Prostate Cancer Clinical Trial
Official title:
Pilot Study of PSMA-TRT Re-treatment Utilizing 225Ac-J591
The purpose of this study is to find out if re-treatment with 225Ac-J591 can be given without severe side effects.
Status | Recruiting |
Enrollment | 18 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria 1. Histologically or cytologically confirmed adenocarcinoma of prostate 2. 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 3. ECOG performance status of 0-2 4. 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 5. 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) 6. Have previously received taxane chemotherapy (in any disease state), been determined to be ineligible for taxane chemotherapy by their physician, or refused taxane chemotherapy 7. Age = 18 years 8. 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) 9. Ability to understand and the willingness to sign a written informed consent document 10. 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 Exclusion Criteria 1. Implantation of investigational medical device =4 weeks of Treatment Visit 1 (Day 1) or current enrollment in oncologic investigational drug or device study 2. 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 3. 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 4. History of deep vein thrombosis and/or pulmonary embolus within 1 month of C1D1 5. 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 6. Radiation therapy =4 weeks of Day 1 Cycle 1 7. 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 8. 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 9. Known history of known myelodysplastic syndrome |
Country | Name | City | State |
---|---|---|---|
United States | Brooklyn Methodist Hospital - New York Presbyterian | Brooklyn | New York |
United States | Weill Cornell Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the proportion of subjects in assessing safety of 225Ac-J591 in those previously treated with PSMA-TRT. | Proportion of subjects with dose-limiting toxicity (DLT) from treatment cycle 1 to the end of the safety evaluation period at the end of the study. Acceptable safety is determined if no more than 2 (33%) of the subjects in a cohort experience DLT. | Will be collected at the time of visit 1 through end of study or 100 months | |
Secondary | Change in the number of subject with Prostate Specific Antigen (PSA) decline following 225Ac-J591 administration | PSA will be analyzed through blood specimen collection | Will be collected at the time of visit 1 through end of study or 100 months | |
Secondary | Change in adverse event rate response | National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 is used to grade all adverse events | Will be collected at the time of visit 1 through end of study or 100 months | |
Secondary | Change in the number of subjects with dose limiting toxicity (DLT) | DLTs will be measured by the recommended phase I fractionated dose and multiple dose regimens of 225Ac-J591 dose by utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | Will be collected at the time of visit 1 through end of study or 100 months | |
Secondary | Change in radiographic response rate | Radiographic response rate will be captured through radiographic scans such as MRI, CT and bone scans. Response evaluation criteria in solid tumors (RECIST) criteria with Prostate Cancer Working Group 3 (PCWG3) modifications | Will be collected at the time of visit 1 through end of study or 100 months | |
Secondary | Change in circulating tumor cells (CTC) response | CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing | Will be collected at the time of visit 1 through end of study or 100 months | |
Secondary | Change in progression-free survival following re-treatment doses of 225Ac-J591 | Will be collected at the time of visit 1 through end of study or 100 months | ||
Secondary | Change in Overall Survival Following re-Treatment Doses of 225Ac-J591 | Overall survival will be captured through in-clinic or telephone contact with subjects | Survival will be collected at the time of visit 1 through end of study or 100 months |
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