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
Recruiting now · Phase 1
Conditions studied: Metastatic Castration-Resistant Prostate Cancer
In brief
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).
Key facts
- Study ID
- NCT06531499
- Run by
- Novartis Pharmaceuticals
- People needed
- 106
- Starts
- 2024-11-11
- Expected to finish
- 2028-11-24
- Last updated by the study team
- 2025-12-31
Who can join
Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.
Where it is running
- University of California LA — Los Angeles, California, United States (enrolling)
- Stanford University — Palo Alto, California, United States (enrolling)
- Mayo Clinic Rochester — Rochester, Minnesota, United States (enrolling)
- Wash U School of Medicine — St Louis, Missouri, United States (enrolling)
- Nebraska Cancer Specialists — Omaha, Nebraska, United States (enrolling)
- Novartis Investigative Site — Cologne, North Rhine-Westphalia, Germany (enrolling)
- Novartis Investigative Site — Wuppertal, North Rhine-Westphalia, Germany (enrolling)
- Novartis Investigative Site — Aachen, Germany (enrolling)
- Novartis Investigative Site — Berlin, Germany (enrolling)
- Novartis Investigative Site — Essen, Germany (enrolling)
- Novartis Investigative Site — München, Germany (enrolling)
- Novartis Investigative Site — Rostock, Germany (enrolling)
- Novartis Investigative Site — Nijmegen, Gelderland, Netherlands (enrolling)
- Novartis Investigative Site — Santiago Compostela, A Coruna, Spain (enrolling)
- Novartis Investigative Site — Majadahonda, Madrid, Spain (enrolling)
- Novartis Investigative Site — Barcelona, Spain (enrolling)
- Novartis Investigative Site — Bellinzona, Switzerland (enrolling)
- Novartis Investigative Site — Bern, Switzerland (enrolling)
- Novartis Investigative Site — Sutton, Surrey, United Kingdom (enrolling)
- Novartis Investigative Site — Birmingham, West Midlands, United Kingdom (enrolling)
- Novartis Investigative Site — Glasgow, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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