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 | Phone | Principal Investigator | Recruitment Status | |
|---|---|---|---|---|---|
| Royal Adelaide Hospital | Anne Milton | anne.milton@sa.gov.au | 08 7074 2342 | Tan | Recruiting |