About this trial

This randomized phase III trial examines whether lengthening the dosage interval in an adaptive manner for the prostate cancer drug lutetium 177 Lu PSMA RLT improves quality of life without decreasing lifespan when compared to the standard way this medication is given. This study is for patients with hormone resistant prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body. Hormone resistant prostate cancer often has many cells containing a protein called prostate-specific membrane antigen (PSMA) on their surface. The normal cells in the prostate do not normally express as much PSMA protein on their surface as cancer cells. Lutetium 177 Lu PSMA RLT binds to the PSMA protein on the tumor cells. It builds up in these cells and gives off radiation that may kill them. Typically, this medication is given at the same dose every 6 weeks for up to 6 doses. In this trial, researchers want to see if treatment following the first two doses of lutetium 177 Lu PSMA RLT can be delayed until there is evidence of disease activity. This may be an effective way to improve quality of life without decreasing lifespan in patients with advanced prostate cancer.

Eligibility criteria

Qualifiers

PRE-REGISTRATION (STEP 0): Patients must have histological, pathological, and/or cytological confirmation of prostate adenocarcinoma

PRE-REGISTRATION (STEP 0): Patients must have a positive PSMA PET/CT scan (either gallium Ga 68 gozetotide [68Ga-PSMA-11], fluorine F 18 piflufolastat [18F- DCFPyl], or fluorine F 18 flotufolastat gallium [18F-rhPSMA-7.3]), as defined as uptake greater than liver with no PSMA negative measurable soft tissue disease

PRE-REGISTRATION (STEP 0): PSA greater than 2.0 ng/mL

Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Lutetium Lu 177 Vipivotide Tetraxetan
  • Biospecimen Collection
  • Patient Monitoring
  • Computed Tomography
  • Bone Scan
  • PSMA PET Scan
  • MRI
  • Questionnaire Administration

Treatment groups

1,524 Participants
are divided into 3 treatment groups

Locations

102
Alaska
Providence Alaska Medical Center99508, Anchorage United States
California
AIS Cancer Center at San Joaquin Community Hospital93301, Bakersfield United States
City of Hope at Irvine Lennar92618, Irvine United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care92612, Irvine United States

Sponsors and collaborators

Alliance for Clinical Trials in Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator