BridgeMD
New treatment option for Androgen Deprivation Therapy
Official title Relugolix + Enzalutamide Study in High-Risk Prostate Cancer
ClinicalTrials.gov ID: NCT06130995
What this study is testing
What is Relugolix and Enzalutamide?
Relugolix and Enzalutamide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for androgen deprivation therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Capable of giving signed informed consent;
- Patients must be ≥18 years of age at the time of signing the informed consent form.
- Men with a diagnosis of adenocarcinoma of the prostate pathologically proven diagnosis with the following:
- Locally advanced high-risk prostate defined as i. PSA \>20 ng/mL or ISUP grade 4/5 (Gleason score \>7) or cT2c or ii. Any PSA, any ISUP grade, cT3-4...
- Have normal organ and bone marrow function measured at the screening visit including
You likely can't join if
- History of major adverse cardiac event, including myocardial infarction, new congestive heart failure (CHF) or CHF exacerbation, or stroke, within...
- 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...
- Active secondary malignancies requiring treatment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of study drugs
- Participants with uncontrolled intercurrent illness.
See the full eligibility criteria
- Capable of giving signed informed consent;
- Patients must be ≥18 years of age at the time of signing the informed consent form.
- Men with a diagnosis of adenocarcinoma of the prostate pathologically proven diagnosis with the following:
- Locally advanced high-risk prostate defined as i. PSA \>20 ng/mL or ISUP grade 4/5 (Gleason score \>7) or cT2c or ii. Any PSA, any ISUP grade, cT3-4 or cN+ (locally advanced)
- Have normal organ and bone marrow function measured at the screening visit including
- Platelets ≥100 × 103/microliter (μL);
- Hemoglobin ≥ 10.0 grams/dL;
- Leukocytes (WBC) ≥ 3 × 103/μL;
- Absolute neutrophil count ≥1.5 × 103/μL;
- Serum AST and ALT ≤2.5 × upper limit of normal (ULN);
- Total bilirubin ≤1.5 ×ULN (unless values are consistent with Gilbert's syndrome for which the total bilirubin must be \< 3x ULN);
- Serum creatinine ≤ 1.5 × ULN; OR Measured or calculated creatinine clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- The participant has, in the opinion of the investigator, a life expectancy of at least 6 months.
- Male patients must be willing to use contraception during treatment and for 3 months after the last dose of study treatment when having sexual intercourse with a pregnant woman or with a woman of childbearing potential...
- 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
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of study drugs
- Participants with uncontrolled intercurrent illness.
- Participant is unable to swallow pills.
- Not a candidate for surgical or radiation therapy
The study team makes the final eligibility decision.
Where it's taking place
- Oklahoma City, Oklahoma, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oklahoma City, Oklahoma, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.