Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorAdventHealth
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 review
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.
Trial design
Design model
Single group
Treatments tested in this trial
Darolutamide
Drug600 mg (two 300 mg tablets) taken orally twice daily.
Relugolix
DrugA loading dose of 360 mg on the first day, followed by 120 mg taken orally once daily.
Radical Prostatectomy
Procedure/SurgeryPerformed at least 48 hours and within 2 weeks after the completion of neoadjuvant therapy.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Combination Therapy ArmExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Percentage of patients completing therapy without severe adverse events.
Time frame
From enrollment, up to 8 weeks after radical prostatectomy.2
Number of patients experiencing treatment-related adverse events using CTCAE version 5.0.
Time frame
From enrollment, up to 8 weeks following radical prostatectomy (RP)Secondary outcomes
1
Objective Radiographic Response
Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes in millimeters (mm). Response refers to the reduction in tumor size according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) criteria (Complete Response, Partial Response, Stable Disease, or Progressive Disease).
Time frame
From enrollment, up to 12 weeks (end of neoadjuvant therapy).2
Prostate-specific antigen (PSA) Response
The unit of measure is nanograms per milliliter (ng/mL). A PSA response is defined as a decline of ≥50% from baseline levels.
Time frame
From enrollment, up to 8 weeks after radical prostatectomy.3
Plasma Concentration of Darolutamide and Relugolix
This measure involves assessing the plasma concentration of darolutamide and relugolix at specified time points to determine their pharmacokinetic profiles. Units of measure: Concentration in nanograms per milliliter (ng/mL).
Time frame
From enrollment, up to Day 1 of Cycle 3 (Each cycle is 28 days).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov