Clinical trials: Metastatic Castration-sensitive Prostate Cancer
- Condition Metastatic Castration-sensitive Prostate Cancer
- Funder type Industry (pharma, biotech, devices)
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
[Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer
ACCEL is a multicenter, open label phase Ia/Ib/II study of [Ac-225]-PSMA-62 in participants with prostate-specific membrane antigen (PSMA)-positive prostate cancer.
- Conditions
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Oligometastatic Prostate Carcinoma, Hormone Sensitive Prostate Cancer
- Trial name
- ACCEL (NCT06229366)
- Testing
- [Ac-225]-PSMA-62 (mCRPC), [Ac-225]-PSMA-62 (OmHSPC)
- Where
- 7 sites in Canada
- Volunteers
- 142 people
- Sponsor
- Eli Lilly and Company
Prostate Cancer
Aggressive Disease Treatment Patterns and CtDNA HRR evaluatiON in High-volume metastatiC hORmone-sensitive Prostate Cancer in Russian FeDeration
A multicentre observational study on treatment patterns and ctDNA HRR evaluation in aggressive high-volume metastatic hormone-sensitive prostate cancer in Russian Federation
- Trial name
- CONCORD (NCT07052578)
- Where
- 28 sites in Russia
- Volunteers
- 230 people
- Sponsor
- AstraZeneca
Prostatic Neoplasms
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-MutatedProstatic Neoplasms (mCSPC)
The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination…
- Trial name
- AMPLITUDE (NCT04497844)
- Testing
- Niraparib+ Abiraterone acetate fixed dose combination (FDC), Abiraterone acetate (AA), Prednisone
- Where
- 387 sites in United States, Argentina and 31 more
- Volunteers
- 696 people
- Sponsor
- Janssen Research & Development, LLC
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)
This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus Androgen Deprivation Therapy (ADT) versus placebo plus enzalutamide plus ADT in participants with mHSPC.
- Trial name
- NCT04191096
- Testing
- Pembrolizumab, Enzalutamide, Androgen Deprivation Therapy (ADT)
- Where
- 234 sites in United States, Australia and 27 more
- Volunteers
- 1,251 people
- Sponsor
- Merck Sharp & Dohme LLC
Metastatic Hormone-Sensitive Prostate Cancer
A Study to Learn How Men With Advanced Prostate Cancer Respond to Treatment With Darolutamide and Hormone Therapy, With or Without Chemotherapy, in Real-world Medical Practice
This is an international, prospective, open-label, multicenter, multi-cohort, non-interventional observational study designed to describe the real-world effectiveness and safety of darolutamide in combination with androgen…
- Trial name
- ROAD (NCT07344779)
- Testing
- Darolutamide (BAY 1841788), ADT, Docetaxel
- Where
- 16 sites in Belgium, Finland and 14 more
- Volunteers
- 1,600 people
- Sponsor
- Bayer
Metastatic Castration Sensitive Prostate Cancer (mCSPC), Metastatic Castration Resistant Prostate Cancer (mCRPC)
Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland
Comprehensive understanding of the epidemiology and disease burden of metastatic prostate cancer patients in Finland is lacking.
- Trial name
- NCT05701007
- Testing
- abiraterone, enzalutamide, docetaxel
- Where
- Finland
- Volunteers
- 1,083 people
- Sponsor
- Pfizer
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
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05)
The primary objective of this study is to measure efficacy of saruparib + physician's choice of ARPI compared with placebo + ARPI in men with metastatic hormone-sensitive prostate cancer (mHSPC) who have previously received…
- Trial name
- EvoPAR-PR05 (NCT07711002)
- Testing
- Saruparib, Enzalutamide, Darolutamide
- Where
- 210 sites in United States, Austria and 19 more
- Volunteers
- 1,330 people
- Sponsor
- AstraZeneca
Metastatic Castration-resistant Prostate Neoplasms, Metastatic Hormone-sensitive Prostate Cancer
A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer
The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of pasritamig and combination regimens in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of pasritamig with the…
- Trial name
- NCT05818683
- Testing
- Pasritamig, Cetrelimab, Cabazitaxel
- Where
- 15 sites in United States, Australia and 1 more
- Volunteers
- 300 people
- Sponsor
- Janssen Research & Development, LLC
High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)
Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)
This study was to evaluate the safety and efficacy of dalcilide tablets in combination with AA-P in the treatment of subjects with high tumor burden mHSPC and to determine the second stage starting dose and progression-free…
- Trial name
- NCT06099990
- Testing
- dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets
- Volunteers
- 660 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Metastatic Hormone-sensitive Prostate Cancer
An Observational Study to Learn More About Treatment Patterns and Factors Determining the Choice of Treatment in Canadian Men With Metastatic Hormone Sensitive Prostate Cancer in Routine Medical Care
This is an observational study in which only data are collected from adult Canadian men with metastatic hormone sensitive prostate cancer (mHSPC) are studied.
