Pre-Surgical Tirzepatide-Assisted Weight Loss in Overweight and Obese Men With Intermediate Risk Prostate Cancer: A Pilot Feasibility Study

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorM.D. Anderson Cancer Center

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Tirzepatide

    Drug

    Participants will perform weekly self-injection of tirzepatide as standard of care, following manufacturer instructions

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: TirzepatideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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