Lutetium-PSMA (Lu-PSMA) Prostate Disease Trial
The intention of this study would be to investigate the security, tolerability, and radiation dosimetry of 177Lu-PSMA-R2 and further determine initial efficacy information in patients with metastatic castration-resistant prostate disease (mCRPC). a stage 1 portion of the study will determine the recommended dose of 177Lu-PSMA-R2 for radio-ligand therapy (RLT) of mCRPC, as well as the Phase 2 portion will expand into about 60 patients documenting the activity that is preliminaryanti-tumor feedback) of continued treatments applied, continuing security tests and obtaining well being information.
WHEN WILL MOST LIKELY THE TEST BE OPENED?
The trial has unwrapped at the facility in Phoenix Arizona.
WHAT IS THE EXPECTED DURATION OF THE DEMO?
We expect the test to approximately enroll participants for 12 – eighteen months. You’ll find three series of therapy then we continue steadily to follow-up by using these men to assess how they are performing every 3 months. Imaging assessments with Gallium-68 PSMA PET/CT checking is performed before the earliest cures and next at each and every follow up explore. I’VE HAD PAST DOCETAXEL (ALSO REFERRED TO AS TAXOTERE) CHEMOTHERAPY, AM We STILL ELIGIBLE FOR THIS RESEARCH?
Yes, you must have already obtained treatment with docetaxel chemotherapy or have now been provided chemotherapy and didn’t continue along with it. Moreover only one round that is previous of (typically 6 series) are authorized.
WILL EVERYONE INSIDE RESEARCH RECEIVE LUTETIUM?
Yes. Unlike different research where there is randomization to the medication or no investigational therapy, in this test all clients will get the Lu-PSMA treatments. There is no “placebo” or treatment that is inactive this test: everybody else mixed up in trial will get remedy that people discover features a potential for assisting them.
WILL LU-PSMA BE AVAILABLE OUTSIDE OF THE CLINICAL TEST?
No. We’re not in a position to provide Lu-PSMA beyond your trial that is clinical. It is possible it may possibly be available somewhere else but at present it’s still an investigational medication.