Long-term Outcomes Data Validates the Utility of PROSTASCINT in Guiding Targeted Prostate Cancer Treatment and Predicting Disease Free Survival
LANGHORNE, Pa., Nov. 4 /PRNewswire/ -- EUSA Pharma announced
that PROSTASCINT® (capromab pendetide) fusion imaging was shown
to effectively guide prostate cancer therapy targeting and dosing
and is a significant predictor of disease free survival, according
to data presented on Tuesday, November 3, 2009 at the 51st American
Society for Therapeutic Radiology and Oncology (ASTRO) annual
meeting in Chicago, Illinois.
An abstract entitled "Long-term outcomes following IGRT for
localized prostate cancer: dose escalation to SPECT/CT determined
biologic target volumes and the bDFS predictive value of capromab
pendetide" was presented during podium session at ASTRO's annual
meeting. The abstract describes a 10-year patient outcomes research
project conducted by Dr. Rodney Ellis and colleagues (Case Western
Reserve University and Aultman Hospital ). This research focused on
the use of PROSTASCINT® (capromab pendetide), a monoclonal
antibody, linked to the radioisotope Indium-111 that specifically
targets prostate-specific membrane antigen (PSMA), and is used in
the evaluation of patients at risk for metastatic prostate cancer.
The PROSTASCINT images were co-registered or fused with CT image
sets (SPECT/CT). Areas demonstrating increased PROSTASCINT
concentration on these fused image sets defined biologic target
volumes which were used to guide dose escalation to 150% of the
prescribed prostate glandular dose. Patients received additional
permanent radioactive seeds in those areas. Biochemical disease
free survival (bDFS) was also evaluated based on risk group status
and on the presence or absence of lymph node metastases found on
the PROSTASCINT image sets at baseline.
Fusion imaging is an in vivo diagnostic technique that combines
anatomic and functional information to provide information that
cannot be obtained with separate imaging modalities alone. Image
fusion can combine computed tomography (CT) or magnetic resonance
(MR) with radionuclide imaging using single-photon emission
computed tomography (SPECT) to image an agent such as
PROSTASCINT.
When PROSTASCINT was first introduced to the market, image
fusion was not commonly used in aiding scan results. However, newer
fusion imaging techniques, combined with treatment planning, allow
the physician to target higher doses of radiation to specific areas
within the prostate containing prostate cancer cells -- while
keeping radiation levels to important structures such as the
urethra within acceptable limits.
Study Details
The study involved 239 consecutive patients who underwent
radio-immunoguided (PROSTASCINT SPECT/CT) permanent prostate
brachytherapy. One hundred and sixteen patients had low-risk
disease (no risk factors), 72 were intermediate risk (one risk
factor), and 51 were high risk (two risk factors). Risk factors
included PSA level equal to or greater than 10, stage equal or
greater than T2b, and Gleason grade equal or greater than 7.
Biochemical disease-free survival (bDFS) was calculated using both
the Phoenix and the American Society for Therapeutic Radiology and
Oncology (ASTRO) consensus criteria. The cohort included 22
patients, all of whom were thought to have a clinical diagnosis of
localized prostate cancer, however had evidence of lymph node
involvement on the SPECT/CT In-111 capromab pendetide images.
The 10 year actuarial analysis by risk groups (RG) showed bDFS
to be: 93.5% for low-risk patients; 86.9% for intermediate risk;
and 63.6% for high risk patients (p = 0.0002). The rate of bDFS for
patients having positive SPECT/CT image findings (indicating
metastases) was 65.5% vs. 86.6% for those with negative image
findings (p = 0.0014). Analysis of bDFS by RG subset and SPECT/CT
image findings showed the following using the Phoenix
criteria:
Image Positive (%) Image Negative (%) p-value
Low Risk 90.0 93.6 0.4540
Interm Risk 57.1 90.2 0.0055
High Risk 30.0 68.2 0.0520
A significant finding from this long-term follow-up study is
that the presence of metastatic disease in the lymph nodes based on
SPECT/CT imaging with PROSTASCINT In-111 capromab pendetide was
found to be an independent and significant predictor of biochemical
failure for the intermediate risk patients by both bDFS
criteria.
"From this long term follow-up study, PROSTASCINT SPECT/CT
fusion demonstrated significant benefit as a tool for pre-treatment
staging and image-guided treatment planning in clinically localized
prostate cancer patients," said principal investigator Rodney J.
