Lutetium-177 (Lu177) Prostate-Specific Antigen (PSMA)-Directed EndoRadiotherapy — RESIST-PC  

Metastatic Castration Resistant Prostate Cancer Clinical Trial

Official title: PSMA-directed endoRadiothErapy of Castration-reSISTant Prostate Cancer (RESIST-PC). A Phase II Clinical Trial

Status Terminated

Clinical Trial Summary

This was an open-label, multicenter, prospective trial to assess safety and efficacy of 177Lu-PSMA-617 in patients with metastatic castration resistant prostate cancer.

Clinical Trial Description

Upon inclusion patients were randomized in a 1:1 ratio into two treatment doses. Radioligand therapy (RLT) were performed by repeated intravenous (i.v.) injection of 6.0 gigabecquerel (GBq) (+/- 10%) or 7.4 GBq (+/- 10%) 177Lu-PSMA-617 every 8+/- 1 weeks until reaching four cycles or threshold maximum dose to the kidneys of 23 Gray (Gy). All doses after labeling were presented in buffered solution for i.v. injection.

In the initial plan for the study design a total of 200 patients with histologically proven prostate cancer and metastatic castration-resistant prostate cancer (mCRPC) were to be enrolled, however due to early stopping of enrollment only 71 patients were enrolled at time of data base lock. Each patient underwent a screening visit within 14 days prior to receiving study drug. Treatment was continued until either of the following conditions applied:

• Prostate-specific antigen (PSA)/radiographic progression at >= 12 weeks

• Completion of four RLT cycles

• 23 Gy kidney dose would be exceeded by the next cycle as estimated by dosimetry

• Patient withdrawal (e.g. appearance of intolerable adverse events). ;

Related Conditions & MeSH terms

• Metastatic Castration Resistant Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT03042312
• Study type: Interventional
• Source: Endocyte
• Status: Terminated
• Phase: Phase 2
• Start date: July 12, 2017
• Completion date: January 15, 2020