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Darolutamide + Abemaciclib for Prostate Cancer
Study Summary
This trial is researching the safety and effectiveness of two oral drugs (Darolutamide and Abemaciclib) combined with androgen deprivation therapy for prostate cancer. 93 patients will take part for 6 months with up to 4.5 years of follow-up.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have a history of cancer.My organs and bone marrow are working well.I haven't had cancer in the last 5 years, except for skin cancer.I have other medical conditions or another active cancer.I am a man aged 18 or older.I can take pills and follow study rules.I have had a condition where my lymphocytes grow abnormally.I haven't had cancer treatment or experimental therapy in the last 14 days.I have taken darolutamide, abemaciclib, or another CDK4/6 inhibitor before.My prostate cancer is advanced but hasn't spread or has spread, and it's getting worse despite hormone therapy.I am taking medication that interacts with the study drug.I have brain metastases that are either untreated or getting worse.My prostate cancer is mainly adenocarcinoma, confirmed by a specialist review.I haven't had chemotherapy or radiotherapy in the last 4 weeks.I can take care of myself but might not be able to do heavy physical work.
- Group 1: Phase 1 Lead In in CRPC
- Group 2: Phase 2 - Neoadjuvant Darolutamide and ADT prior to Radical Prostatectomy
- Group 3: Phase 2 - Neoadjuvant Darolutamide, Ademaciclib, and ADT prior to Radical Prostatectomy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the goals that researchers hope to achieve with this clinical trial?
"The primary goal of this study, which will be assessed over the course of 28 days in Cycle 1 and up to 6 months, is Pathological Response Rate inPhase 2. Additionally, researchers are measuring secondary objectives like Grade 3 or Higher Treatment-Related Toxicity Rate in Phase 1 & 2 (which is defined as all grade 3 or higher adverse events with treatment attribution), Proportion free from [Prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) Therapy in Phase 2 (defined as the proportion of patients who do not need further prostate cancer therapy), and Median Radiographic Progression-Free Survival in Phase 1 (defined as the time from protocol treatment initiation until disease progression or death"
Are we still recruiting test subjects for this experiment?
"According to the information available on clinicaltrials.gov, this particular trial is not currently looking for recruits. The last time it was updated was on November 14th, 2022. There are 1373 other trials that patients can take part in right now."
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