Radioligand + Radiation Therapy for Prostate Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Radioligand + Radiation Therapy for Prostate Cancer?
Research shows that Lutetium-177 (Lu-177) radioligand therapy, which targets prostate-specific membrane antigen (PSMA), is promising for treating metastatic castration-resistant prostate cancer. Studies indicate it can reduce prostate-specific antigen (PSA) levels and metastasis, suggesting it may be effective in managing advanced prostate cancer.12345
Is the combination of radioligand and radiation therapy generally safe for humans?
Studies on Lutetium-177 PSMA radioligand therapy, used for prostate cancer, suggest it is generally safe, with some potential kidney-related concerns due to how the body processes the treatment. However, it has been used safely in patients with normal kidney function and even in those with a single functioning kidney.12678
How is the drug Lutetium Lu 177 PSMA-10.1 different from other treatments for prostate cancer?
Lutetium Lu 177 PSMA-10.1 is a new type of radioligand therapy that targets a specific protein on prostate cancer cells, potentially offering better treatment outcomes for patients with advanced prostate cancer that has not responded to other therapies. It is designed to improve upon existing treatments by optimizing how the drug behaves in the body, which may lead to more effective tumor responses.123910
What is the purpose of this trial?
This phase I trial tests the safety, side effects and best dose of radioligand therapy (lutetium Lu 177 PSMA-10.1 \[177Lu-rhPSMA-10.1\]) after prostate specific membrane antigen (PSMA) positron emission tomography (PET)-guided external beam radiotherapy in treating post-prostatectomy patients with prostate cancer that has come back after a period of improvement (recurrent). In this study, radioligand therapy is a radioactive drug called 177Lu-rhPSMA-10.1. It works by binding to PSMA-expressing prostate tumor cells and delivering the radioactive portion of the drug directly to the tumor cells while not harming normal cells. Radiation therapy such as external beam radiotherapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radioligand therapy with PSMA PET-guided external beam radiotherapy may kill more tumor cells in post-prostatectomy patients with biochemically recurrent prostate cancer.
Research Team
David M. Schuster, MD
Principal Investigator
Emory University Hospital/Winship Cancer Institute
Eligibility Criteria
Men over 18 with prostate cancer that has returned after surgery, who have detectable PSA levels and only show signs of cancer in the pelvic area on PSMA PET/CT scans. They should be relatively fit (ECOG status 0-2) and not have had prior radiotherapy or conditions like inflammatory bowel disease, severe kidney issues, high-risk urinary retention, significant liver damage, low blood counts, or serious acute illnesses.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants undergo external beam radiation therapy (EBRT) guided by PSMA PET
Radioligand Therapy
Participants receive 177Lu-rhPSMA-10.1 intravenously
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- External Beam Radiation Therapy
- Lutetium Lu 177 PSMA-10.1
Lutetium Lu 177 PSMA-10.1 is already approved in United States, European Union for the following indications:
- PSMA-positive metastatic castration-resistant prostate cancer
- PSMA-positive metastatic castration-resistant prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator