Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for High Risk Localized and Locally Advanced Prostate Cancer: A Phase I/Ib Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
United States
Florida
AdventHealth Orlando
RECRUITING
Orlando
Contact Information
Primary
AdventHealth Oncology Research
CFD.ResearchOncology@AdventHealth.com
407-303-2090
Time Frame
Start Date: 2024-10-22
Estimated Completion Date: 2026-06
Participants
Target number of participants: 30
Treatments
Experimental: Combination Therapy Arm
This arm is designed to evaluate the safety and feasibility of the combination therapy using darolutamide and relugolix as neoadjuvant treatment before radical prostatectomy (RP) in patients with high-risk prostate cancer (PCa).
Related Therapeutic Areas
Sponsors
Leads: AdventHealth
Collaborators: Bayer, Sumitomo Pharma Switzerland

This content was sourced from clinicaltrials.gov