An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. (NCT05939414)
An International, Prospective, Open-label, Multi-center, Randomized Phase III Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) Versus Observation to Delay Castration or Disease Recurrence in Adult Male Patients With Prostate-specific Membrane Antigen (PSMA) Positive Oligometastatic Prostate Cancer (OMPC)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).
Who can join: Review the eligibility criteria below.
Location: Highlands Oncology Group — Fayetteville, Arkansas
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 (144 Sites)
Showing the first 25 of 144 sites.
- Highlands Oncology Group — Fayetteville, Arkansas
- VA Greater LA Healthcare System — Los Angeles, California
- VA Palo Alto Health Care System — Palo Alto, California
- Stanford University — Palo Alto, California
- UCSF — San Francisco, California
- Rocky Mountain Cancer Centers — Denver, Colorado
- Cancer Specialists of North Florida — Jacksonville, Florida
- Woodlands Medical Specialists — Pensacola, Florida
- Piedmont Healthcare — Atlanta, Georgia
- University of Chicago — Chicago, Illinois
- The Cancer Institute of Alexian Brothers — Elk Grove, Illinois
- Unity Point Clinic — Des Moines, Iowa
- University of Kansas Hospital — Kansas City, Kansas
- Mary Bird Perkins Cancer Center — Baton Rouge, Louisiana
- East Jefferson Hospital — Metairie, Louisiana
- University of Maryland Medical Ctr — Baltimore, Maryland
- Johns Hopkins Kimmel Com Cancer Ctr — Baltimore, Maryland
- Dana Farber Cancer Institute — Boston, Massachusetts
- Beth Israel Deaconess Med Ctr — Boston, Massachusetts
- BAMF Health — Grand Rapids, Michigan
- Profound Research LLC — Royal Oak, Michigan
- William Beaumont Hospital — Royal Oak, Michigan
- Mayo Clinic Rochester — Rochester, Minnesota
- St Louis University — St Louis, Missouri
- VA St Louis Health Care System — St Louis, Missouri
📞 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.
Explore by condition: All Oligometastatic Prostate Cancer (OMPC) 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.