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Phase I/II Study of ADI-PEG20 with Chemotherapy for Aggressive Prostate Cancer

This study is looking for men with aggressive variant prostate cancer (AVPC) to test a new combination of treatments. It combines ADI-PEG20 (a drug given by injection) with two chemotherapy drugs, Cabazitaxel and Carboplatin (both given by IV). The main goal is to find the safest and most effective dose of ADI-PEG20 when given with these chemotherapies. Researchers will also look at how well the treatment shrinks tumors and how long patients live without their cancer getting worse. They will also study certain biomarkers (like PTEN and TP53) and how the treatment affects the immune system. The study is currently enrolling 30 participants.

Study design
This is an interventional study planning to enroll 30 male participants aged 18 and older with prostate cancer. It is a Phase I/II study, meaning it will first look for the best dose and then evaluate the treatment's effects.
What's involved
You would need to complete an informed consent process and agree to provide tissue samples for research at specific times. You must also consent to a specific laboratory protocol.
Compensation
Not stated in the trial record.
Follow-up
The incidence of side effects will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06085729

Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~30 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:ADI-PEG 20CabazitaxelCarboplatin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured over Through study completion; an average of 1 year.

Conditions

Prostate Cancer

Explore related trials

Prostate CarcinomaPTEN GeneRB1 GeneTP53 Gene

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Ana Aparicio, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Ana Aparicio, MD
[email protected]
(713) 563-6969
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

AVPC determination by immunohistochemistry. Tumor samples are considered negative (and thus abnormal) for RB1 and PTEN if their labeling index is ≤ 10% and positive (and thus aberrant) for Tp53 if their labeling index is ≥ 10%, where the labeling index is defined as the percentage of positive cells, and calculated as the number of positively stained epithelial cells divided by the total number of epithelial cells, at X200 magnification.
AVPC determination by DNA sequencing. The TP53, RB1 and PTEN genes will be considered aberrant if they contain exonic nonsynonymous missense or stop-gain mutations, frameshift or non-frameshift indels (insertions or deletions), and/or copy number losses.

What this trial measures

  • Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0Through study completion; an average of 1 year.