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NCT03490838 · ClinicalTrials.gov registry record · Phase 1
177Lu-PSMA-R2 in Patients With PSMA Positive Progressive, Metastatic, Castration Resistant Prostate Cancer
A Phase 1 study, sponsored by Advanced Accelerator Applications.
- Terminated
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT03490838: Clinical Trial Phase 1 study, sponsored by Advanced Accelerator Applications.
NCT03490838 is a Phase 1 study that was terminated before completion, run by Advanced Accelerator Applications. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03490838, a Phase 1 study, was terminated before completion, sponsored by Advanced Accelerator Applications.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This Phase 1/2 study is intended to investigate the safety, tolerability, and radiation dosimetry of 177Lu-PSMA-R2 and further assess preliminary efficacy data in patients with metastatic castration-resistant prostate cancer (mCRPC). The Phase 1 portion of the study will determine the recommended dose of 177Lu-PSMA-R2 for radio-ligand therapy (RLT) of mCRPC, and the Phase 2 portion will expand into approximately 60 patients documenting the preliminary activity (anti-tumor response) of repeated treatments administered, continuing safety assessments and collecting QoL data.
Primary Outcome
A dose-limiting toxicity (DLT) is defined as any toxicity not attributable to the disease or disease-related processes under investigation, the time window for DLT assessment period is Cycle 1. To be considered a DLT, it must be related to the IP (attributions: possible, probable, and definite) while fulfilling one of the following criteria as per the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
Interventions
- DRUG 177Lu-PSMA-R2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2018-05-24 |
| Est. Completion | 2022-06-02 |
| Phase | Phase 1 |
Why NCT03490838 stopped before completion
NCT03490838 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which 177Lu-PSMA-R2 is the first listed.
NCT03490838 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03490838 about?
NCT03490838 is a clinical study titled "177Lu-PSMA-R2 in Patients With PSMA Positive Progressive, Metastatic, Castration Resistant Prostate Cancer". This Phase 1/2 study is intended to investigate the safety, tolerability, and radiation dosimetry of 177Lu-PSMA-R2 and further assess preliminary efficacy data in patients with metastatic castration-resistant prostate cancer (mCRPC). The Phase 1 portion of the study will determine the recommended do...
What is the current status of trial NCT03490838?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2018-05-24. Estimated completion is 2022-06-02.
What interventions are being tested in trial NCT03490838?
The interventions under investigation include: 177Lu-PSMA-R2 (DRUG).
Who is sponsoring clinical trial NCT03490838?
This trial is sponsored by Advanced Accelerator Applications, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03490838's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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