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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Relugolix and Enzalutamide
DrugDose level of Relugolix and Enzalutamide Safety Lead-in Cohort, 3-12 patient. Relugolix;120 mg, oral, once daily, with a loading dose of 360 mg on day 1, Enzalutamide; 120-160 mg, oral, once daily. Dose Expansion Cohort, up to 34 patients. Relugolix;120 mg, oral, once daily, with a loading dose of 360 mg on day 1, Enzalutamide; To be determined by safety lead-in cohort. One cycle = 3 months The dose limiting toxicity (DLT) period is the first 28 days Neoadjuvant ADT: 6 months; Relugolix: 120 mg orally, daily (with a 360 mg loading dose on day 1, Enzalutamide: 160 mg (or 120 mg) orally, daily Concurrent ADT during Radiation Therapy; Relugolix: 120 mg orally, daily (with a 360 mg loading dose on day 1, Enzalutamide: 160 mg (or 120 mg) orally, daily Maintenance ADT: Additional 18 months; Relugolix: 120 mg orally, daily (with a 360 mg loading dose on day 1, Enzalutamide: 160 mg (or 120 mg) orally, daily
Treatment groups
46 Participants
are divided into 1 treatment groupGroup A: Prostate Cancer Combo Therapy TrialExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patient experiencing dose limiting toxicity (DLT) and tolerable dose of relugolix and enzalutamide combination
Proportion of patients will undergo evaluation for dose-limiting toxicity (DLT) to establish a tolerable dosage regimen for the combined use of relugolix and enzalutamide in individuals diagnosed with high-risk locally advanced prostate cancer. The assessment hinges on identifying DLTs associated with this treatment using 3-12 patients from the safety lead-in cohort and continuously monitoring treatment-related adverse events throughout the DLT observation period, which spans 24 months, encompassing neoadjuvant and adjuvant treatment phases.
Time frame
2-3 years2
Proportion of patients experiencing Pathologic Complete Response (pCR) and Minimal Residual Disease (MRD) in Neoadjuvant ADT with the combination of Relugolix and Enzalutamide
Proportion of patients achieving a pathologic response rate, defined as the combined Pathologic Complete Response (pCR) Rate and Minimal Residual Disease (MRD) rate (MRD, tumor ≤5 mm), serves as the primary endpoint for the dose expansion cohort. This assessment will be conducted using Simon's optimal 2-stage design, enabling a determination of whether there are an adequate number of patients with objective responses to proceed to the second stage of the study (at the interim analysis) or to consider the drug for further investigation in a Phase III study (at the study's conclusion).
Time frame
4-6 yearsSecondary outcomes
1
Objective response rate (ORR) of neoadjuvant ADT of relugolix and enzalutamide
Assessing the objective response rate (ORR) in patients with high-risk locally advanced prostate cancer eligible for definitive radiation therapy (RT) or radical prostatectomy, following neoadjuvant ADT with relugolix and enzalutamide. ORR will be determined based on MRI imaging confirmation, defined as the percentage of patients achieving a complete response (CR) or partial response (PR) per RECIST v1.1 criteria.
Time frame
4-6 years2
Frequency and severity of adverse events of relugolix and enzalutamide
Assessment includes the rate and severity of treatment-related adverse events as per the NCI CTCAE v5 grading system.
Time frame
4 years3
Prostate specific antigen (PSA) response to the combination of relugolix and enzalutamide
Measurement of prostate-specific antigen (PSA) response, includes the rate and duration of a 50% reduction in PSA levels from baseline.
Time frame
4 years4
Diagnostic precision and constraints of biopsy in assessing positive margin rates and rates of pathologic downgrade.
Assessments involves diagnostic capabilities of biopsy-based analysis for prostatectomy, as reflected in the rates of positive margin in whole-mount pathology following intense neoadjuvant therapy and the pathologic downgrade compared to the initial T stage.
Time frame
4-6 yearsSponsors and contacts
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Source ClinicalTrials.gov