Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer

Conditions
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Prostate Cancer, Prostate Adenocarcinoma, Prostatic Neoplasms, Metastatic Prostate Cancer, Metastatic Prostatic Adenocarcinoma, Metastatic Prostate Carcinoma in the Soft Tissue

Intervention / Treatment
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* Drug: 131I-PSMA-1095 Radioligand Therapy (RLT)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 131I-PSMA-1095 Radioligand Therapy (RLT)<br>Intravenous injection of 100 mCi of 131I-PSMA-1095 RLT, Q8 weeks up to a maximum of 4 doses | Drug: 131I-PSMA-1095 Radioligand Therapy (RLT)<br>* Intravenous injection of 100 mCi of 131I-PSMA-1095, Q8 weeks up to a maximum of 4 doses.<br>* Other names: PSMA RLT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum prostate specific antigen (PSA) | 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. | 3 months post last dose of RLT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Frequency of adverse events in participants receiving therapy as per CTCAE v5.0 | 3 months post last dose of RLT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radioligand therapy, PSMA, PSMA therapy, 1095