About this trial
The goal of this clinical research study is to determine how well a tirzepatide-assisted weight loss program works before a prostatectomy in patients with intermediate risk prostate cancer
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical T2b-T2c or lower disease
Gleason Grade group 2 or 3 on biopsy
PSA ≤20 ng/mL
Desires radical prostatectomy (open or robotic) for prostate cancer management and is a surgical candidate as determined by the treating urologic oncologist
Disqualifiers
pT3a or higher disease
Grade group 4 or 5 adenocarcinoma of prostate
Presence of metastatic disease on imaging
A history of intentional or unintentional weight loss of more than 5kg within 90 days of screening
Trial design
Single group
Treatments tested in this trial
Tirzepatide
DrugParticipants will perform weekly self-injection of tirzepatide as standard of care, following manufacturer instructions
Treatment groups
Trial outcomes
Primary outcomes
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Sponsors and contacts
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