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NCT03490032 · ClinicalTrials.gov registry record · Phase 1
68Ga-PSMA-R2 in Patients With Biochemical Relapse (BR) and Metastatic Prostate Cancer (mPCa)
A Phase 1 study, sponsored by Advanced Accelerator Applications.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT03490032: Completed Phase 1 study, sponsored by Advanced Accelerator Applications.
NCT03490032 is a Phase 1 study that has completed, run by Advanced Accelerator Applications. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03490032, a Phase 1 study, has completed, sponsored by Advanced Accelerator Applications.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This was an open-label, multicenter, single dose, Phase I/II study to evaluate the safety and tolerability of a single administration of 3 mega Becquerel (MBq)/kg, but not less than 150 MBq and not more than 250 MBq, of 68\^Ga-PSMA-R2 in adult male patients with biochemical relapse (BR) and metastatic prostate cancer (mPCa).
Primary Outcome
Treatment-emergent adverse events (TEAEs) were collected from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitori
Interventions
- DRUG [68Ga]-PSMA-R2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-05-23 |
| Est. Completion | 2019-09-13 |
| Phase | Phase 1 |
What the finished NCT03490032 record still lists
NCT03490032 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which [68Ga]-PSMA-R2 is the first listed.
NCT03490032 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03490032 about?
NCT03490032 is a clinical study titled "68Ga-PSMA-R2 in Patients With Biochemical Relapse (BR) and Metastatic Prostate Cancer (mPCa)". This was an open-label, multicenter, single dose, Phase I/II study to evaluate the safety and tolerability of a single administration of 3 mega Becquerel (MBq)/kg, but not less than 150 MBq and not more than 250 MBq, of 68\^Ga-PSMA-R2 in adult male patients with biochemical relapse (BR) and metastat...
What is the current status of trial NCT03490032?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2018-05-23. Estimated completion is 2019-09-13.
What interventions are being tested in trial NCT03490032?
The interventions under investigation include: [68Ga]-PSMA-R2 (DRUG).
Who is sponsoring clinical trial NCT03490032?
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 NCT03490032's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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