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New treatment option for Prostate CA
Official title Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
ClinicalTrials.gov ID: NCT06631521
What this study is testing
What is Darolutamide?
Darolutamide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for prostate ca.
Also referred to as Nubeqa, BAY 1841788.
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 determine the safety and feasibility of a new combination of darolutamide and relugolix as neoadjuvant therapy preceding radical prostatectomy (RP) for high-risk prostate cancer (PCa) in adult males.
- 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
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- ECOG performance status 0-1
- Ability to swallow oral medications and comply with study procedures and requirements.
- Males ≥18 years
- Participants must have adequate organ and marrow function as below:
You likely can't join if
- Histologic variants including neuroendocrine differentiation, small cell, sarcomatoid, ductal adenocarcinoma, squamous or transitional cell...
- Participants who have had chemotherapy or radiotherapy within 4 weeks prior to planned cycle 1 day 1 of study treatment.
- Participants who have received anti-neoplastic intervention or experimental antineoplastic therapy within 14 days of planned cycle 1 day 1 of study...
- Participants who are receiving any other investigational agents.
- Participants who have previously received darolutamide, relugolix, LHRH agonist/antagonist or another novel androgen blocking therapy (abiraterone...
- Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e. have residual toxicities ≥Grade 2) with the exception...
See the full eligibility criteria
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- ECOG performance status 0-1
- Ability to swallow oral medications and comply with study procedures and requirements.
- Males ≥18 years
- Participants must have adequate organ and marrow function as below:
- Absolute neutrophil count (ANC) ≥1,500/mm3 or ≥1.5 x 109/L;
- Platelets ≥100,000/mm3 or ≥100 x 109/L;
- Hemoglobin ≥8 g/dL (may have been transfused).
- Estimated creatinine clearance ≥30 mL/min as calculated using the Cockcroft-Gault equation.
- Total serum bilirubin \<1.5 x upper limit of normal (ULN), less than 2.0 x ULN if suspected Gilbert's syndrome;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 x ULN.
- Must be a candidate for RP
- Clinical stage cT2-4, N0-1
- Mandatory to identify tumor availability (≥10 FFPE slides, 5 µM thickness \& 1 stained H\&E slide OR tumor block)
- High-risk PCa defined as one of the following-
- Gleason score (GS) ≥ 4 + 3 with ≥ 6 positive systematic biopsies (SB)
- GS ≥ 4 + 3 with ≥ 3 SB and prostate-specific antigen (PSA) ≥ 20 ng/mL
- GS ≥ 9 in ≥ 1 SB or targeted biopsies (TB) -≥ 2 SB or TB with continuous GS ≥ 8, each with ≥ 80% involvement.
- Histologic variants including neuroendocrine differentiation, small cell, sarcomatoid, ductal adenocarcinoma, squamous or transitional cell carcinoma) comprising more than 50% of the sample as determined by pathology...
- Participants who have had chemotherapy or radiotherapy within 4 weeks prior to planned cycle 1 day 1 of study treatment.
- Participants who have received anti-neoplastic intervention or experimental antineoplastic therapy within 14 days of planned cycle 1 day 1 of study therapy.
- Participants who are receiving any other investigational agents.
- Participants who have previously received darolutamide, relugolix, LHRH agonist/antagonist or another novel androgen blocking therapy (abiraterone, apalutamide, enzalutamide) within 1 year are excluded (prior...
- Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e. have residual toxicities ≥Grade 2) with the exception of alopecia.
- Any of the following within 6 months before planned cycle 1 day 1 of study therapy:
- Stroke
- Myocardial infarction
- Severe/unstable angina pectoris
- Coronary/peripheral artery bypass graft
- Congestive heart failure New York Heart Association (NYHA) Class III or IV.
- Known or suspected contraindications, hypersensitivity or allergy to darolutamide or relugolix or to any of their excipients.
- Participants with hepatitis C, hepatitis B or human immunodeficiency (HIV) who are on anti-viral therapy that has the potential to interact with darolutamide or relugolix.
- Participants treated with drugs known to be strong inhibitors and/or inducers of cytochrome P450 3A4 (CYP3A4) and the treatment cannot be discontinued or switched to a different medication at least 5 half-lives prior to...
- NOTE: precaution is warranted with concomitant use of agents with a narrow therapeutic index that are substrates of P-gp, BCRP and OCT1.
- The participant has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe...
- Concurrent active malignancy whose natural history or treatment has the potential to interfere with safety or how well it works assessment of the investigational regimen. Patients with non-melanomatous skin cancer...
The study team makes the final eligibility decision.
Where it's taking place
- Orlando, Florida, 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 Orlando, Florida, 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.