CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
[68Ga]-PSMA-R2drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03490032
NCT03490032Phase 2Completed
CompareCT.gov

A Phase 1/2 Open-label, Multi-center, Safety and Tolerability Study of a Single Dose of 68Ga-PSMA-R2 in Patients With Biochemical Relapse (BR) and Metastatic Prostate Cancer (mPCa)

Advanced Accelerator Applications·interventional·Posted Apr 6, 2018·Updated Nov 17, 2020

In Brief

A Phase 2 clinical trial evaluating [68Ga]-PSMA-R2 for Prostate Cancer Metastatic. Completed, enrolled 30 participants across 5 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer Metastatic
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 6, 2018
Enrollment StartMay 23, 2018
Primary CompletionAug 20, 2019
Study CompletionSep 13, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.2 years ago

Interventions

[68Ga]-PSMA-R2drug

radio-labelled PSMA ligand