Treatment
Darolutamide clinical trials
We’re tracking 46 recruiting studies that include Darolutamide, each written for real people, not researchers, below.
Recruiting studies
- NCT05116475RecruitingPhase 3
New prostate cancer trial adding darolutamide to standard treatment
This Phase 3 trial tests whether adding darolutamide to standard hormone therapy and radiation works better than standard treatment alone for newly diagnosed prostate cancer that has spread to pelvic lymph nodes. If you qualify, you may receive darolutamide or a placebo alongside long-term hormone therapy and radiation.
Chambray-lès-ToursAges 18–120 - NCT06177015RecruitingPhase 3
Darolutamide with chemo for metastatic prostate cancer
This trial tests a new way of using darolutamide (a hormone therapy) together with standard chemotherapy (docetaxel) and hormone therapy (ADT) for men with prostate cancer that has spread. The goal is to see if taking darolutamide on an intermittent schedule works as well as continuous treatment.
Nanjing, JiangsuAges 40–80 - NCT07190300RecruitingPhase 1/Phase 2
Testing tulmimetostat with hormone therapy for metastatic prostate cancer
This trial tests a new drug, tulmimetostat, combined with standard hormone therapies like darolutamide or abiraterone for men with metastatic prostate cancer that still responds to hormone treatment. The goal is to see if the combination works better than standard therapy alone.
Birmingham, AlabamaAges 18 years+ - NCT06785636RecruitingPhase 1/Phase 2
New drug combination for advanced prostate cancer
This study tests a new drug (pocenbrodib) alone or combined with another hormone therapy (darolutamide) for men with advanced prostate cancer that has spread. It is for those who have already tried Pluvicto and one other hormone therapy, but not yet chemotherapy.
Fountain Valley, CaliforniaAges 18 years+ - NCT07538843Recruiting
Darolutamide Plus Hormone Therapy for Prostate Cancer in China
This study watches how well a drug called darolutamide works when combined with hormone therapy for men with prostate cancer that has returned after previous treatment. The goal is to understand if this combination helps prevent cancer spread and is safe to use.
Multiple LocationsAges 18 years+ - NCT07450599RecruitingPhase 2
Darolutamide plus hormone therapy before prostate cancer surgery
This trial tests a medicine called darolutamide taken with hormone therapy (ADT) before surgery to remove the prostate. It is for men with a high-risk prostate cancer that has not spread to other parts of the body.
Hefei, AnhuiAges 18 years+ - NCT06401980RecruitingPhase 2
Darolutamide for advanced prostate cancer that has stopped responding to hormone therapy
This trial tests the drug darolutamide for men whose prostate cancer has spread and is no longer controlled by standard hormone therapy. It may be an option if you've already had certain hormone treatments for at least 12 months but your cancer is still progressing.
AarauAges 18 years+ - NCT06661122Recruiting
Darolutamide with ADT and docetaxel for low-volume metastatic prostate cancer
This study looks at how safe and effective the combination of darolutamide (a tablet), hormone therapy (ADT), and chemotherapy (docetaxel) is for Japanese men with prostate cancer that has spread in a limited way (low volume). It observes people in regular medical care, not in a research setting.
Multiple LocationsAges 18 years+ - NCT07395804Recruiting
How darolutamide works for advanced prostate cancer in Germany
This study looks at how well a drug called darolutamide (a type of hormone therapy) works in everyday medical practice for men with advanced prostate cancer that has spread. It is for men who are already starting this treatment with their doctor and will help doctors understand how it works in real life.
LocationsAges 18 years+ - NCT04916613RecruitingPhase 3
ADT plus darolutamide for vulnerable newly metastatic prostate cancer
This trial studies whether adding darolutamide to standard hormone therapy (ADT) helps men with newly diagnosed metastatic prostate cancer who are physically vulnerable. It aims to control the cancer better while checking safety and how well treatment is tolerated in this group.
CharleroiAges 18 years+ - NCT07244341RecruitingPhase 1
Valemetostat and darolutamide for advanced prostate cancer
This trial tests a new combination of two drugs (valemetostat and darolutamide) for men with metastatic castration-resistant prostate cancer that has worsened after prior treatment. The goal is to see if the combination can slow cancer growth.
La Jolla, CaliforniaAges 18 years+ - NCT05762536RecruitingPhase 2
Docetaxel or cabazitaxel with or without darolutamide
This Phase 2 study tests whether adding darolutamide to either docetaxel or cabazitaxel helps treat men with advanced, progressing prostate cancer. It’s for cancers that have already grown despite hormone-blocking tablets (ARSi).
RotterdamAges 18 years+ - NCT06334120Recruiting
Darolutamide safety study for men with prostate cancer in Korea
This study tracks the safety of the drug darolutamide in Korean men with a type of prostate cancer that has not spread (non-metastatic) or has spread (metastatic) and is still responding to hormone therapy. It aims to see how well patients tolerate the drug in real-world settings.
Multiple LocationsAges 19 years+ - NCT05346848RecruitingPhase 2
Darolutamide plus radiation for intermediate-risk prostate cancer
This trial tests whether adding darolutamide to standard radiation can better control intermediate-risk prostate cancer. It includes men whose cancer has spread nowhere else and who are newly diagnosed with “unfavorable intermediate risk” or progress to that risk group.
