A Study to evaluate the radioligand 177Lu-PSMA-617 (Pluvicto^TM) in patients with naïve or minimally treated PSMA-positive metastatic hormone sensitive prostate cancer (mHSPC) (PSMAddition)

Patient Summary

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 (Pluvicto^TM) versus patients receiving Standard of Care without Pluvicto^TM. 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 Pluvicto^TM. 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 Pluvicto^TM slows or inhibits the progression of prostate cancer in patients with mHSPC receiving SoC and Pluvicto^TM versus patients receiving SoC without Pluvicto^TM. The information obtained from study will assist in the design of future Pluvicto^TM 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 Pluvicto^TM 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, Pluvicto^TM 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?

• Some key inclusion criteria include

1. Adults ≥ 18 years of age
2. Patient must be 68Ga-PSMA-11 PET/CT scan positive, and eligible as determined by sponsor central reader.
3. Patient must be treatment naive OR minimally treated based on other criteria. Please speak to the study doctor for more detail.
4. Patient must have metastatic disease to bone and/or soft tissue/visceral sites documented in one of 3 manners within 28 days of randomization. Please ask the study doctor for more detail.

• Some key exclusion criteria include

1. Patients with rapidly progressing tumor that requires urgent exposure to taxane-based chemotherapy
2. History of somatic or psychiatric disease that would interfere with study objectives and assessments
3. Symptomatic cord compression or clinical/radiological findings indicative of cord compression

What’s involved?

• Participants will receive
  • Pluvicto^TM by infusion and best Standard of Care including Androgen Receptor Directed Therapy (ARDT) + Androgen Deprivation Therapy (ADT) and the best supportive care.

Possible patient benefits

• This could slow and stop the progression of PSMA expressing prostate cancer and potentially prolong life as determined by radiographic progression analysis
• Patients will be under close medical supervision for safety during the study period

Possible Patient risks

• The use of Pluvicto^TM will provide no benefit for preventing disease progression in these patients.
• The use of Pluvicto^TM may also cause side effects

Clinical Trial Site

Trial site can be found here

Organization: Novartis

If you are interested in this trial, review the following:

• Clinicaltrials.gov Identifier: NCT04720157
• Use the “clinical trials glossary” and “dictionary” for words, phrases and treatments that you may not understand.

• Register your interest or comments about this trial with PHEN

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. Pluvicto^TM (prescribing information). Millburn, NJ:  Advanced Accelerator Applications USA, Inc. 2022.

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