“Proper patient selection for any therapy is critical,” said Bela Denes, MD, Vice President of Medical Affairs at Lantheus. “This analysis of the OSPREY data further supports the utility of piflufolastat F 18 in men with suspected metastasis prior to definitive therapy and its potential impact on treatment recommendations.”
OSPREY Phase 2/3 Trial
The OSPREY trial was designed to assess the diagnostic performance of piflufolastat F 18 to detect prostate cancer in pelvic lymph nodes in subjects with high-risk, locally advanced prostate cancer (Cohort A). The primary endpoints for the trial were sensitivity and specificity of piflufolastat F 18 PET/CT imaging to detect metastatic prostate cancer within the pelvic lymph nodes relative to histopathology in Cohort A.
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OSPREY enrolled a cohort of 268 men with biopsy-proven prostate cancer who were considered candidates for radical prostatectomy and pelvic lymph node dissection. These patients were all considered to have high risk disease based on criteria such as Gleason score, PSA level, and tumor stage. Each patient received a single piflufolastat F 18 PET/CT scan from mid-thigh to skull vertex.
Three central readers independently interpreted each PET scan for the presence of abnormal piflufolastat F 18 uptake in pelvic lymph nodes in multiple sub-regions, including the common iliac lymph nodes. The readers were blinded to all clinical information. While readers also recorded the presence of piflufolastat F 18 PET-positive lesions in the prostate gland and outside the pelvis, those results were not included in the primary efficacy analysis.
A total of 252 patients (94%) underwent standard-of-care prostatectomy and template pelvic lymph node dissection and had sufficient histopathology data for evaluation of the pelvic lymph nodes. Surgical specimens were separated into three regions: left hemipelvis, right hemipelvis, and other. For each patient, piflufolastat F 18 PET results and histopathology results obtained from dissected pelvic lymph nodes were compared by surgical region. PET results in locations that were not dissected were excluded from analysis.
For the 252 evaluable patients, the mean age was 64 years (range 46 to 84 years), and 87% were white. The median serum PSA was 9.3 ng/mL. The total Gleason score was 7 for 19%, 8 for 46%, and 9 for 34% of the patients, with the remainder of the patients having Gleason scores of 6 or 10.
In the trial, the diagnostic performance of piflufolastat F 18 in detecting disease in pelvic lymph nodes (Cohort A) was compared with histopathology. When matched by lymph node location, piflufolastat F 18 showed specificity of 95-98%, sensitivity of 28-39%, and positive predictive value (PPV) of 72-81% meeting the specificity but not the pre-established sensitivity co-primary endpoint.
