Radioligand Efficacy Comparison by Initial PSA-Response Outcome in Metastatic CRPC With Lutetium 177Lu PSMA RLT (RECIPROCAL)
Alliance for Clinical Trials in Oncology
Summary
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.
Description
The primary and secondary objectives of the study: PRIMARY OBJECTIVES: I. To compare the overall survival (OS) of patients with metastatic castration-resistant prostate carcinoma (mCRPC) receiving prostate-specific antigen (PSA) adaptive dosing of lutetium 177 Lu prostate specific membrane antigen radioligand therapy (177Lu PSMA RLT) to that of patients receiving standard dose 177Lu PSMA RLT every 6 weeks. II. To compare quality of life, as measured by Functional Assessment of Cancer Therapy- Prostate (FACT-P) total scores averaged across the first 30 months, in patients with mCRPC who rece…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * 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 * PRE-REGISTRATION (STEP 0): Patients must have progressive mCR…
Interventions
- DrugLutetium Lu 177 Vipivotide Tetraxetan
Given IV
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedurePatient Monitoring
Undergo PSA monitoring
- ProcedureComputed Tomography
Undergo CT
- ProcedureBone Scan
Undergo Bone Scan
- ProcedurePSMA PET Scan
Undergo PSMA PET Scan
- ProcedureMRI
Undergo MRI
- OtherQuestionnaire Administration
Ancillary studies
Locations (129)
- Providence Alaska Medical CenterAnchorage, Alaska
- AIS Cancer Center at San Joaquin Community HospitalBakersfield, California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, California
- City of Hope at Irvine LennarIrvine, California
- Cedars-Sinai Medical CenterLos Angeles, California
- UC Irvine Health/Chao Family Comprehensive Cancer CenterOrange, California