At a glance
ClinicalIndex Comparison RecordPhase 2Active· 50 enrolled
Drug / intervention
177Lu-PSMA-617 +1 moredrug
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.
Phase I/ll Dose-escalation Study of Fractionated Dose 177Lu-PSMA-617 for Progressive Metastatic Castration Resistant Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating 177Lu-PSMA-617 and 68Ga-PSMA-HBED-CC for Prostate Cancer. Active but no longer recruiting, targeting 50 participants across 2 sites.
Detailed Summary
The purpose of this study is to find the highest dose level of the study drug, 177Lu-PSMA-617 that can be given without severe side effects for advanced prostate cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 2Active
2017201820192020202120222023202420252026
Enrollment StartDec 2016
First PostedFeb 2017
Primary CompletionSep 2021
TodayJul 2026
Study CompletionAug 2026
First PostedFeb 3, 2017
Enrollment StartDec 1, 2016
Primary CompletionSep 30, 2021
Study CompletionAug 1, 2026
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 9.4 years ago
Interventions
177Lu-PSMA-617drug
177Lu-PSMA-617 \[50mCi (1.85GBq) - 300mCi (11.1GBq)\] intravenous X2 doses, 2 weeks apart (Visit 1 and 2)
68Ga-PSMA-HBED-CCdrug
68Ga-PSMA-HBED-CC \[5 ±2mCi or 185 ±74MBq\] intravenous during screening and at 12 weeks with standard imaging