AvignonAges 18 years+ - NCT05348876RecruitingPhase 4
Darolutamide plus standard hormone therapy for high-risk prostate cancer
This trial studies how safe darolutamide is and how well it works when added to standard hormone therapy for men with high-risk, non-metastatic prostate cancer that is no longer responding to hormone treatment. It may help slow prostate cancer growth and reduce prostate-specific antigen (PSA) rises in real-world care.
Vijayawada, Andhra PradeshAges 18 years+ - NCT06029036RecruitingPhase 2
Darolutamide and ADT before prostate surgery
This trial tests a combination of darolutamide (a hormone-blocking pill) and standard hormone therapy (ADT) given before prostate surgery. It is for men with high-risk prostate cancer that has not spread to distant parts of the body, to see if the treatment can improve outcomes.
BeijingAges 18–75 - NCT06173362RecruitingPhase 2
Abiraterone or darolutamide for advanced prostate cancer
This study is comparing two drugs, abiraterone and darolutamide, to see how well they work for advanced prostate cancer. You might join if your cancer has spread and your doctor agrees these treatments could help.
Sacramento, CaliforniaAges 18 years+ - NCT06190899RecruitingPhase 1/Phase 2
Testing gedatolisib plus darolutamide in advanced prostate cancer
This trial tests a new combination of two drugs, gedatolisib and darolutamide, in men with prostate cancer that has spread and stopped responding to hormone therapy. The goal is to see if the combination can help control the cancer when standard treatments have stopped working.
Detroit, MichiganAges 18 years+ - NCT06276465RecruitingPhase 3
Darolutamide with or without radiation for advanced prostate cancer
This trial tests whether adding radiation therapy to the drug darolutamide helps men with a specific type of advanced prostate cancer that has stopped responding to hormone therapy and has spread to a few spots seen on special scans. The study aims to find the best way to control the cancer while keeping side effects manageable.
LorientAges 18 years+ - NCT06282588RecruitingPhase 2/Phase 3
Advanced imaging-guided treatment for high-risk prostate cancer
This trial uses a special PET scan (PSMA PET/CT) and a genetic test (Decipher) to decide the best treatment for high-risk prostate cancer that hasn't spread outside the pelvis. You'll receive standard radiation and hormone therapy, possibly with an extra drug (darolutamide).
Wilrijk, AntwerpAges 18 years+ - NCT06575257RecruitingPhase 2
Darolutamide and Hormone Therapy Before Prostate Surgery
This trial tests giving a new hormone-blocking drug (darolutamide) plus standard hormone therapy before surgery for men with high-risk prostate cancer that has not spread. The goal is to see if this approach improves outcomes.
Xi’an, ShanxiAges 18–75 - NCT06625970RecruitingPhase 3
Darolutamide and high-dose radiation for high-risk prostate cancer
This trial tests a combination of a hormone therapy pill (darolutamide) and a high-dose, precise form of radiation for men with localized prostate cancer that has high-risk features of coming back. The goal is to see if this approach is more effective than standard treatment.
BrestAges 18–80 - NCT06631521RecruitingPhase 1
Hormone pills before prostate cancer surgery
This trial tests two oral hormone drugs (darolutamide and relugolix) given before prostate removal surgery for men with high-risk prostate cancer. The goal is to see if this combination shrinks the tumor and improves treatment outcomes.
Orlando, FloridaAges 18 years+ - NCT07406282Recruiting
Darolutamide for new prostate cancer that spread
This study looks at how well darolutamide and similar drugs work for men whose prostate cancer has just spread to other parts of the body. It aims to understand real-world outcomes in urology clinics.
Cleveland, OhioAges 18 years+
What Darolutamide is being studied for
Conditions with recruiting Darolutamide studies.
- Prostate cancer
- Non-metastatic Castration-resistant Prostate Cancer
- Metastatic Castration-resistant Prostate Cancer
- Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
- Stage III Prostate Cancer AJCC v8
- Stage IV Prostate Cancer AJCC v8
- Metastatic Prostate Cancer
- Genital Diseases, Male
- Prostatic Neoplasms, Castration-Resistant
- High Risk Prostate Carcinoma
Common questions
- Are there clinical trials studying Darolutamide?
- Yes. Clin2 currently lists 46 recruiting studies that include Darolutamide, drawn from the U.S. registry and rewritten for real people so you can see what each is testing and who it's for.
- How do I know if I qualify for a Darolutamide trial?
- Each study lists its own eligibility criteria — rules about condition, age, and prior treatments. On every Clin2 trial page we explain these in plain language and offer a short, optional pre-screen for a fit read. The study team makes the final decision.
- Is Darolutamide an approved treatment?
- A drug being studied in a trial may be investigational (still being tested) or already approved and being studied for a new use. Each study page explains what phase it's in. Clin2 does not provide medical advice — talk with your doctor about whether Darolutamide or a specific trial is right for you.
Related treatments
Clin2 helps you find and understand clinical trials and does not provide medical advice. Study data comes from ClinicalTrials.gov. A drug appearing here is being studied in a trial and may be investigational. Talk with your doctor about whether a specific treatment or trial is right for you.