Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate C… (NCT06631521) | Clinical Trial Compass
RecruitingPhase 1
Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
United States30 participantsStarted 2024-10-22
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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Inclusion 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).
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Percentage of patients completing therapy without severe adverse events.
Timeframe: From enrollment, up to 8 weeks after radical prostatectomy.
2
Number of patients experiencing treatment-related adverse events using CTCAE version 5.0.
Timeframe: From enrollment, up to 8 weeks following radical prostatectomy (RP)
. 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 bicalutamide that was discontinued ≥14 days prior to planned cycle 1 day 1 is allowed).
✕. 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:
✕. Known or suspected contraindications, hypersensitivity or allergy to darolutamide or relugolix or to any of their excipients.