Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer

Part of paid clinical trials in Orlando, Florida.

Sponsor
AdventHealth
Study ID
NCT06631521
Phase
PHASE1
Status
Recruiting
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Conditions

  • Prostate CA
  • Prostate Cancer (Adenocarcinoma)
  • Prostate Cancer Surgery

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Darolutamide — DRUG
    600 mg (two 300 mg tablets) taken orally twice daily.
  • Relugolix — DRUG
    A loading dose of 360 mg on the first day, followed by 120 mg taken orally once daily.
  • Radical Prostatectomy — PROCEDURE
    Performed at least 48 hours and within 2 weeks after the completion of neoadjuvant therapy.

Study Details

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.

Key Dates

Start date
Oct 22, 2024
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Percentage of patients completing therapy without severe adverse events. [ Time Frame: From enrollment, up to 8 weeks after radical prostatectomy. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
AdventHealth OrlandoOrlandoFlorida32803
AdventHealth Oncology Research
[email protected]
407-303-2090

Find similar trials in Orlando, FL

By research site
AdventHealth Orlando· Orlando, FL

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