Treatment
Darolutamide clinical trials
We’re tracking 49 recruiting studies that include Darolutamide, each written for real people, not researchers, below.
Recruiting studies
- 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 - NCT07871110RecruitingPhase 2
New pill combined with hormone therapy for advanced prostate cancer
This study tests a new pill (TT00420) taken with standard hormone therapy for prostate cancer that has spread and is no longer responding to initial hormone treatment. The goal is to see if the combination can help slow the cancer's growth and is safe.
Fuzhou, FujianAges 18 years+ - 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 - NCT07190300RecruitingPhase 1/Phase 2
Study of tulmimetostat plus other hormone therapies for metastatic prostate cancer
This study tests two different combinations of drugs for men with prostate cancer that has spread to other parts of the body but still responds to hormone therapy. It compares a new pill (tulmimetostat) combined with standard treatments like darolutamide or abiraterone to see if it can help control the cancer longer.
Birmingham, AlabamaAges 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 - NCT07617272RecruitingPhase 2
Testing a drug to shrink high-risk prostate cancer before surgery
This trial tests whether a hormone-blocking drug called darolutamide can shrink aggressive prostate cancer before surgery. Researchers will also use a special blood test to predict who benefits most from the treatment.
GothenburgAges 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+ - 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+ - NCT07503379RecruitingPhase 2
Darolutamide, hormone therapy and low-dose docetaxel for metastatic prostate cancer
This trial tests a combination of two drugs (darolutamide plus hormone therapy) along with a low dose of chemotherapy (docetaxel) for men whose prostate cancer has spread to other parts of the body. It aims to see if this combined approach is safe and effective.
Guangzhou, GuangdongAges 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+ - 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+ - 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+ - 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+ - NCT07142551RecruitingPhase 2
Testosterone priming with darolutamide for metastatic prostate cancer
This trial tests whether giving a high dose of testosterone before standard hormone therapy can help the treatment work longer for men with prostate cancer that has spread. You would receive testosterone injections for a short time, then a hormone blocker (darolutamide) along with continued testosterone shots.
Baltimore, MarylandAges 18 years+ - NCT07027124RecruitingPhase 2
High-risk prostate cancer treatment before and after surgery
This trial tests a combination of hormone therapy, a targeted pill (Darolutamide), and an immunotherapy drug (Pembrolizumab) before and after surgery for men with high-risk prostate cancer that has specific genetic features. The goal is to see if this approach helps prevent the cancer from coming back.
New York, New YorkAges 18 years+ - NCT07016399RecruitingPhase 2
Darolutamide before surgery for AR-positive triple-negative breast cancer
This trial tests a drug called darolutamide, alone or with standard chemotherapy, before surgery for a type of breast cancer that is triple-negative but has a high level of the androgen receptor (AR). It is for people with stage II or IIIA breast cancer that can be removed surgically.
Nashville, TennesseeAges 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+ - 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+ - 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+ - 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+ - 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+ - 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+ - 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+
What Darolutamide is being studied for
Conditions with recruiting Darolutamide studies.
Common questions
- Are there clinical trials studying Darolutamide?
- Yes. Clin2 currently lists 49 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.