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)
A Phase I, Open-label, Multi-center Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: University of California LA — Los Angeles, California
Age range: 18 Years to 100 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (21 Sites)
- University of California LA — Los Angeles, California
- Stanford University — Palo Alto, California
- Mayo Clinic Rochester — Rochester, Minnesota
- Wash U School of Medicine — St Louis, Missouri
- Nebraska Cancer Specialists — Omaha, Nebraska
- Novartis Investigative Site — Cologne, North Rhine-Westphalia
- Novartis Investigative Site — Wuppertal, North Rhine-Westphalia
- Novartis Investigative Site — Aachen,
- Novartis Investigative Site — Berlin,
- Novartis Investigative Site — Essen,
- Novartis Investigative Site — München,
- Novartis Investigative Site — Rostock,
- Novartis Investigative Site — Nijmegen, Gelderland
- Novartis Investigative Site — Santiago Compostela, A Coruna
- Novartis Investigative Site — Majadahonda, Madrid
- Novartis Investigative Site — Barcelona,
- Novartis Investigative Site — Bellinzona,
- Novartis Investigative Site — Bern,
- Novartis Investigative Site — Sutton, Surrey
- Novartis Investigative Site — Birmingham, West Midlands
- Novartis Investigative Site — Glasgow,
📞 Contact the Study Coordinator
Phone: (888) 669-6682
Email: novartis.email@novartis.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metastatic Castration-Resistant Prostate Cancer
- A Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer — San Francisco, California
- Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment — Tucson, Arizona
- ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC — Sacramento, California
- FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) — Duarte, California
- A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer — Duarte, California
- FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer — San Francisco, California
Explore by condition: All Metastatic Castration-Resistant Prostate Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.