Full Title
An International, Prospective, Open-Label, Multicenter, Randomized Phase III Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) Versus Observation to Delay Castration or Disease Recurrence in Adult Male Patients with Prostate Specific Membrane Antigen (PSMA) Positive Oligometastatic Prostate Cancer (OMPC) (WCG IRB)Purpose
Researchers want to see if AAA617 can slow the growth of advanced prostate cancer. They also want to learn if this treatment can delay the need to start hormonal therapy. Treatment with AAA617 will be compared to observation (no treatment other than standard targeted radiation therapy).
The people in this group have oligometastatic prostate cancer, which means the cancer has only spread to a few places. Their cancer cells also have a protein on their surfaces called prostate-specific membrane antigen (PSMA).
AAA617 is a radioligand therapy. This treatment delivers lutetium 177 (a radioactive substance) directly to prostate cancer cells with PSMA proteins on their surfaces.
If you join this study, you will be randomly assigned to get AAA617 or observation plus standard radiation therapy. Everyone in this study will first get stereotactic body radiotherapy, a highly targeted form of radiation therapy. Two-thirds of the participants will then get AAA617 and one-third will be observed.
Who Can Join
To join this study, there are a few conditions. You must:
- Have rising PSA after surgery or prostate radiation therapy.
- Have PSMA-positive oligometastatic prostate cancer with 5 or fewer cancer metastases.
- Not have not received hormonal therapy, chemotherapy, immunotherapy, or radiopharmaceutical therapy for oligometastatic prostate cancer. Any prior radiation therapy must have finished at least 4 weeks before starting the study treatment.
- Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
- Be age 18 or older.
Contact
For more information or to see if you can join this study, please call Dr. Daniel Gorovets’ office at 212-639-3983.