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New treatment option for Prostate Cancer
Official title Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)
ClinicalTrials.gov ID: NCT06085729
What this study is testing
What is ADI-PEG 20?
ADI-PEG 20 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To find the best dose of ADI-PEG20 that can be given in combination with carboplatin and cabazitaxel to patients with AVPC.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Completion of informed consent prior to any study specific procedures.
- Patients must agree to tissue collection for correlative studies at the specified timepoints.
- Patients must consent to the MD Anderson Immunotherapy Platform laboratory protocol PA13-0291.
- Male aged 18 years and above.
- Histologically or cytologically confirmed prostate carcinoma.
You likely can't join if
- Any prior treatment for CRPC with carboplatin, cisplatin or cabazitaxel.
- Patients who have received more than one line of chemotherapy for prostate cancer. Any number of prior hormonal or targeted therapies are allowed.
- Patients who have not recovered from adverse events secondary to systemic therapy (except for LHRH agonist or antagonist treatment for prostate...
- Any unresolved toxicity (CTCAE Grade ≥2) from previous anti-cancer therapy. people with irreversible toxicity that is not reasonably expected to be...
- Active uncontrolled infection (patients completing a course of antibiotic or antiviral therapy whose infection is deemed to be controlled may be...
- Active or symptomatic viral hepatitis or chronic liver disease.
See the full eligibility criteria
- Completion of informed consent prior to any study specific procedures.
- Patients must agree to tissue collection for correlative studies at the specified timepoints.
- Patients must consent to the MD Anderson Immunotherapy Platform laboratory protocol PA13-0291.
- Male aged 18 years and above.
- Histologically or cytologically confirmed prostate carcinoma.
- Presence of metastatic disease documented on imaging studies (bone scan, CT and/or MRI scans).
- Patients must meet at least one of the following AVPC criteria: i. Histologically proven small cell (neuroendocrine) prostate carcinoma ii. Exclusive visceral metastases. iii. Predominantly lytic bone metastases...
- 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...
- 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...
- Patients must have documented evidence of progressive disease as defined by any of the following: I. PSA progression: minimum of 2 rising values (3 measurements) obtained a minimum of 7 days apart with the last result...
- Surgically or ongoing medically castrated, with baseline testosterone levels of ≤ 50 ng/dL (≤2.0 nM). Exception: Patients with de novo primary small cell carcinoma of the prostate may begin chemotherapy on study once...
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
- Patients must have adequate organ and bone marrow function measured within 7 days prior to treatment registration as defined below: I. Hemoglobin ≥ 9.0 g/dL (unless deemed by the treating physician to be due to bone...
- Patients who have partners of childbearing potential (e.g., female that has not been surgically sterilized or who are not amenorrheic for ≥ 12 months) must be willing to use a method of birth control in addition to...
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Any prior treatment for CRPC with carboplatin, cisplatin or cabazitaxel.
- Patients who have received more than one line of chemotherapy for prostate cancer. Any number of prior hormonal or targeted therapies are allowed.
- Patients who have not recovered from adverse events secondary to systemic therapy (except for LHRH agonist or antagonist treatment for prostate cancer, and bisphosphonates or RANK ligand inhibitors for bone...
- Any unresolved toxicity (CTCAE Grade ≥2) from previous anti-cancer therapy. people with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g...
- Active uncontrolled infection (patients completing a course of antibiotic or antiviral therapy whose infection is deemed to be controlled may be allowed on study after discussion with the PI; the PI will serve as the...
- Active or symptomatic viral hepatitis or chronic liver disease.
- A history of extensive bilateral lung disease of non-malignant etiology.
- A malignancy [other than the one treated in this study] which has a '≥ 30% probability of recurrence within 24 months (except for adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the...
- Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events. Examples: include, but are...
- Patients with symptomatic uncontrolled brain metastases or spinal cord compressions. A scan to confirm the absence of brain metastases is not required.
- Prisoners or people who are involuntarily incarcerated.
- people who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ADI-PEG 20, pegylated compounds, or other agents used in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.