Valemetostat + Darolutamide for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of two drugs, valemetostat and darolutamide, for treating prostate cancer that has spread and does not respond to hormone therapy. The study consists of two parts: first, determining the right dose, and then testing different doses to assess their combined effectiveness. Eligible participants have been diagnosed with metastatic prostate cancer, are undergoing hormone therapy, and have a measurable specific protein level in their blood. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial requires that participants continue their current androgen deprivation therapy throughout the study. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that darolutamide, one of the treatments in this study, is generally safe for patients. Studies involving patients with hormone-sensitive prostate cancer have found that darolutamide can extend life with a low risk of serious side effects. For instance, only a small number of patients (4.5% in one study) needed to reduce their dose due to side effects.
Valemetostat, however, is still under investigation for its safety, especially in combination with darolutamide. This combination aims to treat advanced prostate cancer, but as this is an early-stage study, detailed safety information remains limited. Early-stage studies often focus on determining the best dose and assessing patient tolerance.
Overall, darolutamide is known to be well-tolerated, but the combination with valemetostat requires further research. Participants in this trial will contribute to understanding the safety of using these two treatments together.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Valemetostat and Darolutamide for prostate cancer because it offers a novel approach to treatment. Valemetostat is a unique drug because it targets epigenetic changes, potentially disrupting cancer cell growth in a different way compared to traditional hormone therapies like androgen deprivation therapy. Meanwhile, Darolutamide is a next-generation androgen receptor inhibitor that has shown effectiveness with fewer side effects. Combining these two powerful agents might enhance treatment efficacy and improve outcomes for patients with prostate cancer.
What evidence suggests that this trial's treatments could be effective for prostate cancer?
Research has shown that darolutamide effectively treats prostate cancer. In patients with metastatic hormone-sensitive prostate cancer (mHSPC), 91% did not experience cancer worsening after 12 months on darolutamide, indicating that most patients' cancer did not progress during that period. Additionally, 83% of patients taking darolutamide survived for three years. While less information is available on valemetostat, it is believed to block certain enzymes that cancer cells need to grow. This trial will study the combination of valemetostat and darolutamide to determine if they work better together against prostate cancer. Participants will receive valemetostat at escalating or multiple dose levels combined with darolutamide to evaluate their combined effectiveness.12367
Are You a Good Fit for This Trial?
This trial is for adult males with advanced prostate cancer that has spread and resisted castration treatment. They must have a PSA level of ≥2 ng/mL, confirmed adenocarcinoma (except pure small cell carcinoma), documented disease progression, metastasis visible on scans, ongoing hormone therapy started at least 4 weeks before the trial, and previous ARPI therapy. Participants should be in good physical condition with an ECOG PS score of 0 or 1.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants will receive valemetostat at escalating doses in combination with darolutamide
Dose Expansion
Participants will receive valemetostat at 2 or more dose levels in combination with darolutamide
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Darolutamide
- Valemetostat
Trial Overview
The study tests the combination of two drugs: Valemetostat and Darolutamide in men with metastatic castration-resistant prostate cancer. It aims to determine how safe this combo is and how well patients tolerate it.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will receive valemetostat at 2 or more dose levels in combination with darolutamide.
Participants will receive valemetostat at escalating doses in combination with darolutamide.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Daiichi Sankyo
Lead Sponsor
Hiroyuki Okuzawa
Daiichi Sankyo
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
Yuki Abe
Daiichi Sankyo
Chief Medical Officer since 2023
MD
Bayer
Industry Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD
Citations
NCT07244341 | A Study of Valemetostat (DS-3201b) in ...
This study will assess the safety and tolerability of valemetostat in combination with darolutamide in participants with Metastatic Castration Resistant ...
Assessing the efficacy of darolutamide in metastatic hormone ...
This meta-analysis aims to assess the efficacy of darolutamide in mHSPC based on subgroups and reconstructed individual-level data.
Real world outcomes of darolutamide efficacy and safety in ...
At 12 months, biochemical progression-free survival (bPFS) rates were 72.8% for nmHSPC and 91% for mHSPC. Discontinuation due to voluntary ...
Efficacy outcomes 12 months after initiation of ...
Conclusions: This RWE shows that patients with nmCRPC in clinical practice have comparable outcomes to the ARAMIS trial. Response rates, ...
Nonmetastatic, Castration-Resistant Prostate Cancer and ...
Overall survival at 3 years was 83% (95% confidence interval [CI], 80 to 86) in the darolutamide group and 77% (95% CI, 72 to 81) in the placebo ...
6.
journals.lww.com
journals.lww.com/annals-of-medicine-and-surgery/fulltext/2025/12000/safety_and_efficacy_of_darolutamide_in_combination.123.aspxSafety and efficacy of darolutamide in combination with...
This study evaluated the safety and efficacy of darolutamide with ADT in patients with hormone-sensitive prostate cancer and CRPC compared to ADT plus placebo.
Efficacy and safety outcomes of darolutamide in patients ...
Darolutamide significantly improved median metastasis-free survival by nearly 2 years and reduced the risk of death by 31% versus placebo, with a favourable ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.