Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer (NCT03511664) | Clinical Trial Compass
CompletedPhase 3
Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer
United States861 participantsStarted 2018-05-29
Plain-language summary
The primary objective of this study was to compare the two alternate primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) in patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who received 177Lu-PSMA-617 in addition to best supportive/best standard of care (BSC/BSoC) versus patients treated with best supportive/best standard of care alone.
Who can participate
Age range18 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients must have the ability to understand and sign an approved informed consent form (ICF).
✓. Patients must have the ability to understand and comply with all protocol requirements.
✓. Patients must be \>= 18 years of age.
✓. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
✓. Patients must have a life expectancy \>6 months.
✓. Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
✓. Patients must be 68Ga-PSMA-11 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive, and eligible as determined by the sponsor's central reader.
✓. Patients must have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L).
Exclusion criteria
✕. Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.
✕. Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \[including monoclonal antibodies\]) within 28 days prior to day of randomization.
✕. Any investigational agents within 28 days prior to day of randomization.
What they're measuring
1
Radiographic Progression-free Survival (rPFS)
Timeframe: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
2
Overall Survival (OS)
Timeframe: From date of randomization until date of death from any cause, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) and up to 66 months (Final Analysis cut-off date = 14-Dec-2023)
✕. Known hypersensitivity to the components of the study therapy or its analogs.
✕. Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
✕. Transfusion for the sole purpose of making a subject eligible for study inclusion.
✕. Patients with a history of Central Nervous System (CNS) metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast).
✕. A superscan as seen in the baseline bone scan.