Phase I Study of 225Ac-J591 Plus 177Lu-PSMA Small Molecule for Progressive Metastatic Castration Resistant Prostate Cancer
About This Trial
- This early-stage clinical trial is testing a combination of two targeted radiation drugs designed to seek out and attack prostate cancer cells.
- The main goal of the study is to determine the highest dose of this combined therapy that patients can receive safely without severe side effects.
- It is designed for adults with advanced prostate cancer that has spread to other parts of the body and continues to grow despite prior treatments, such as hormone therapy and chemotherapy.
- Before considering this trial, patients should know that it is a safety-focused study rather than a proven treatment, and participants must have adequate kidney, liver, and bone marrow function to qualify.
More Information
- This is a phase I dose-escalation study of 225Ac-J591 administered together with 177Lu-PSMA small molecule.
- Both drugs are designed to deliver radiation to prostate cancer cells; they are known as radionuclide conjugates (radiation linked to antibodies/molecules that recognize prostate cancer cells).
- This phase of the study (phase I) will determine the highest dose of the study intervention that can be safely given.
Who Can Enroll
- Age Range: 18 - 99 years
- Gender: Male
- Who This Trial is For: This early-stage clinical trial is testing a combination of two targeted radiation drugs designed to seek out and attack prostate cancer cells.
Study Details
- Start Date: June 30, 2021
- Lead Sponsor: Weill Medical College of Cornell University
Full Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of prostate
- Documented progressive metastatic CRPC based on Prostate Cancer Working Group 3 (PCWG3) criteria, which includes at least one of the following criteria: PSA progression, Objective radiographic progression in soft tissue, New bone lesions
- ECOG performance status of 0-2
- Have serum testosterone 18 years
- Patients must have normal organ and marrow function as defined below: Absolute neutrophil count: >2,000 cells/mm3, Hemoglobin: ≥9 g/dL, Platelet count: >150,000 x 109/uL, Serum creatinine: <1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 by Cockcroft-Gault, Serum total bilirubin: <1.5 x ULN (unless due to Gilbert's syndrome in which case direct bilirubin must be normal), Serum AST and ALT: <1.5 x ULN in the absence of liver metastases; <3 x ULN if due to liver metastases (in both circumstances bilirubin must meet entry criteria)
- Ability to understand, and the willingness to sign, a written informed consent document
Exclusion Criteria
- Implantation of investigational medical device ≤4 weeks of Treatment visit #1 (Day
- or current enrollment in oncologic investigational drug or device study
- Use of investigational drugs ≤4 weeks or 2 weeks
Treatments
- Drug: 225Ac-J591
- Drug: 177Lu-PSMA-617
- Drug: 68Ga-PSMA-11
- Drug: 177Lu-PSMA-I&T