Ellis, M.D., FACRO. Dr. Ellis is a Radiation Oncologist at Aultman
Hospital, Associate Professor Radiology N.E.O.U.C.O.M., and
Assistant Professor Urology at CASE School of Medicine.
"PROSTASCINT identified true-localized disease versus previously
undetected metastatic disease, significantly predicting for disease
specific survival and freedom from biochemical failure. We found
PROSTASCINT SPECT/CT findings to be significant for the prediction
of biochemical disease free survival in intermediate-risk patients
and high-risk patients. The presence of occult or previously
undetected metastatic disease on SPECT/CT imaging may potentially
benefit patient selection for early and more aggressive therapies
or even help select patients for clinical trials of adjuvant
chemotherapy."
About Prostate Cancer
Approximately one in every six men will develop prostate cancer.
It is the most common non-skin cancer among men in America.
According to the Prostate Cancer Foundation, more than 192,000 new
cases of prostate cancer will be diagnosed this year in the United
States, and approximately 27,000 men will die of the disease. It is
estimated that there are more than 2 million men living with
prostate cancer in the US.
PROSTASCINT® (capromab pendetide) is indicated as a
diagnostic imaging agent in newly diagnosed patients with biopsy
proven prostate cancer, thought to be clinically localized after
standard diagnostic evaluation and who are thought to be at high
risk for pelvic lymph node metastases. It is not indicated in
patients who are not at high risk. PROSTASCINT is also indicated in
post-prostatectomy patients with a negative or equivocal standard
metastatic evaluation in whom there is a high clinical suspicion of
occult metastatic disease. PROSTASCINT images should be interpreted
only by physicians who have had specific training in PROSTASCINT
image interpretation. Proper patient preparation is mandatory to
obtain optimal images for interpretation (see PRECAUTIONS, Imaging
Precautions in the full prescribing information). Confirmatory
studies should be used in conjunction with PROSTASCINT scan results
to determine appropriate patient management.
This press release describes clinical applications and imaging
performance that differs from that reported in the FDA approved
PROSTASCINT package insert.
A copy of the full prescribing information for PROSTASCINT may
be obtained in the U.S. from EUSA Pharma by calling toll free
800-833-3533, or by visiting the web site at
www.prostascintimaging.com .
About EUSA Pharma Inc.
EUSA Pharma is a rapidly growing transatlantic specialty
pharmaceutical company focused on in-licensing, developing and
marketing late-stage oncology, pain control and critical care
products. The company currently has eight products on the global
market, including Caphosol® (super saturated calcium
phosphate), ProstaScint® (capromab pendetide), Quadramet®
(Samarium 153 lexidronam), Erwinase® (Erwinia L-asparaginase
for injection) and Kidrolase® (E.coli L-asparaginase for
injection), and the antibiotic surgical implant Collatamp® G
(gentamicin impregnated sponge). EUSA also has several products in
late-stage development, notably Collatamp® G topical,
(gentamicin impregnated collagen sponge) and CollaRx®*
(bupivacaine implant).
Founded in 2006, EUSA Pharma is supported by a consortium of
leading life science capital investors, comprising TVM Capital,
Essex Woodlands, 3i, Goldman Sachs, Advent Venture Partners, SV
Life Sciences, NeoMed and NovaQuest. Since its foundation, the
company has raised over $275 million, and completed several
significant transactions, including the acquisitions of Cytogen
Corporation, Talisker Pharma Limited, the French biopharmaceutical
company OPi SA and the European antibiotic and pain control
business of Innocoll Pharmaceuticals Inc. As part of its rapid
growth strategy the company has an established commercial
infrastructure in the US, a pan-European presence covering over 20
countries and a wider distribution network in a further 25
territories. EUSA Pharma plans to continue its aggressive program
of acquisitions and in-licensing, in line with its ambitious target
to become the leading specialty company within its specialist areas
of medical and geographic focus.
For more information please visit http://www.eusapharma.com/.
*CollaRx® is a registered trademark of Innocoll Technologies
Ltd
Source: EUSA Pharma (USA), Inc.
CONTACT: Dr. Taheri Mercedes of EUSA Pharma (USA), Inc.,
+1-215-867-4969, Taheri.mercedes@eusapharma.com
Web Site: http://www.eusapharma.com/
