Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC

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.

Trial Details

NCT ID
NCT07476001
Phase
PHASE2
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Testosterone cypionate (Tc)
  • ADT with Luteinizing hormone-releasing hormone (LHRH) analog
  • PSMA-617
Locations (sample)
  • Tampa, Florida, United States|27.94752,-82.45843

Key Eligibility Criteria

  • Participants must have histologically or cytologically confirmed prostate cancer that has progressed to mCRPC with no grade 2 or above cancer relat…
  • Participants need to have either PSA or imaging progression at castrate level of serum testosterone (i.e. \<50ng/dl). The definition of PSA progres…
  • Participants need to have a positive PSMA PET scan and deem eligible for PSMA-617.
  • Allowable prior therapies: Prior treatment with one line of ARPI. Patients need to be on ARPI for at least 4 weeks to be considered one line of the…

For full eligibility, visit ClinicalTrials.gov.

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