Active — Not RecruitingPhase 3

177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer

United States469 participantsStarted 2021-06-15

Plain-language summary

The purpose of this study is to determine whether 177Lu-PSMA-617 improves the Radiographic progression-free survival (rPFS) or Overall Survival (OS) compared to a change in Androgen receptor-directed therapy (ARDT) in metastatic castrate resistant prostate cancer (mCRPC) participants that were previously treated with an alternate ARDT and not exposed to a taxane-containing regimen in the CRPC or mHSPC settings. 469 participants were randomized (235 in the 177Lu-PSMA-617 group and 234 in the ARDT group.

Who can participate

Age range18 Years – 100 Years

SexMALE

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Exclusion criteria

✕. Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological therapy, or investigational therapy.

What they're measuring

Radiographic Progression Free Survival (rPFS)

Timeframe: median FU (randomization to event or censoring) 3.65 months (range 0-12.3)

Trial details

NCT IDNCT04689828

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-02

Results submitted2025-04-28

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