Actively Recruiting
Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for High Risk Localized and Locally Advanced Prostate Cancer: A Phase I/Ib Trial
Led by AdventHealth · Updated on 2026-02-05
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
AdventHealth
Lead Sponsor
B
Bayer
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of a new combination of darolutamide and relugolix as a pre-surgery treatment for adult males with high-risk prostate cancer. This phase 1 trial focuses on men who are candidates for radical prostatectomy to treat localized or locally advanced prostate cancer. The study aims to understand how well patients tolerate this combination before surgery and monitor for any treatment-related side effects. Participants will receive darolutamide orally at a dose of 600 mg twice daily and relugolix with a loading dose of 360 mg on the first day followed by 120 mg once daily. After completing this neoadjuvant therapy, radical prostatectomy will be performed between 48 hours and 2 weeks later. This treatment arm is designed to assess the combination's safety and feasibility prior to surgery. During the study, patients will be monitored for adverse events up to 8 weeks after surgery, and researchers will measure objective radiographic response, prostate-specific antigen (PSA) levels, and blood concentrations of the drugs during treatment cycles. The total participation includes treatment, surgery, and follow-up assessments to evaluate safety and therapy completion rates.
CONDITIONS
Brief Title
Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- ECOG performance status of 0 or 1
- Ability to swallow oral medications and comply with study procedures
- Male participants aged 18 years or older
- Adequate organ and marrow function with specific blood count and liver function levels
- Candidate for radical prostatectomy
- Clinical stage cT2-4, N0-1 prostate cancer
- Availability of tumor tissue samples for analysis
- High-risk prostate cancer defined by Gleason score and biopsy criteria
You will not qualify if you...
- Histologic variants comprising more than 50% of the tumor sample such as neuroendocrine differentiation or small cell carcinoma
- Chemotherapy or radiotherapy within 4 weeks prior to study treatment
- Use of anti-neoplastic or experimental therapies within 14 days prior to study treatment
- Receiving other investigational agents
- Prior use of darolutamide, relugolix, or similar androgen blocking therapies within 1 year
- Unresolved side effects from prior cancer therapy greater than Grade 2, except alopecia
- History of serious cardiovascular events or conditions within 6 months prior to study treatment
- Known allergies or contraindications to darolutamide or relugolix
- Active hepatitis B, C, or HIV on antiviral therapy that may interact with study drugs
- Use of drugs strongly affecting cytochrome P450 3A4 that cannot be stopped
- Serious uncontrolled medical conditions that would prevent study participation
- Concurrent active cancers that could interfere with safety or efficacy assessments except certain low-risk cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive a combination of darolutamide and relugolix as neoadjuvant therapy before undergoing radical prostatectomy.
Regular visits during neoadjuvant therapy and up to surgery
Duration - Up to 2 weeks
Participants undergo radical prostatectomy performed at least 48 hours and within 2 weeks after completing neoadjuvant therapy.
1 surgical visit plus post-operative care visits
Duration - 8 weeks
Participants are monitored for safety and treatment outcomes up to 8 weeks following radical prostatectomy.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 1 location
1
AdventHealth Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
Research Team
A
AdventHealth Oncology Research
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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