NCT04825652

177Lu-PSMA-617 Managed Access Program for mCRPC Patients

Managed Access Program (MAP) Cohort Treatment Plan [CAAA617A12001M] to Provide Access to 177Lu-PSMA-617 for Patients With Metastatic Castration-resistant Prostate Cancer.

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Advanced Accelerator Applications · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: —

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.

Detailed description

PSMA-11 will be provided in certain cases where it may be required as a diagnostic imaging agent. PSMA-11 is used to confirm the presence of PSMA positive lesions in patients, which then makes them eligible for treatment with 177Lu-PSMA-617.

Conditions

• Metastatic Castration-resistant Prostate Cancer (mCRPC)

Interventions

Type	Name	Description
DRUG	177Lu-PSMA-617	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).

Timeline

• First posted: 2021-04-01
• Last updated: 2023-01-13