Clinical trials: Metastatic Castration-sensitive Prostate Cancer
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
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 Metastatic
Trial of Rucaparib in Patients With Metastatic Hormone-Sensitive Prostate Cancer Harboring Germline DNA Repair Gene Mutations
The aim of this research is to find out if the study drug rucaparib leads to lowering of PSA levels in men with metastatic prostate cancer that has not yet been treated with androgen deprivation therapy (also referred to as…
- Trial name
- TRIUMPH (NCT03413995)
- Testing
- Rucaparib
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Metastatic Prostate Cancer
Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With mCSPC
The goal of this clinical trial is to compare the combination of Darolutamide with Radium-223 or placebo and the effects on radiological progression-free survival for patients with Metastatic Castration-Sensitive Prostrate Cancer…
- Trial name
- CARE (NCT05771896)
- Testing
- Darolutamide, Radium-223
- Sponsor
- GenesisCare USA
Oligoprogressive Prostate Cancer, Metastatic Prostate Cancer
PSMA PET-Staged Comprehensive Progression-Directed Radiotherapy for Limited Progression in Prostate Cancer
PSMA-OLIGO-PRO is a multicenter, ambispective, observational real-world evidence registry of adults with metastatic hormone-sensitive or metastatic castration-resistant prostate cancer who develop a limited number of progressing…
- Trial name
- PSMA-OLIGO-PRO (NCT07691697)
- Testing
- Comprehensive Progression-Directed Radiotherapy
- Where
- Poland
- Volunteers
- 1,000 people
- Sponsor
- Affidea Nu-med Center of Oncological DIagnostics and Therapy
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.
Healthy Volunteers (Intended Indication: Metastatic Patients With Triple Negative or HR+ Breast Cancer, or Hormone Sensitive Prostate Cancer)
A Study to Assess How Itraconazole Affects the Uptake and Elimination of Capivasertib in the Body
This study will be an open-label, fixed sequence study in healthy subjects (vasectomized males and females of non-childbearing potential), performed at a single study centre.
- Trial name
- NCT04712396
- Testing
- Capivasertib, Itraconazole
- Where
- Germany
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Metastatic Prostate Cancer
Real-world Use of Lutetium (177Lu) Vipivotide Tetraxetan in China(PSMAreal CN)
This non-interventional, observational, multicenter, prospective cohort study is designed to investigate the treatment patterns of mPC patients treated with lutetium (177Lu) vipivotide tetraxetan, as well as their clinical…
- Trial name
- PSMAreal (NCT07290270)
- Where
- China
- Volunteers
- 170 people
- Sponsor
- Novartis Pharmaceuticals
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
This phase II trial studies if talazoparib works in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and has mutation(s) in…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Clinical Stage III Gastric Cancer AJCC v8
- Trial name
- NCT04550494
- Testing
- Biopsy Procedure, Biospecimen Collection, Computed Tomography
- Where
- 4 sites in United States
- Volunteers
- 29 people
- Sponsor
- National Cancer Institute (NCI)
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study).
This is a prospective, open-label, dose-escalation and randomized dose optimization and expansion study. The Phase Ib portion of the study aims to determine the safety and tolerability of escalating doses of [212Pb]Pb-ADVC001…
- Conditions
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Metastatic Hormone Sensitive Prostate Cancer
- Trial name
- NCT05720130
- Testing
- [²¹²Pb]Pb-ADVC001 (Phase 1b), [²¹²Pb]Pb-ADVC001 (Phase 2a)
- Where
- 3 sites in Australia
- Volunteers
- 100 people
- Sponsor
- AdvanCell Pty Limited
Metastatic Hormone-sensitive Prostate Cancer
A Trial of Immunotherapy Strategies in Metastatic Hormone-sensitive Prostate Cancer
Metastatic prostate cancer is an incurable disease that typically spreads beyond the prostate. The standard of care is to systemically treat the disease with androgen deprivation therapy (ADT).
- Trial name
- NCT03879122
- Testing
- Ipilimumab 5 MG/ML, Nivolumab 10 MG/ML, Docetaxel
- Where
- 30 sites in Spain
- Volunteers
- 135 people
- Sponsor
- Spanish Oncology Genito-Urinary Group
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.
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
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.
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