PSMAfore Patient Summary

 

177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer (PSMAfore)

Patient Summary

The purpose of this study is to determine whether Lutetium Lu 177 vipivotide tetraxetan (PluvictoTM) improves the radiographic progression free survival (rPFS) or death compared to a change in androgen receptor-directed therapy (ARDT) in metastatic castration resistant prostate cancer (mCRPC) men that were previously treated with an alternate ARDT but did not receive a taxane-containing therapy for the treatment of CRPC or mHSPC.

What is the Purpose?

The clinical trial objective is to determine whether treatment with PluvictoTM will slow or stop the progression prostate cancer in men with progressive PSMA-positive mCRPC compared to participants treated with ARDT.

What type of therapy is used?

PluvictoTM is the first FDA approved radioligand therapy, which is indicated for the treatment of adult 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?

  • Some key inclusion criteria include (not an exhaustive list – for further details, please speak to the study doctor)
  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. Must have received one prior approved 2nd generation ARDT and have documented progression on that therapy
  4. Must have progressive mCRPC
  • Some key exclusion criteria include (not an exhaustive list – for further details, please speak to the study doctor)
  1. Previous PSMA-targeted radioligand therapy
  2. Prior treatment for metastatic prostate cancer with cytotoxic chemotherapy, immunotherapy or biological therapy
  3. Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy
The above is not an exhaustive list, for further information or please speak to the study doctor.

What’s involved?

  • Participants will receive:
    • PluvictoTM by IV infusion once every 6 weeks for 6 cycles. Best supportive care, including ADT may be used.
    • Best supportive care, including ADT may be used.

Possible patient benefits:

  • This therapy could slow and stop the progression of prostate cancer and potentially prolong life.
  • Patients will be under close medical supervision for safety during the study period.

Possible patient risks: 

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

Clinical Trial Site:

Trial sites can be found here

Organization: Novartis

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

Register your interest or comments about this trial with PHEN

PHEN Contact: 617-481-4020

1.PluvictoTM [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc.; 2022.

 

   Go Back

 













PHEN,Inc. © 2022 All rights reserved