NCT04663997

177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer

A Randomized Phase II Study of 177 LuPSMA-617 vs Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer and PSMA-Positive Disease

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

177Lu PSMA 617 is a new type of therapy which is designed to deliver high doses of radiation directly to prostate cancer sites in the body. The purpose of this study is to find out whether 177Lu PSMA 617can slow the growth of prostate cancer compared to standard chemotherapy treatment

Detailed description

The standard or usual treatment for this disease is a chemotherapy drug called docetaxel, given by intravenous every 3 weeks, for up to 12 treatments. 177Lu-PSMA-617 is a new type of therapy for prostate cancer. Laboratory tests show that it may help slow the growth of prostate cancer. 177Lu-PSMA-617 has been shown to shrink tumours in animals and has been studied in limited numbers of men with prostate cancer and seems promising but it is not clear if it can offer better control of prostate cancer compared to docetaxel chemotherapy .

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	177Lu-PSMA-617	IA of 7.4GBq (± 10%) IV every 6 weeks; maximum 6 cycles
DRUG	Docetaxel	75mg/m2 IV every 3 weeks maximum 12 cycles

Timeline

• Start date: 2021-08-11
• Primary completion: 2025-08-25
• Completion: 2026-12-31
• First posted: 2020-12-11
• Last updated: 2026-03-27

Locations

10 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study