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

Official Title

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

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

Trial Description

Primary Outcome:

  • Progression-free survival
Secondary Outcome:
  • Progression-free survival rate at 6 months defined by PSA
  • Progression-free survival rate at 6 months defined by PCWG 3
  • Progression-free survival rate at 6 months defined by RECIST 1.1
  • Second rPFS in patients who meet the criteria for rPFS and cross over to the alternate therapy
  • Time to commencement of third line therapy
  • Overall Survival
  • Proportions of patients with decreased PSA from baseline and the magnitude of change
  • Clinical benefit rate (CBR) > 24 weeks (RECIST v1.1).
  • Response duration including partial response, complete response or stable disease > 24 (RECIST v1.1)
  • Adverse event (AE) profile (CTCAE v5.0)
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 .

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society