medcelerator · clinician one-pager
New Radiation Treatment for Hormone-Sensitive Metastatic Prostate Cancer
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) — targeted radiation given with hormone-pathway pills for metastatic prostate cancer that still responds to hormone therapy
FDA Approved · United States · September 11, 2026
Condition: Prostate Cancer
Who this is for
This is for adults with metastatic prostate cancer that still responds to hormone-pathway therapy, whose tumors light up on a PSMA PET scan, and who may be candidates for labelled US Pluvicto given with a hormone-pathway pill and ongoing androgen-deprivation therapy. It explains the July 2026 FDA expansion, the PSMAddition delay-in-progression numbers, radiation / blood-count / kidney watchpoints, Novartis Patient Support, and how to talk with a prostate-cancer / nuclear-medicine team — without treating overall survival as already proven, mixing this earlier pathway with the older castration-resistant label, a DIY import as a plan, or “approved” as funded. Authorized is not funded.
Next clinical step
The US Food and Drug Administration (FDA) has approved this medicine. In the United States, ask your doctor or a specialist whether it suits you. They can write a prescription. Insurance or public drug plan coverage is not guaranteed.
Ways to access this treatment
United States · Prescription
US prescription (FDA-labelled)
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutetium-lu-177-vipivotide-tetraxetan-androgen-receptor-pathway-inhibitor-therapy
United States · Recruiting clinical trial
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial
Tests this treatment. Pluvicto dosing schedules in metastatic prostate cancer (phase 3).
https://clinicaltrials.gov/study/NCT07200830
United States · Recruiting clinical trial
Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)
Tests this treatment. Flexible dosing schedule of Lu-PSMA-617 in mCRPC (phase 2).
https://clinicaltrials.gov/study/NCT06216249
United States · Recruiting clinical trial
Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer
Combination or different setting. Tests abemaciclib before Lu-PSMA-617 (phase 1/2).
https://clinicaltrials.gov/study/NCT05113537
Search all trials on ClinicalTrials.gov: https://clinicaltrials.gov/search?cond=prostate%20cancer&intr=lutetium%20Lu%20177%20vipivotide%20tetraxetan&aggFilters=status:rec
Possible routes (not confirmed)
United States · Not yet recruiting clinical trial · Applicability unknown
Pluvicto for the Treatment of African American Men With Metastatic Castration-Resistant Prostate Cancer
Trial not yet recruiting (ClinicalTrials.gov status: not yet taking patients).
https://clinicaltrials.gov/study/NCT07860554
United States · Not yet recruiting clinical trial · Applicability unknown
Escalating Cycle 1 Dose of Lu-177-PSMA-617 for the Treatment of Metastatic Castration Resistant Prostate Cancer
Trial not yet recruiting (ClinicalTrials.gov status: not yet taking patients).
https://clinicaltrials.gov/study/NCT07682649
General resources for further research
ClinicalTrials.gov
US National Library of Medicine registry of clinical studies. Search by condition, drug, NCT number, and location. A listing is not enrolment, eligibility, or funding. Talk with the trial contact and a clinician before assuming a slot exists.
https://clinicaltrials.gov/
AI-produced discussion aid; not prescribing instructions. Approval does not establish coverage. Full article: https://medcelerator.com/articles/pluvicto-lutetium-mapmns