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Study identifier: NCT06531499 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study

Condition: Metastatic Castration-Resistant Prostate Cancer  ·  Sponsor: Novartis Pharmaceuticals

PhasePhase 1
Planned participants106
Who can joinMale, 18 Years to 100 Years
Healthy volunteersNo

About this study

The purpose of the study is to assess and evaluate dosimetry, safety, and tolerability following administration of up to 12 cycles of (177Lu) vipivotide tetraxetan (also referred to as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617) in taxane-naïve adult participants with PSMA-positive mCRPC who progressed on a prior ARPI treatment with normal renal function or mild renal impairment (eGFR ≥ 60ml/min).

This description comes directly from the study's public registry record.

Talk to the study team

Novartis Pharmaceuticals  ·  1-888-669-6682  ·  novartis.email@novartis.com

Novartis Pharmaceuticals  ·  +41613241111

Always discuss trial participation with your own doctor first.

Locations (21)

University of California LALos Angeles, California, United StatesRecruiting
Stanford UniversityPalo Alto, California, United StatesRecruiting
Mayo Clinic RochesterRochester, Minnesota, United StatesRecruiting
Wash U School of MedicineSt Louis, Missouri, United StatesRecruiting
Nebraska Cancer SpecialistsOmaha, Nebraska, United StatesRecruiting
Novartis Investigative SiteCologne, North Rhine-Westphalia, GermanyRecruiting
Novartis Investigative SiteWuppertal, North Rhine-Westphalia, GermanyRecruiting
Novartis Investigative SiteAachen, GermanyRecruiting
Novartis Investigative SiteBerlin, GermanyRecruiting
Novartis Investigative SiteEssen, GermanyRecruiting
Novartis Investigative SiteMünchen, GermanyRecruiting
Novartis Investigative SiteRostock, GermanyRecruiting

+ 9 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06531499