A Phase 2a Study of High Dose Testosterone Followed by Targeted Radioligand Therapy in Metastatic Castration Resistant Prostate Cancer
H. Lee Moffitt Cancer Center and Research Institute
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have histologically or cytologically confirmed prostate cancer that has progressed to mCRPC with no grade 2 or above cancer related symptoms. * Participants need to have either PSA or imaging progression at castrate level of serum testosterone (i.e. \<50ng/dl). The definition of PSA progression and the definitions of imaging progression on measurable or non-measurable lesions will be based on the prostate cancer working group 3 (PCWG3) criteria. Patients with symptomatic oligo progression (1-3 sites), the symptoms need to be improved to grade 1 or less…
Interventions
- DrugTestosterone cypionate (Tc)
IM injection of Tc at 400 mg (Tc400) every 28 days for up to 3 doses.
- DrugADT with Luteinizing hormone-releasing hormone (LHRH) analog
Continuing ADT with either surgical castration or chemical castration with LHRH analog is considered standard of care for mCRPC.
- DrugPSMA-617
IV at 7.4GBq (200mCi) once every 6 weeks for up to 6 doses.
Location
- Moffitt Cancer CenterTampa, Florida