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Enzalutamide + Ribociclib for Prostate Cancer
Study Summary
This trial is studying the side effects and best dose of ribociclib when given with enzalutamide to see how well they work compared to enzalutamide alone in treating patients with prostate cancer.
- Prostate Cancer
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have a condition in your stomach or intestine that might affect how the study drug is absorbed.You have a condition affecting your brain or spinal cord, unless it meets certain criteria.You have severe peripheral neuropathy, with a score of more than 2.You cannot take any hormonal medications during the trial and must stop using them before you can participate.If you are a sexually active man, you must use a condom during sex while taking the drug and for 30 days after stopping treatment.You had radiation treatment within the past 4 weeks or limited radiation treatment for relief within the past 2 weeks.You cannot have participated in another study using an experimental medication within the past month or within 5 half-lives of that medication.You have previously taken enzalutamide or other experimental treatments targeting androgen receptors.You cannot start taking bisphosphonate or denosumab medication while participating in the study.
- Group 1: Enzalutamide + Ribociclib
- 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
Are there any slots still available for individuals to join this experiment?
"Affirmative. According to clinicaltrials.gov, this research project is actively seeking participants after having been posted on December 1st 2015 and recently updated October 18th 2022. A total of 90 patients must be recruited from 4 study sites."
How many participants are currently part of this research experiment?
"To meet the trial's requirements, 90 individuals who have passed the inclusion criteria must enroll. There are various locations available to receive treatment such as University of Michigan Comprehensive Cancer Center in Ann Arbor and Memorial Sloan Kettering Cancer Centre in New york state."
Is there any prior research concerning the use of Ribociclib?
"Researched at the Rosemere Cancer Centre of Royal Preston Hospital in 2005, ribociclib has seen 115 completed trials to date. Currently 145 active clinical studies are underway and some have been conducted out of Ann Arbor, Michigan."
In what therapeutic contexts is Ribociclib commonly applied?
"Ribociclib can assist in the management of malignant neoplasms, post-menopausal symptoms, and castration."
Is the clinical trial being administered at multiple healthcare centers in North America?
"Currently, there are 4 sites actively recruiting patients. These include Ann Arbor, New york and Philadelphia plus 1 additional medical centre; we suggest that you opt for the closest one to reduce travel strain should you choose to join this trial."
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