Re-treatment 225Ac-J591 for mCRPC

Completed · Early Phase 1

Conditions studied: Prostate Cancer

In brief

The purpose of this study is to find out if re-treatment with 225Ac-J591 can be given without severe side effects.

Key facts

Study ID: NCT04576871
Run by: Weill Medical College of Cornell University
People needed: 6
Starts: 2020-10-29
Expected to finish: 2024-05-31
Last updated by the study team: 2025-08-28

Who can join

Age: 18 and older, up to 99. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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 ≤ 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH/GnRH analogue (agonist/antagonist) if they have not undergone orchiectomy
Have previously been treated with at least one of the following in any disease state:
Androgen receptor signaling inhibitor (such as enzalutamide)
CYP 17 inhibitor (such as abiraterone acetate)
Have previously received taxane chemotherapy (in any disease state), been determined to be ineligible for taxane chemotherapy by their physician, or refused taxane chemotherapy
Age ≥ 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 x 10\^3/ microliter
Serum creatinine: ≤1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min/1.73 m\^2 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 ≤3 x ULN in absence of liver metastases; < 5x 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
In the opinion of the investigator, history of clinical benefit with treatment using PSMA-TRT and no dose-limiting toxicity. Clinical benefit might be assessed by PSA changes, CTC changes, radiographic changes, and/or symptomatic improvement

You may not qualify if…

Implantation of investigational medical device ≤4 weeks of Treatment Visit 1 (Day 1) or current enrollment in oncologic investigational drug or device study
Use of investigational drugs ≤4 weeks or <5 half-lives of Cycle 1, Day 1 or current enrollment in investigational oncology drug or device study
Prior systemic bone-seeking beta-emitting radioisotopes. Prior radium-223 is allowed provided last dose was at least 12 weeks prior to C1D1 on this protocol
History of deep vein thrombosis and/or pulmonary embolus within 1 month of C1D1
Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
Radiation therapy ≤4 weeks of Day 1 Cycle 1
Having partners of childbearing potential and not willing to use a method of birth control deemed acceptable by the principle investigator and chairperson during the study and for 1 month after last study drug administration
Currently active other malignancy other than non-melanoma skin cancer. Patients are considered not to have "currently active" malignancy if they have completed any necessary therapy and are considered by their physician to be at less than 30% risk of relapse
Known history of known myelodysplastic syndrome

Where it is running

Brooklyn Methodist Hospital - New York Presbyterian — Brooklyn, New York, United States
Weill Cornell Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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