A Phase 2 Trial of Combined Lutetium-PSMA Theranostics and Docetaxel in Newly Diagnosed Metastatic Hormone-Naive Prostate Cancer
Abstract
Radiotherapy is a highly effective treatment for prostate cancer and cures many men who have cancers that are confined to the prostate gland. This research will use new technology to treat patients with prostate cancers that have spread by using a radioactive substance that can be smartly targeted to tumors. Most prostate cancer cells have a molecule called prostate-specific membrane antigen (PSMA) on their surface that can now be targeted with drugs. By attaching radioactive substances to these drugs, it is possible to deliver high doses of radiation to prostate cancer cells and kill them. Lutetium-177 PSMA is a highly radioactive drug that is injected into a vein and is then taken up into prostate cancer anywhere in the body. The radiation it emits travels only 1 mm through body tissue, enabling targeted killing of cancer cells without damaging normal tissues. We recently published data showing striking responses with Lutetium-177 PSMA in patients with advanced prostate cancers that had spread and who had failed all available treatment options. Treatment was well tolerated with few side effects, and in addition, men felt a lot better with reduced pain and improvements in their general wellbeing. We think this treatment may be more effective if used earlier in the course of the disease rather than as a last-line of treatment. In this clinical trial, we will use Lutetium-177 PSMA in patients with newly diagnosed prostate cancer that has spread. The current standard of care in these patients is drugs that lower the male hormone testosterone (hormone therapy) and chemotherapy (docetaxel), given together. In this trial, we will add Lutetium-177 PSMA to these existing treatments. While all three treatments work independently to kill prostate cancer, the effectiveness of Lutetium-177 may well be increased if given at the same time as hormone therapy and chemotherapy, and we believe combining them will further improve outcomes, including the potential for a cure. This clinical trial will evaluate patients with newly diagnosed prostate cancers that have already spread beyond the prostate. These patients have a poor outlook and are currently incurable. We hypothesize that treatment intensification by the addition of Lutetium-177 PSMA will improve their outcomes. Thirty-five patients will receive multiple cycles of Lutetium-177 PSMA combined with docetaxel chemotherapy and hormone therapy. We aim to determine the effectiveness and safety of this triple combination. This trial will be completed within 3 years and, if successful, will lead to a larger study that could change global practice within 5 years. In doing so, our research aims to improve outcomes for men with lethal prostate cancer, with the major anticipated benefit of this treatment being improved survival without additional significant side effects.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Nov 19, 2019
- Source ID
- W81XWH1910651
Entities
People
- Michael S Hofman
Organizations
- United States Army
- University of Melbourne