PSMAddition Patient Summary
A Study to evaluate the radioligand 177Lu-PSMA-617 (PluvictoTM) in patients with naïve or minimally treated PSMA-positive metastatic hormone sensitive prostate cancer (mHSPC) (PSMAddition)
The primary objective of this study is to evaluate radiographic progression free survival (rPFS) in patients with mHSPC receiving Standard of Care and 177Lu-PSMA-617 (PluvictoTM) versus patients receiving Standard of Care without PluvictoTM. In this international, open-label, prospective, phase III study, with naïve or minimally treated mHSPC will be randomized in a 1:1 ratio to receive Standard of Care (SoC) with or without the radioligand PluvictoTM. In this study, the combination for Androgen Receptor Directed Therapy (ARDT) + Androgen Deprivation Therapy (ADT) are allowed as SoC.
What is the purpose?
The major purpose of the study is to determine whether treatment with PluvictoTM slows or inhibits the progression of prostate cancer in patients with mHSPC receiving SoC and PluvictoTM versus patients receiving SoC without PluvictoTM. The information obtained from study will assist in the design of future PluvictoTM based clinical trials in patients with advanced prostate cancer.
What type of therapy is used?
This is the first radioligand therapy approved by the FDA PluvictoTM for prostate cancer patients with prostate-specific membrane antigen (PSMA) positive mCRPC who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. It is a type of precision cancer treatment combining a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle). After administration into the bloodstream, PluvictoTM binds to target cells, including prostate cancer cells that express PSMA, a transmembrane protein1. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells disrupting their ability to replicate and/or triggering cell death1.
Who can participate?
Possible patient benefits
Possible Patient risks
Clinical Trial Site
Trial site can be found here
If you are interested in this trial, review the following:
PHEN Contact: 617-481-4020
Please Note: This information is provided for educational and awareness purposes. A decision on clinical trials participation is to be made between the patient and his doctor.
1. PluvictoTM (prescribing information). Millburn, NJ: Advanced Accelerator Applications USA, Inc. 2022.