Prostate Cancer Clinical Trial
Official title:
Phase I Dose-Escalation Trial of 225Ac-J591 in Patients With Metastatic Castration-Resistant Prostate Cancer
Verified date | October 2023 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an open-label, single-center Phase I dose escalation study designed to determine the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) of 225Ac-J591 in a single dose regimen.
Status | Completed |
Enrollment | 32 |
Est. completion date | September 1, 2023 |
Est. primary completion date | January 7, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
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: 1. PSA progression 2. Objective radiographic progression in soft tissue 3. 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 analogue (agonist/antagonist) if they have not undergone bilateral orchiectomy. 5. Have previously been treated with at least one of the following: 1. Androgen receptor signaling inhibitor (such as enzalutamide) 2. CYP 17 inhibitor (such as abiraterone acetate) 6. Have previously received taxane chemotherapy, 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: 1. Absolute neutrophil count >2,000 cells/mm3 2. Hemoglobin =9 g/dL 3. Platelet count >150,000 x 109/microliter 4. Serum creatinine <1.5 x upper limit of normal (ULN) or calculated creatinine clearance = 60 mL/min/1.73 m2 by Cockcroft-Gault 5. Serum total bilirubin <1.5 x ULN (unless due to Gilbert's syndrome in which case direct bilirubin must be normal 6. 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. Exclusion Criteria: 1. Implantation of investigational medical device =4 weeks of Cycle 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 beta-emitting bone-seeking radioisotopes 4. Known active brain metastases or leptomeningeal disease 5. History of deep vein thrombosis and/or pulmonary embolus within 1 month of C1D1 6. 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 7. Radiation therapy for treatment of PC =4 weeks of Day 1 Cycle 1 8. Patients on stable dose of bisphosphonates or Denosumab, which have been started no less than 4 weeks prior to treatment start, may continue on this medication, however patients are not allowed to initiate bisphosphonate/Denosumab therapy during the DLT-assessment period of the study. 9. 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 10. 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. 11. Known history of known myelodysplastic syndrome |
Country | Name | City | State |
---|---|---|---|
United States | Tulane Cancer Center Clinic | New Orleans | Louisiana |
United States | Weill Cornell Medical College | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | National Cancer Institute (NCI), National Institutes of Health (NIH), Prostate Cancer Foundation, United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects With Dose Limiting Toxicities (DLT) | Count of participants will be measured by the recommended phase II dose in utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for DLTs. | Assessed from start of treatment to up to 8 weeks after first study drug administration. | |
Primary | Number of Subjects Who Reached Maximum Tolerated Dose (MTD) | The MTD is the highest dose amongst the different dose-level cohorts in this study at which no more than 2 (33%) of the subjects in a cohort experience DLT. | Assessed from start of treatment to up to 8 weeks after first study drug administration. | |
Secondary | Number of Subjects With Prostate Specific Antigen (PSA) Response | PSA will be analyzed through blood specimen collection | PSA was assessed at screening, and up to 6 months after first treatment with study drug. | |
Secondary | Number of Subjects With Circulating Tumor Cells (CTC) Response | CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing | CTC was assessed at screening and 12 weeks after starting study drug. | |
Secondary | Number of Subjects With Radiographic (Imaging) Response | Radiographic response rate by Response evaluation criteria in solid tumors (RECIST) criteria with Prostate Cancer Working Group 3 (PCWG3) modifications | Response were assessed for patients throughout their duration on the study, up to 3 years. | |
Secondary | Progression Free Survival (PFS) | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | From the start of treatment to progression, up to 3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Active, not recruiting |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |