Relugolix + Enzalutamide Study in High-Risk Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Oklahoma
About this trial
The goal of this clinical trial is to test how effective and safe it is to use a combination of two medications, relugolix and enzalutamide, in patients with advanced prostate cancer. We want to see if this combination can help improve the chances of curing the cancer and make the patients live longer without the cancer getting worse.
The main questions we want to answer in this study are:
* Can using relugolix and enzalutamide together help increase the chances of curing high-risk advanced prostate cancer? * Does this combination treatment help patients live longer without their cancer getting worse?
Participants in this study will be asked to take relugolix and enzalutamide as part of their cancer treatment. They will also undergo Radiation Therapy or prostatectomy, which are standard treatments for this type of cancer.
Eligibility criteria
Qualifiers
Capable of giving signed informed consent;
Patients must be ≥18 years of age at the time of signing the informed consent form.
Have normal organ and bone marrow function measured at the screening visit including
Platelets ≥100 × 103/microliter (μL);
Disqualifiers
History of major adverse cardiac event, including myocardial infarction, new congestive heart failure (CHF) or CHF exacerbation, or stroke, within the past 6 months.
Patients who are receiving any other investigational agents.
Patients with distant metastatic cancer will be excluded from the study as intermittent hormonal therapy is not standard of care treatment for this population.
Active secondary malignancies requiring treatment
Trial design
Treatments tested in this trial
- Relugolix and Enzalutamide
Treatment groups
46 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov