Treatment
Darolutamide clinical trials
We’re tracking 44 recruiting studies that include Darolutamide, each written for real people, not researchers, below.
Recruiting studies
- 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+ - 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+ - 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+ - NCT03903835RecruitingPhase 3
Biomarker-guided treatment for metastatic prostate cancer
This Phase 3 trial tests a prostate cancer treatment plan chosen using your tumor’s biomarker results. It aims to improve outcomes for men with metastatic prostate cancer starting first systemic treatment.
AalstAges 18 years+ - NCT05818683RecruitingPhase 1
Pasritamig plus other drugs for advanced prostate cancer
This Phase 1 study tests pasritamig (JNJ-78278343) combined with other prostate cancer treatments in people with advanced prostate cancer that has spread. It aims to find the safest dose and see whether the combinations can help slow the cancer.
Sarasota, FloridaAges 18 years+ - NCT06220864RecruitingPhase 1
Testing SNV1521 for advanced solid tumors
This trial tests a new oral drug called SNV1521 for people with advanced solid tumors that have not responded to other treatments. It aims to see if the drug is safe and how well it works against different types of cancer.
New Haven, ConnecticutAges 18 years+ - NCT07723248RecruitingPhase 3
Oral Rinzimetostat for Advanced Prostate Cancer After Abiraterone
This study tests an experimental pill called rinzimetostat (ORIC-944) for men with advanced prostate cancer that has spread and stopped responding to abiraterone. It may offer a new option if you have not had many other treatments yet.
Charlotte, North CarolinaAges 18 years+ - NCT06378866RecruitingPhase 2
Radiation with hormone therapy timing for prostate cancer
This study is testing whether using focused radiation beams (SBRT) right away or later, along with hormone therapy, can help control prostate cancer that has returned in a few spots outside the pelvis. The goal is to find the best timing for combining radiation and hormone treatment.
Phoenix, ArizonaAges 18 years+ - NCT06592924RecruitingPhase 3
Adding chemo to hormone therapy for prostate cancer with slow PSA drop
This trial tests if adding docetaxel chemotherapy helps men whose PSA hasn't dropped enough after at least 6 months of standard hormone therapy (ADT) plus an ARPI pill (like abiraterone or enzalutamide) for metastatic prostate cancer that still responds to hormones.
Anchorage, AlaskaAges 18 years+ - NCT05519449RecruitingPhase 1
Testing a PSMA-targeting treatment for advanced prostate cancer
This Phase 1 trial tests JANX007 in men with metastatic castration-resistant prostate cancer (cancer that keeps growing despite standard hormone treatment). It aims to find a safe dose and see whether the treatment can shrink tumors or slow progression.
Birmingham, AlabamaAges 18–100 - NCT06473259Recruiting
Comparing treatments for hormone-sensitive metastatic prostate cancer
This trial looks at combining hormone therapy with either chemotherapy (docetaxel), a targeted pill (like abiraterone or enzalutamide), or radiation to the prostate tumor for men whose prostate cancer has spread but is still sensitive to hormones. The goal is to see which approach works best for controlling the cancer.
Orbassano, TorinoAges Any age - NCT05413421RecruitingPhase 1
ORIC-944 for metastatic prostate cancer after hormone therapy
This early-phase trial tests ORIC-944 to see how well it works and what dose is safest for metastatic prostate cancer that has progressed after hormone-targeted pills. It may help people whose cancer has stopped responding to prior prostate cancer hormone treatments.
Colorado Springs, ColoradoAges 18 years+ - NCT06568094RecruitingPhase 1/Phase 2
Study of HRS-5041 with other drugs for advanced prostate cancer
This trial tests a new tablet called HRS-5041 combined with other anti-cancer treatments for men with advanced prostate cancer that has not responded to previous therapies. It aims to see how well the combination works and if it is safe.
Harbin, HeilongjiangAges 18–80 - NCT06652607Recruiting
PSA response as a sign of treatment success in prostate cancer
This trial is for men with prostate cancer that has spread to other parts of the body and is being treated with hormone therapy. It looks at whether a drop in PSA levels after six months can help predict how well the treatment is working.
Rome, LazioAges 18 years+ - NCT06724159Recruiting
Study of funded drugs for genitourinary cancers
This study looks at how well newer funded cancer drugs work for people with cancers of the urinary or reproductive systems, such as bladder, prostate, or kidney cancer. Researchers want to learn about real-world outcomes based on routine care in hospitals across Spain.
Albacete, AlbaceteAges 18 years+ - NCT07103018RecruitingPhase 1
Study of KTX-2001 for men with advanced prostate cancer
This trial tests a new drug called KTX-2001, possibly combined with another drug (darolutamide), for men whose prostate cancer has spread and stopped responding to standard hormone treatments. The goal is to see if it can help shrink tumors or slow the cancer's growth.
San Francisco, CaliforniaAges 18 years+ - NCT07140900RecruitingPhase 1
Study of xaluritamig combined with hormone therapy for advanced prostate cancer
This trial tests a new drug, xaluritamig, given with standard hormone therapy for men with prostate cancer that has spread to other parts of the body (metastatic) and is still sensitive to hormone therapy. It aims to see if the combination is safe and works better than hormone therapy alone.
San Francisco, CaliforniaAges 18 years+ - NCT07172685Recruiting
Triple therapy plus HIFU for high-tumor-burden prostate cancer
This trial tests a combination of hormone therapy, chemotherapy (docetaxel), and a targeted drug (apalutamide) with a focused ultrasound procedure (HIFU) for men with prostate cancer that has spread to many bones or organs. It may help control the cancer more effectively.
Jinan, ShandongAges 18 years+ - NCT07611110RecruitingPhase 3
AZD2265 vs standard care for advanced prostate cancer
This trial tests a new cancer-fighting drug called AZD2265 against standard treatment for men with advanced prostate cancer that has spread and stopped responding to hormone therapy. You may qualify if your cancer previously responded to PSMA-targeted radiation treatments but is now growing again.
Dothan, AlabamaAges 18 years+ - NCT07672119Recruiting
Heart risks in older men on enzalutamide or darolutamide
This study looks at heart-related risks in older men with advanced prostate cancer who are taking enzalutamide or darolutamide. It may help doctors better understand how to manage heart health during treatment.
Whippany, New JerseyAges 55 years+
Common questions
- Are there clinical trials studying Darolutamide?
- Yes. Clin2 currently lists 44 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.