177Lu-PSMA-617 Managed Access Program for mCRPC Patients
NCT04825652 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2023-01-13
Summary
The purpose of this Cohort Treatment Plan is to allow access to 177Lu-PSMA-617 for eligible patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC). The patient's treating physician should follow the suggested treatment guidelines and comply with all local health authority regulations.
Conditions
- Metastatic Castration-resistant Prostate Cancer (mCRPC)
Interventions
- DRUG
-
Participants will receive 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles.
- DRUG
-
PSMA-11
Patients will receive a dose of gallium (68Ga) gozetotide that is 1.8-2.2 MBq/kg of body weight (0.049-0.059 mCi/kg), with a minimum dose of 111 MBq (3mCi) up to a maximum dose of 259 MBq (7 mCi).
Sponsors & Collaborators
-
Advanced Accelerator Applications
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
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