The purpose of this study is to evaluate whether high-dose testosterone followed by targeted radioligand therapy (TRT) is effective in treating metastatic castration resistant prostate cancer. Participants will be asked to spend about 6 months in this study. Participants will take study drug for 3.5 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
IM injection of Tc at 400 mg (Tc400) every 28 days for up to 3 doses.
Continuing ADT with either surgical castration or chemical castration with LHRH analog is considered standard of care for mCRPC.
IV at 7.4GBq (200mCi) once every 6 weeks for up to 6 doses.
Moffitt Cancer Center
Tampa, Florida, United States
RECRUITINGFeasibility of Tc400 and PSMA-617
Percentage of patients who can complete 3 doses of Tc400 followed by at least 2 doses of PSMA-617.
Time frame: Up To 6 Months
Reduction in P/T ratio
Percentage of evaluable patients with 50% reduction in P/T ratio (PT50) compared to baseline P/T ratio based on PSA and testosterone values at screening.
Time frame: Up To 6 Months
PSA50 and PSA 90
Percentage of patients who achieved PSA50 and PSA 90 responses after two doses of PSMA-617 compared to the pre PSMA-617 PSA values at day 60.
Time frame: Up To 6 Months
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