EUSA announces publication of PROSTASCINT imaging for prostate cancer in official journal of American Society

Nov 3 2010

EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, announced today the publication of 10-year outcome data showing that PROSTASCINT® (capromab pendetide) fusion imaging is an effective tool for targeting and guiding the dosing of prostate cancer radiotherapy. The data also show that PROSTASCINT images can be a significant predictor of disease-free survival. The data are available online in the International Journal of Radiation Oncology Biology Physics, the official journal of the American Society for Radiology and Oncology, prior to publication in the December 2010 issue.

PROSTASCINT is a US FDA approved monoclonal antibody-based radiopharmaceutical imaging agent for use in newly-diagnosed patients with biopsy-proven prostate cancer. It is also used in post-prostatectomy patients where there is a high clinical suspicion of hidden metastatic disease.

"These long-term outcomes data demonstrate the significant benefits PROSTASCINT imaging offers as a tool for defining tumor stage prior to treatment and for enabling image-guided radiotherapy in clinically localized prostate cancer," stated the study's Principal Investigator, Rodney J. Ellis, M.D., Vice-Chairman for Clinical Research and Director of Genito-Urinary Oncology, Brachytherapy, and Advanced Image Guided Radiotherapy at Case Western Reserve University and University Hospitals of Cleveland. "This study reports excellent outcomes when PROSTASCINT is utilized to direct increased radiation doses to regions of the prostate with higher tumor burden, and shows its utility as a predictive tool, identifying patients who may require increased vigilance in post-therapy follow-up, and/or those patients who might benefit from more aggressive treatment, such as adjuvant chemotherapy."

Study Details

The study involved 239 patients presenting for primary radiotherapy with a clinical diagnosis of prostate cancer thought to be confined to the prostate gland. All patients underwent PROSTASCINT SPECT/CT (fusion) imaging prior to radiotherapy. The PROSTASCINT imaging identified 22 patients (9.2%) as suspicious for metastatic disease in the lymph nodes. However, conventional imaging using CT or MRI alone or other staging tools could not confirm these findings.

All patients were treated by low dose brachytherapy using radioactive seeds, and PROSTASCINT fusion images guided dose escalation to regions of higher tumor burden. At 10-year follow up, disease specific survival was 99% when PROSTASCINT fusion imaging defined the tumor as localized, versus 86.4% in patients reported as having metastatic disease in the lymph nodes (p =0.0001) by PROSTASCINT fusion imaging. Despite the significantly different outcome between these two groups, conventional imaging with CT or MRI alone did not identify nodal metastases in any patients prior to treatment. "These highly significant 10-year outcomes data demonstrate that PROSTASCINT fusion imaging can accurately identify otherwise hidden nodal metastases leading to better treatment decisions and therefore better outcomes for patients," said Jim Mitchum, US President of EUSA Pharma Inc.