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  • TheraP

    Acronym: 

    ANZUP 1603

    ACTRN/NCT /ethics: 

    ACTRN12617001590358

    Scientific title: 

    TheraP: A randomised phase 2 trial of 177-Lutetium-Prostate Specific Membrane Antigen-617 (177Lu-PSMA617) theranostic versus cabazitaxel in progressive metastatic castration resistant prostate cancer (ANZUP1603)

    Summary of trial and patient characteristics

    Cancer Type Prostate
    Trial Type Treatment
    Phase Phase II Tumour Stream Prostate
    Age Range 18 years and older Cancer Stage Metastatic or Widespread
    Sex Male Anticipated Start Date 2018-01-31
    Molecular Target Anticipated End Date 2019-11-30
    Cancer Type Prostate
    Trial Type Treatment
    Phase Phase II
    Age Range 18 years and older
    Sex Male
    Molecular Target
    Tumour Stream Prostate
    Cancer Stage Metastatic or Widespread
    Anticipated Start Date 2018-01-31
    Anticipated End Date 2019-11-30

    Trial Summary

    The primary purpose of this trial is to evaluate the efficacy and safety of a new radionuclide therapy (177Lu-PSMA617) for advanced prostate cancer, in comparison to the standard care, cabazitaxel. 177Lu-PSMA617 is a radioactive molecule that specifically attaches to cells with high amounts of PSMA on the surface of the cells. This allows the radioactivity to be delivered mainly to the prostate cancer cells wherever they have spread, while sparing most normal tissues. Who is it for? You may be eligible to participate in this trial if you have been diagnosed with metastatic castration resistant prostate cancer for which you have previously received docetaxel. Study details All patients enrolled into this trial will be randomly allocated (by chance) to receive either 177Lu-PSMA617 or the standard care cabazitaxel chemotherapy. Patients in the 177Lu-PSMA617 arm will receive up to six six-weekly doses of 177Lu-PSMA617. Patients in the cabazitaxel arm will receive up to ten three-weekly doses of cabazitaxel. Treatment in both arms will continue until your cancer progresses, you have unmanageable side effects or until the maximum number of treatments has been reached. All patients will complete scans and questionnaires as part of this trial, up to every 3 weeks, to assess the impact of the treatment on your cancer, on your pain levels and your quality of life. It is hoped that this trial will provide further information on the risks and benefits of 177Lu-PSMA617 treatment compared with cabazitaxel in men with advanced prostate cancer.

    Lay Summary

    TheraP: A randomised phase 2 trial of 177-Lutetium-Prostate Specific Membrane Antigen-617 (177Lu-PSMA617) theranostic versus cabazitaxel in progressive metastatic castration resistant prostate cancer (ANZUP1603)

    Sponsor / Cooperative group

    ANZUP

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Royal Adelaide Hospital Anne Milton anne.milton@sa.gov.au 08 7074 2342 Dr Hsiang Tan Recruitment on Hold