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Compares treatment options for Metastatic Prostate Cancer
Official title Cabazitaxel +/- Carboplatin vs 177Lu-PSMA-617 in Metastatic Castrate-resistant Prostate Cancer
ClinicalTrials.gov ID: NCT06738303
What this study is testing
What is Cabazitaxel and carboplatin?
Cabazitaxel and carboplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic 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
- The purpose of this study is to find out what treatment works best for participants with metastatic prostate cancer that are not responding to hormone treatment and docetaxel and are also Prostate-specific membrane antigen(PSMA) positive.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- people must have histologically or cytologically confirmed metastatic castrate-resistant prostate cancer that has previously been treated with an...
- Participants must have a PSMA-positive 18F-rhPSMA-7.3 performed within 12 weeks from C1D1 with ≥1 site with SUVmax ≥10) mCRPC with progression on...
- PSMA SUV mean \<10
- ≥1 visceral metastasis
- ≥5 bone metastases OR two of the following
You likely can't join if
- Evidence of hormone-sensitive prostate cancer (HSPC)
- Evidence of small cell prostate cancer
- people receiving any other investigational agents.
- Diagnosis of another clinically significant malignancy within the previous 2 years other than curatively treated non-melanomatous skin cancer or...
- people with brain metastases/central nervous system (CNS) disease that are treated prior to enrollment will be allowed in this clinical trial.
- Known or suspected significant hypersensitivity to any components of the formulation used for Cabazitaxel, carboplatin or 177Lu-PSMA-617.
See the full eligibility criteria
- people must have histologically or cytologically confirmed metastatic castrate-resistant prostate cancer that has previously been treated with an androgen receptor pathway inhibitor. Prior docetaxel exposure is...
- Participants must have a PSMA-positive 18F-rhPSMA-7.3 performed within 12 weeks from C1D1 with ≥1 site with SUVmax ≥10) mCRPC with progression on prior novel hormonal agent to include at least one of the following:
- PSMA SUV mean \<10
- ≥1 visceral metastasis
- ≥5 bone metastases OR two of the following
- TP53
- PTEN
- RB1 mutation.
- Age \> 18 years.
- ECOG performance status of 0 to 2.
- people must have adequate organ and marrow function as defined below to be suitable for the assigned by chance treatment outlined in this:
- Absolute neutrophil count \>1000/μL; platelet count \>90 000/μL; hemoglobin \>8.5 g/dL) at screening. Note: people must not have received any growth factors within 7 days or blood transfusions within 14 days prior to...
- Total bilirubin (TBIL) \<2.5 × the upper limit of normal (ULN) at screening, except people with documented Gilbert syndrome who must have a TBIL \<3 mg/dL
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 5 ULN at screening
- Creatinine clearance ≥40 mL/min and/or estimated glomerular filtration rate (eGFR) ≥30
- Albumin \>30 g/L (3.0 g/dL) at screening
- people receiving bisphosphonates or other approved bone-targeting therapy (e.g., denosumab) must be on a stable dose for at least 14 days before the start of study treatment.
- people of child-producing potential agree to use highly effective contraceptive methods (i.e., barrier contraception measures such as a male condom with spermicide during intercourse) and avoid sperm donation during the...
- people must have the ability to understand and the willingness to sign a written informed consent form (ICF).
- Members of all races and ethnic groups are eligible for this trial.
- Evidence of hormone-sensitive prostate cancer (HSPC)
- Evidence of small cell prostate cancer
- people receiving any other investigational agents.
- Diagnosis of another clinically significant malignancy within the previous 2 years other than curatively treated non-melanomatous skin cancer or superficial urothelial carcinoma and other in situ or noninvasive...
- people with brain metastases/central nervous system (CNS) disease that are treated prior to enrollment will be allowed in this clinical trial.
- Known or suspected significant hypersensitivity to any components of the formulation used for Cabazitaxel, carboplatin or 177Lu-PSMA-617.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Prior treatment toxicities not resolved to ≤ Grade 2 according to NCI CTCAE Version 5.0
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, 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 all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, 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.