USO 23047
An International, Prospective, Open-label, Multi-center, Randomized Phase III Study comparing lutetium (177Lu) vipivotide tetraxetan versus Observation to delay castration or disease recurrence in adult male patients with prostate-specific membrane antigen (PSMA) positive Oligometastatic Prostate Cancer (OMPC) (CAAA617D12302)
Disease Types: Genitourinary Cancer Research
Eligibility Requirements:
- Signed informed consent must be obtained prior to participation in the study
- Participants must be adults >18 years of age at the time of informed consent
- ECOG performance status of 0 or 1 at screening
- Participants must have a life expectancy >24 months as determined by the Investigator at screening
- Histologically confirmed prostate cancer prior to randomization
- Participants must have biochemically recurrent disease after definitive treatment to prostate by RP, (alone or with post-operative radiation to prostate bed/pelvic nodes) or XRT, (prostate alone or prostate with seminal vesicle and/or pelvic nodes) and/or brachytherapy prior to randomization. Biochemical recurrence is defined as: nadir PSA + 2 ng/mL post XRT (if participant received-radiation therapy to intact prostate) and PSA > 0.2 ng/mL and rising post RP (with or without post-operation RT)
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