The purpose of this study is to evaluate the safety of combining Actinium- J591 with radiation therapy or with androgen deprivation therapy.
This is a two cohort pilot study for patients with hormone-sensitive prostate cancer after primary treatment +/- salvage treatment with metastases detected on PSMA-PET scan but equivocal, indeterminate or absent on conventional imaging. Cohort 1 will have patients with Oligometastatic (low volume, between 1 and 5 metastases) disease and Cohort 2 will have patients with polymetastatic (high volume, ≥5 metastases) disease detected via PSMA PET.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Cohort 1 with oligometastatic disease will receive Actinium-J591 and Stereotactic Body Radiation Therapy
Cohort 1 patients with oligometastatic disease will receive Actinium-J591 and Stereotactic Body Radiation Therapy
Cohort 2 patient with Polymetastatic disease will receive Actinium-J591 and Androgen Deprivation therapy (ADT)
Dose Limiting Toxicity (DLT) Rate
A DLT will is defined as a grade 3 or higher hematologic adverse event or a grade 2 or higher non-hematologic adverse event deemed to be at least possibly related to study treatment. Adverse events will be assessed using CTCAE version 5. Patients will be observed for a DLT for 3 months from the second dose of actinium-J591.
Time frame: 24 months
Change in Maximum Tolerated Dose (MTD)
Time frame: 3,6,12,18 and 24 months.
Progression Free Survival (PFS) on conventional Imaging
Time frame: 3 months
Progression Free Survival (PFS) on conventional Imaging
Time frame: 6 months
Progression Free Survival (PFS) on conventional Imaging
Time frame: 12 months
Progression Free Survival (PFS) on conventional Imaging
Time frame: 24 months
Progression Free Survival (PFS) on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging.
Time frame: 3 months
Progression Free Survival (PFS) on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging.
Time frame: 6 months
Progression Free Survival (PFS) on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging.
Time frame: 12 months
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Progression Free Survival (PFS) on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging.
Time frame: 24 months
Changes in PSMA expression measured by comparison of SUV on PSMA PET scans before and after treatment
Time frame: 3, 6, 12, and 24 months
Change in Percentage of PSA decline
Time frame: 3, 6, 12, 15, 18, 21, and 24 months.