Neoadjuvant Listeria or Daratumumab in Prostate Cancer

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03035357
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Daratumumab — DRUG
    16 mg/kg by vein once weekly for a total of 4 doses.

Study Details

The goal of this clinical research study is to learn about biomarker changes in patients who have primary prostate cancer after receiving Darzalex (daratumumab) and then have a prostatectomy (the surgical removal of the prostate) as part of their standard care. Biomarkers are found in the blood/tissue and may be related to your reaction to the study drug.

Key Dates

Start date
Mar 1, 2017
Status verified
May 2024
Primary completion
Mar 1, 2019
Completion
Mar 1, 2019

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Daratumumab
    Participants receive Daratumumab by vein over about 1 hour 1 time a week during Weeks 1-4.

Primary Outcome Measure

Biomarker Response of CD3 and CD68 Following Treatment with Daratumumab. [ Time Frame: Baseline and at 12 weeks after prostatectomy ]

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