- Trial name
- RE-ENGAGE (NCT06874114)
- Where
- Canada
- Volunteers
- 477 people
- Sponsor
- Bayer
Prostate Cancer
Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC
The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC.
- Trial name
- NCT04821622
- Testing
- talazoparib plus enzalutamide
- Where
- 312 sites in United States, Argentina and 25 more
- Volunteers
- 599 people
- Sponsor
- Pfizer
Metastatic Castration Resistant Prostate Cancer, Oligometastatic Prostate Cancer (OMPC)
JUR-003 in Adult Patients With Metastatic Prostate Cancer
JUR-003-ONC-101 is a first-in-human Phase 1a/1b open-label, multicenter study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumor activity of JUR-003 in patients with prostate cancer.
- Conditions
- Metastatic Castration Resistant Prostate Cancer, Oligometastatic Prostate Cancer (OMPC), Metastatic Hormone Sensitive Prostate Cancer
- Trial name
- NCT07824349
- Testing
- JUR-003
- Where
- 4 sites in United States
- Volunteers
- 210 people
- Sponsor
- Juri Biosciences, Inc.
Metastatic Castrate-sensitive Prostate Cancer
A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level…
- Trial name
- LIBERTAS (NCT05884398)
- Testing
- Apalutamide, Androgen-deprivation Therapy (ADT)
- Where
- 93 sites in United States, Australia and 7 more
- Volunteers
- 420 people
- Sponsor
- Janssen Research & Development, LLC
Metastatic Hormone-sensitive Prostate Cancer
An Observational Study to Learn More About the Use of Darolutamide as a Part of a Combination Therapy in Belgian Men With Metastatic Hormone-Sensitive Prostate Cancer in Routine Medical Care
This is an observational study in which only observations from routine clinical practices will be made. Participants will not receive any advice on treatment or any changes to healthcare as a part of the study.
- Trial name
- BELBEQA (NCT06498921)
- Testing
- Darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxel
- Where
- Belgium
- Volunteers
- 106 people
- Sponsor
- Bayer
Metastatic Castration-resistant Prostate Cancer, Metastatic Castration-sensitive Prostate Cancer
TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer
The purpose of this study is to investigate the safety and efficacy of a new formulation of an existing drug product called TAVT-45 in patients with metastatic prostate cancer.
- Conditions
- Metastatic Castration-resistant Prostate Cancer, Metastatic Castration-sensitive Prostate Cancer, Metastatic Prostate Cancer
- Trial name
- NCT04887506
- Testing
- TAVT-45, Zytiga, Prednisone
- Where
- 42 sites in United States, France and 6 more
- Volunteers
- 107 people
- Sponsor
- Tavanta Therapeutics
Prostatic Neoplasms
A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces
The purpose of this study is to learn about- for how long are NHTs taken by men to treat mCSPC. NHTs in this study include study medicines: abiraterone, apalutamide, enzalutamide.
- Trial name
- NCT06151418
- Testing
- Novel hormonal therapy
- Where
- United States
- Volunteers
- 2,313 people
- Sponsor
- Pfizer
Metastatic Castration-Sensitive Prostate Cancer
Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants…
- Trial name
- EvoPAR-PR01 (NCT06120491)
- Testing
- Saruparib, Abiraterone Acetate, Darolutamide
- Where
- 322 sites in United States, Australia and 22 more
- Volunteers
- 1,898 people
- Sponsor
- AstraZeneca
Metastatic Castration-Resistant Prostate Cancer, Metastatic Castration-Sensitive Prostate Cancer
Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer
This study is being conducted to assess the safety and tolerability of relugolix with other agents approved for use in combination with androgen deprivation therapy (ADT) for a 12-week treatment period and an additional 40-week…
- Conditions
- Metastatic Castration-Resistant Prostate Cancer, Metastatic Castration-Sensitive Prostate Cancer, Non-Metastatic Castration-Resistant Prostate Cancer
- Trial name
- NCT04666129
- Testing
- Relugolix, Abiraterone, Prednisone
- Where
- 16 sites in United States
- Volunteers
- 48 people
- Sponsor
- Sumitomo Pharma America, Inc.
Prostatic Neoplasms
An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care (SOC), versus Standard of Care alone, in adult male patients with Metastatic hormone sensitive prostate…
- Trial name
- PSMAddition (NCT04720157)
- Testing
- 177Lu-PSMA-617, 68Ga-PSMA-11, ARDT
- Where
- 167 sites in United States, Austria and 17 more
- Volunteers
- 1,140 people
- Sponsor
- Novartis Pharmaceuticals