Actively Recruiting
Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)
Led by M.D. Anderson Cancer Center · Updated on 2026-04-02
30
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To find the best dose of ADI-PEG20 that can be given in combination with carboplatin and cabazitaxel to patients with AVPC.
CONDITIONS
Official Title
Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completion of informed consent before any study procedures
- Agreement to tissue collection for research at specified times
- Consent to the MD Anderson Immunotherapy Platform laboratory protocol PA13-0291
- Male aged 18 years or older
- Histologically or cytologically confirmed prostate carcinoma
- Metastatic disease shown by bone scan, CT, or MRI
- Meet at least one aggressive variant prostate cancer (AVPC) criterion including small cell carcinoma, exclusive visceral metastases, predominantly lytic bone metastases, bulky lymphadenopathy or tumor mass, low PSA with high bone metastases, elevated LDH or CEA, short interval to castration resistance, or specific gene mutations
- Evidence of progressive disease by PSA rise, new or growing tumors, positive bone scan, worsening symptoms, or biopsy showing small cell transformation
- Surgically or medically castrated with testosterone 64 50 ng/dL (exceptions for de novo small cell carcinoma with initiated hormone therapy)
- ECOG Performance Status 64 2
- Adequate organ and bone marrow function within 7 days before treatment
- Willingness to use birth control and avoid sperm donation if applicable
- Willingness and ability to follow the study protocol including treatments and visits
You will not qualify if you...
- Prior treatment for castration-resistant prostate cancer with carboplatin, cisplatin, or cabazitaxel
- More than one line of chemotherapy for prostate cancer received
- Not recovered from side effects of prior systemic therapy, major surgery, or radiotherapy to grade >2
- Unresolved toxicity grade >2 from previous anti-cancer therapy (except some irreversible toxicities)
- Active uncontrolled infection
- Active or symptomatic viral hepatitis or chronic liver disease
- History of extensive bilateral lung disease of non-cancer origin
- Other cancers with high risk (>30%) of recurrence within 24 months (except some treated skin or cervical cancers)
- Medical or psychiatric conditions making study treatment unsafe or complicating side effect assessment
- Symptomatic uncontrolled brain metastases or spinal cord compression
- Prisoners or involuntarily incarcerated individuals
- Compulsorily detained for psychiatric or physical illness
- History of allergic reactions to ADI-PEG20, pegylated compounds, or study agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Ana Aparicio, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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