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
NCT06531499
This study is recruiting at 5 US sites in 4 states, according to its ClinicalTrials.gov record last updated .
Summary
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).
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Metastatic Castration-Resistant Prostate Cancer
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 1
- Ages
- 18 to 100 years
- Sex
- Male
- Healthy volunteers
- Not accepted
- Sponsor
- Novartis Pharmaceuticals
- Last updated on ClinicalTrials.gov
- December 31, 2025
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 2
- University of California LA · Los Angeles, CA
- Stanford University · Palo Alto, CA
Minnesota · 1
- Mayo Clinic Rochester · Rochester, MN
Missouri · 1
- Wash U School of Medicine · St Louis, MO
Nebraska · 1
- Nebraska Cancer Specialists · Omaha, NE
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.