Metastatic Prostate Cancer, Metastatic Prostate Carcinoma in the Soft Tissue, Metastatic Prostatic Adenocarcinoma, Prostate Adenocarcinoma, Prostate Cancer, Prostatic Neoplasms
Conditions
Keywords
Radioligand therapy, PSMA, PSMA therapy, 1095
Brief summary
Single-arm, open-label, phase II trial in 200 competent adult male patients with Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-3 and progressive metastatic prostate cancer, failing, failed, refused, not eligible for or no access to further approved lines of therapy. Patients will undergo sequential FDG positron emission tomography (PET) and 18F-DCFPyL PET to assess FDG/DCFPyL concordance fraction. Patients with DCFPyL/FDG concordance of 50% or greater will be treated with 131I-PSMA-1095 radioligand therapy (RLT). Best post-treatment serum prostate specific antigen response will be compared to concordance fraction.
Interventions
DRUG131I-PSMA-1095 Radioligand Therapy (RLT)
Intravenous injection of 100 mCi of 131I-PSMA-1095, Q8 weeks up to a maximum of 4 doses.
Sponsors
Sir Mortimer B. Davis - Jewish General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male * Age 18 years or older * Documented metastatic adenocarcinoma of the prostate * Under active medical oncology care * ECOG performance status 0 - 3, inclusive * Able to understand and provide written informed consent * Able to tolerate the physical requirements of two PET/CT scans including lying for up to 30 minutes * Progressive disease on any of: bone scan, CT, MRI or serum PSA as judged by the investigator * Serum prostate specific antigen ≥ 1 ng/ml at baseline or CT/MRI soft-tissue measurable disease as per RECIST v1.1 * Failed, failing, refused, no access to or not eligible for any approved prostate cancer therapies including but not limited to: ADT, NAAD (e.g., abiraterone, enzalutamide, darolutamide or apalutamide), docetaxel, cabazitaxel, radium-223 and oligometastatic RTX * Life expectancy of at least 3 months as judged by the investigator
Exclusion criteria
* Medically unstable (e.g. acute cardiac or respiratory distress or hypotensive) * Exceeding the weight limit of the PET/CT bed (approximately 400 lbs.) or who cannot fit through the PET/CT bore (approximately 70 cm diameter) * Unmanageable claustrophobia * Prior failure of PSMA RLT * Prior hemi-body irradiation * Impaired organ function as evidenced by any of the following laboratory values: * Absolute neutrophil count \< 1.5 x109/L * Platelet count \< 75 x109/L * Hemoglobin \< 85 g/L * Albumin \< 2.5 g/dL (25 g/L) * Total bilirubin \> 2 x ULN (unless in instances of Gilbert's disease) * AST or ALT \> 2.5 x ULN (or \> 5.0 x ULN in the presence of liver metastases)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum prostate specific antigen (PSA) | 3 months post last dose of RLT | The best serum prostate specific antigen (PSA) response will be calculated for each patient as: pre-treatment PSA minus lowest post-treatment PSA divided by pre-treatment PSA. Best PSA response will be reported as percent reduction (or increase) from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 3 months post last dose of RLT | Frequency of adverse events in participants receiving therapy as per CTCAE v5.0 |
Countries
Canada
Outcome results
None listed