Clinical trials: Metastatic Hormone Sensitive Prostate Cancer, open to volunteers
Metastatic Prostate Cancer, Therapy, Directly Observed
Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients
To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy…
- Trial name
- NCT06350825
- Testing
- Cytoreductive prostatectomy or brachytherapy, ADT+second-generation antiandrogens ± chemotherapy
- Where
- China
- Volunteers
- 200 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
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)
Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Carcinoma
FDG-PET-Guided Metastasis Directed Radiation Therapy for the Treatment of Metastatic Hormone Sensitive Prostate Cancer, The PRTY Trial
This phase II trial compares the effect of FDG-positron emission tomography (PET)-guided metastasis directed radiation therapy (MDRT) in combination with standard treatments to standard treatments alone in treating patients with…
- Conditions
- Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
- Trial name
- NCT06244004
- Testing
- Antiandrogen Therapy, Bone Scan, Computed Tomography
- Where
- 6 sites in United States
- Volunteers
- 125 people
- Sponsor
- Northwestern University
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany
Prostate cancer is a disease where cells in the prostate gland grow out of control. When prostate cancer has spread to other parts of the body but still responds to hormone treatment, it is called metastatic hormone-sensitive…
- Trial name
- 23146 (NCT07395804)
- Testing
- darolutamide plus ADT treatment
- Where
- Germany
- Volunteers
- 500 people
- Sponsor
- Bayer
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer
This study aims to compare the efficacy and safety of rezvilutamide with enzalutamide in the treatment of patients with low-volume metastatic hormone sensitive prostate cancer.
- Trial name
- NCT07241416
- Testing
- Rezvilutamide Tablets, Enzalutamide Soft Capsules
- Where
- China
- Volunteers
- 206 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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
Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial.
This is a phase III, randomized, open-label, multi-center study to assess the efficacy of treatment intensification with docetaxel plus apalutamide and ADT, assessed by event-free survival, in patients with mHSPC who do not…
- Trial name
- REINFORCE (NCT07333066)
- Testing
- Apalutamide (Erleada™) 60 mg or 240 mg tablets, Docetaxel
- Where
- 56 sites in France, Germany and 3 more
- Volunteers
- 320 people
- Sponsor
- Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD
Prostate Cancer
Evaluating Treatment Outcomes Using Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer.
This prospective clinical trial aims to investigate the impact of darolutamide in combination with standard-of-care androgen deprivation on physical activity, specifically step count, and its correlation with important markers of…
- Trial name
- NCT06660862
- Testing
- Darolutamide, Physician choice Androgen Deprivation (Hormone) Therapy
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- University of Chicago
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer
The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.
- Trial name
- NCT07140900
- Testing
- Xaluritamig, Darolutamide, Abiraterone
- Where
- 16 sites in United States, Australia and 1 more
- Volunteers
- 60 people
- Sponsor
- Amgen
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
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
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
RISK-ADAPT Protocol in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
This is a prospective, interventional, non-randomized, phase 2 study to assess oncologic outcomes of metastatic hormone-sensitive prostate cancer (mCSPC) patients who receive a risk-adapted treatment approach followed by…
- Trial name
- RISK-ADAPT (NCT07645326)
- Testing
- Androgen Deprivation Therapy (ADT), Androgen Receptor Pathway Inhibitor (ARPI), Prostate Radiation
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- Georgetown University
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
Metastatic Hormone-sensitive Prostate Cancer, Darolutamide (DARO) in Combination With Androgen-deprivation Therapy (ADT) and Docetaxel (DOC)
Evaluation of the Efficacy of Darolutamide Triplet Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer
The purpose of this study is to investigate the clinical efficacy and safety of darolutamide combined with androgen deprivation therapy (ADT) and different dose-intensity docetaxel chemotherapy in the treatment of patients with…
- Trial name
- NCT07031258
- Testing
- Dose of docetaxel
- Volunteers
- 50 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Metastatic Cancer, Neoplasm, Prostate
Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.
The investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC.
- Conditions
- Metastatic Cancer, Neoplasm, Prostate, Castrate-sensitive, Castrate-sensitive Prostate Cancer
- Trial name
- NCT05422911
- Testing
- Abiraterone acetate, Apalutamide, Enzalutamide
- Where
- 12 sites in United States
- Volunteers
- 192 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Prostate Cancer, Castration Sensitive Prostate Cancer
Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery
The purpose of this study is to characterize the reduction in PSMA-avid tumor volume and metastasis-directed radiotherapy treatment intensity facilitated by PET PSMA-response adapted SABR for poly-metastatic castration sensitive…
- Conditions
- Prostate Cancer, Castration Sensitive Prostate Cancer, Metastatic Prostate Cancer, Adaptive Radiotherapy
- Trial name
- RIPCORD (NCT07674771)
- Testing
- Drug: 68-Ga PSMA11, Adaptive stereotactic ablative radiotherapy (SABR), 68Ga-PSMA-11
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Texas Southwestern Medical Center
Prostate Cancer, Radiotherapy Side Effect
Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer
de Novo metastatic prostate cancer with limited metastatic spread benefits from local radiotherapy to the prostate. Two different fractionation schedules will be tested.
- Conditions
- Prostate Cancer, Radiotherapy Side Effect, Metastatic Cancer
- Trial name
- Hypo-M1 (NCT04612907)
- Testing
- Moderate hypo-fractionation, Ultra-hypo-fractionation
- Where
- Sweden
- Volunteers
- 420 people
- Sponsor
- Umeå University
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 Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer
ProBio is an international, outcome-adaptive, multi-arm, open-label, multiple assignment randomized biomarker driven platform trial in patients with metastatic prostate cancer.
- Trial name
- ProBio (NCT03903835)
- Testing
- Enzalutamide Oral Capsule, Abiraterone Oral Tablet, Carboplatin
- Where
- 32 sites in Belgium, Norway and 2 more
- Volunteers
- 750 people
- Sponsor
- Karolinska Institutet
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