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

NCT04825652 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2023-01-13

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Advanced Accelerator Applications

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04825652 on ClinicalTrials.gov