Escalating Cycle 1 Dose of Lu-177-PSMA-617 for the Treatment of Metastatic Castration Resistant Prostate Cancer (NCT07682649)
A Phase 1 Study to Investigate Safety of Escalating Cycle 1 Dose of Lu-177-PSMA-617 Radioligand Therapy (RLT) in Metastatic Castration Resistant Prostate Cancer (mCRPC): The ESCENDO Trial
🩺 Plain-English Summary (8th-Grade Level)
This phase I trial studies the safety, side effects, and treatment cycle 1 best dose of Lu-177-PSMA-617 in patients with prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castration-resistant) and has spread from where it first started (primary site) to other places in the body (metastatic). Lu-177-PSMA-617 is a radioactive drug. It binds to a protein called prostate-specific membrane antigen (PSMA), which is found on prostate cancer tumor cells. Lu-177-PSMA-617 gives off radiation that may kill these tumor cells. It is a type of radioconjugate. Lu-177-PSMA-617 is currently used in a series of 6 intravenous infusions of the standard dosage, each separated by 6 weeks from the previous infusion. Investigators have observed that the first therapy administration (cycle 1) delivers better radiation treatment to the cancer than each of the following 5 infusions. Giving an increased dosage of Lu-177-PSMA-617 in treatment cycle 1 may have a better effect on metastatic castration-resistant prostate cancer than the standard dosage. The study does not change the total cumulative activity from what is used in the standard dosage treatment but gives an increased dosage in cycle 1 and reduces the total number of cycles.
Who can join: Review the eligibility criteria below.
Location: University of Michigan Rogel Cancer Center — Ann Arbor, Michigan
Age range: 18 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 (1 Sites)
- University of Michigan Rogel Cancer Center — Ann Arbor, Michigan
📞 Contact the Study Coordinator
Phone: (800) 865-1125
Email: CancerAnswerLine@med.umich.edu
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 Carcinoma
- Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study — Seattle, Washington
- Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease — San Francisco, California
- Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer — Seattle, Washington
- SPECT/CT Imaging for Dosimetry in 177Lu-PSMA-617 (Pluvicto) Therapy — Ann Arbor, Michigan
- Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial — Anchorage, Alaska
Explore by condition: All Metastatic Castration-Resistant Prostate Carcinoma 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.