Actively Recruiting

Phase 1
Age: 18Years +
MALE
NCT06631521

Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer

Led by AdventHealth · Updated on 2026-02-05

30

Participants Needed

1

Research Sites

83 weeks

Total Duration

On this page

Sponsors

A

AdventHealth

Lead Sponsor

B

Bayer

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

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, 18 years or older
  • Adequate organ and marrow function including ANC 61,500/mm3, platelets 6100,000/mm3, hemoglobin 68 g/dL, creatinine clearance 630 mL/min, bilirubin <1.5 x ULN (or <2.0 x ULN if suspected Gilbert's syndrome), AST and ALT <2.5 x ULN
  • Candidate for radical prostatectomy
  • Clinical stage cT2 to cT4, N0 to N1
  • Availability of tumor tissue (at least 10 FFPE slides or 1 stained H&E slide or tumor block)
  • High-risk prostate cancer defined by Gleason score and biopsy criteria: GS 6 4+3 with 66 positive systematic biopsies, or GS 6 4+3 with 63 biopsies and PSA 620 ng/mL, or GS 69 in 1 biopsy or targeted biopsies with continuous GS 68 and 80% involvement
Not Eligible

You will not qualify if you...

  • Histologic variants making up more than 50% of sample including neuroendocrine differentiation, small cell, sarcomatoid, ductal adenocarcinoma, squamous or transitional cell carcinoma
  • Chemotherapy or radiotherapy within 4 weeks before starting study treatment
  • Anti-neoplastic or experimental therapy within 14 days before starting study treatment
  • Current use of other investigational agents
  • Prior treatment with darolutamide, relugolix, LHRH agonist/antagonist, or novel androgen blocking therapy within 1 year (except bicalutamide discontinued at least 14 days prior)
  • Unresolved toxicities 6Grade 2 from prior anti-cancer therapy (except alopecia)
  • History of stroke, myocardial infarction, severe or unstable angina, bypass graft, or congestive heart failure NYHA Class III or IV within 6 months
  • Known allergy or contraindication to darolutamide or relugolix
  • Hepatitis B, hepatitis C, or HIV with antiviral therapy that may interact with study drugs
  • Use of strong CYP3A4 inhibitors or inducers that cannot be stopped at least 5 half-lives before study drug
  • Serious uncontrolled medical conditions that preclude study participation
  • Active malignancy that may interfere with study safety or efficacy except certain skin, bladder, or previously treated cancers in remission for at least 3 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

AdventHealth Orlando

Orlando, Florida, United States, 32803

Actively Recruiting

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Research Team

A

AdventHealth Oncology Research

CONTACT

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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