers
- 1,400 people
- Sponsor
- Bayer
Metastatic Hormone-Sensitive Prostate Cancer
Toxicity & Pharmacokinetics of 2 & 3-weekly Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
This study is designed to investigate the toxicity and pharmacokinetics (PK) of 2-weekly and 3-weekly docetaxel in metastatic hormone-sensitive prostate cancer (mHSPC).
- Trial name
- NCT03343977
- Testing
- docetaxel 50mg/m2, docetaxel 75mg/m2
- Where
- United States
- Sponsor
- Peng Wang, MD PhD
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
mHSPC, mHNPC
Safety and Efficacy Evaluation of LC-K76 in Patients With Metastatic Hormone-Sensitive Prostate Cancer
This study is a single-centre, randomised, paired 24-week intervention dosing trial. Its purpose is to evaluate the safety profile and efficacy of the investigational drug in subjects with metastatic hormone-sensitive prostate…
- Conditions
- mHSPC, mHNPC, Prostate Cancer Adenocarcinoma
- Trial name
- NCT07389174
- Testing
- Standard Endocrine Therapy, LC-K76
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Shanghai Changzheng Hospital
Metastatic Prostate Cancer, Hormone Sensitive Prostate Cancer
Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC
Evaluate whether the combination of Rezvilutamide and androgen deprivation therapy (ADT) with docetaxel improves overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to the…
- Conditions
- Metastatic Prostate Cancer, Hormone Sensitive Prostate Cancer, Chemotherapy Effect
- Trial name
- NCT05983783
- Testing
- Docetaxel, Rezvilutamide
- Where
- China
- Volunteers
- 200 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Deleterious HRR Gene Mutation
Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations
This is an open label, phase II trial in subjects with treatment naïve, metastatic hormone sensitive prostate cancer (mHSPC) with deleterious homologous recombination repair (HRR) alteration(s).
- Conditions
- Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Deleterious HRR Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation
- Trial name
- HARMONY (NCT06392841)
- Testing
- Androgen Deprivation Therapy (ADT), Niraparib/Abiraterone Acetate DAT, Abiraterone Acetate
- Sponsor
- Qian Qin
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 (mHSPC)
PSMA PET/CT-Guided SBRT Plus Darolutamide in mHSPC
This is a multicenter, randomized, open-label phase 2 study for men with metastatic hormone-sensitive prostate cancer. About 254 participants will first receive 6 months of darolutamide plus androgen deprivation therapy.
- Trial name
- PSMA-DaroRT (NCT07649421)
- Testing
- Stereotactic Body Radiotherapy (SBRT), Darolutamide 600 mg twice daily, Androgen Deprivation Therapy (ADT)
- Where
- China
- Volunteers
- 254 people
- Sponsor
- West China Hospital
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.
Prostate Cancer, Prostate Cancer Metastatic Disease
Patients With Metastasized Prostate Cancer Whose Prostate-specific Antigen-level (PSA) Remains >0,2 ng/ml After Six Months of Dual Antihormonal Therapy Will Receive Radiotherapy to the Prostate and Radiotherapy to Refractory Metastases
The goal of this clinical trial is to learn if radiotherapy to the prostate and PET-positive (positron emission tomography) metastasis will lead to radiological response on PSMA-PET (prostate specific membrane antigen-PET).
- Conditions
- Prostate Cancer, Prostate Cancer Metastatic Disease, Prostate Cancer Metastatic to Bone
- Trial name
- RIALTO (NCT07644754)
- Testing
- Radiotherapy to the prostate and to PSMA-PET positive metastases
- Volunteers
- 27 people
- Sponsor
- University Hospital Tuebingen
Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate
RYZ711 Diagnostic Platform Study
This is a Phase 1/2 multicenter, multi-cohort imaging study to evaluate the safety, tolerability, and diagnostic performance of RYZ711 positron emission tomography/computed tomography (PET/CT) in men with histologically confirmed…
- Conditions
- Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate, Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Trial name
- NCT07862582
- Testing
- RYZ711, PSMA PET/CT
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- RayzeBio, Inc.
Metastatic Hormone-sensitive Prostate Cancer
An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
This Phase II study aims to evaluate efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg once a day (QD) doses + abiraterone compared with an androgen receptor pathway inhibitor…
- Trial name
- NCT06991556
- Testing
- JSB462, Abiraterone, Enzalutamide
- Where
- 65 sites in United States, Australia and 13 more
- Volunteers
- 168 people
- Sponsor
- Novartis Pharmaceuticals
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
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
mHSPC
Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC
This is a single-arm, prospective, multicenter, interventional study, aimed at exploring the efficacy and safety of darolutamide + ADT combined with low-dose docetaxel in treating patients with mHSPC planning to recruit…
- Trial name
- LoDARO (NCT07503379)
- Testing
- Darolutamide + ADT Combined with Low-dose Docetaxel
- Where
- 3 sites in China
- Volunteers
- 109 people
- Sponsor
- Yonghong Li
PSMA Positive Tumors or Tumor Tissues, Prostate Cancer Metastatic
PSMA PET for Treatment Response evaLuation of systemIC Therapies in prostAte caNcer (PELICAN)
This prospective clinical study aims to evaluate the predictive power of PSMA PET imaging in patients with advanced prostate cancer who are receiving systemic drug therapies.
- Trial name
- PELICAN (NCT07089550)
- Testing
- PSMA PET/CT scan
- Where
- 4 sites in Italy
- Volunteers
- 1,300 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna