Kit for the Preparation of Indium In 111 Capromab Pendetide
For Intravenous Use Only
ProstaScint® (Capromab Pendetide) is the murine monoclonal antibody, 7E11-C5.3, conjugated to the linker-chelator, glycyl-tyrosyl-(N,-diethylenetriaminepentaacetic acid)-lysine hydrochloride (GYK-DTPA-HCl). The 7E11-C5.3 antibody is of the IgG1, kappa subclass (IgG1K). This antibody is directed against a glycoprotein expressed by prostate epithelium known as Prostate Specific Membrane Antigen (PSMA). The PSMA epitope recognized by monoclonal antibody (MAb) 7E11-C5.3 is located in the cytoplasmic domain. Expression of this glycoprotein has not been demonstrated on any other adenocarcinomas or transitional cell cancers tested. The antibody is produced by serum-free in vitro cultivation of cells, and purified by sequential protein isolation and chromatographic separation procedures.
Each ProstaScint® kit consists of two vials which contain all of the non-radioactive ingredients necessary to produce a single unit dose of Indium In 111 ProstaScint®, an immunoscintigraphic agent for administration by intravenous injection only. The ProstaScint® vial contains 0.5 mg of capromab pendetide in 1 mL of sodium phosphate buffered saline solution adjusted to pH 6; a sterile, pyrogen-free, clear, colorless solution that may contain some translucent particles. The vial of sodium acetate buffer contains 82 mg of sodium acetate in 2 mL of Water for Injection adjusted to pH 5-7 with glacial acetic acid; it is a sterile, pyrogen-free, clear, and colorless solution. Neither solution contains a preservative. Each kit also includes one sterile 0.22 μm Millex® GV filter, prescribing information, and two identification labels.The sodium acetate solution must be added to the sterile, non-pyrogenic high purity Indium In 111 Chloride solution to buffer it prior to radiolabeling ProstaScint®. The immunoscintigraphic agent Indium In 111 Capromab Pendetide (Indium In 111 ProstaScint®) is formed after radiolabeling with Indium In 111.
Indium In 111 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 (e.g. chest x-ray, bone scan, CT scan, or MRI), who are at high-risk for pelvic lymph node metastases (see CLINICAL PHARMACOLOGY, Imaging Performance in Newly-Diagnosed Patients). It is not indicated in patients who are not at high risk.
Indium In 111 ProstaScint® is also indicated as a diagnostic imaging agent in post-prostatectomy patients with a rising PSA and a negative or equivocal standard metastatic evaluation in whom there is a high clinical suspicion of occult metastatic disease. The imaging performance of Indium In 111 ProstaScint® following radiation therapy has not been studied.
The information provided by Indium In 111 ProstaScint® imaging should be considered in conjunction with other diagnostic information. Scans that are positive for metastatic disease should be confirmed histologically in patients who are otherwise candidates for surgery or radiation therapy unless medically contraindicated. Scans that are negative for metastatic disease should not be used in lieu of histological confirmation.
ProstaScint® is not indicated as a screening tool for carcinoma of the prostate nor for readministration for the purpose of assessment of response to treatment.
Media Articles Related to Prostascint (Capromab Pendetide)
Blood Tests May Define Why Treatment Fails in Prostate Cancer
Source: Medscape Hematology-Oncology Headlines [2014.09.25]
A new study has shown how genomic analysis of repeated sampling of biopsies and blood samples may provide a new 'treatment paradigm' in the future.
Medscape Medical News
High-Dose RT Is a 'Conundrum' in Localized Prostate Cancer
Source: Medscape Hematology-Oncology Headlines [2014.09.24]
A major phase 3 trial compared high- and standard-dose radiation therapy in intermediate-risk, localized disease. The results cast doubt on the dose that American practitioners most commonly use.
Medscape Medical News
Should Higher Risk = Earlier Screening for Prostate Cancer?
Source: Medscape Family Medicine Headlines [2014.09.23]
Dr. Gerald Chodak discusses a new study that looked for the best way to screen for prostate cancer in African American men and those with a family history of prostate cancer.
Pioneering Trial of Radiation in Aggressive Prostate Cancer
Source: Medscape Hematology-Oncology Headlines [2014.09.23]
Patients with high-risk prostate cancer should be treated with long-term hormone therapy and high-dose radiation, a new study concludes.
Medscape Medical News
Sexual function preserved following vessel-sparing radiation therapy for prostate cancer
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2014.09.19]
A comparison of five-year sexual function outcomes, as reported by patients treated with external beam radiotherapy (EBRT) versus combination EBRT plus brachytherapy, indicates that the utilization...
Published Studies Related to Prostascint (Capromab Pendetide)
Use of 111in-capromab pendetide immunoscintigraphy to image localized prostate cancer foci within the prostate gland. [2009.09]
PURPOSE: We compared the results of a preoperative (111)In-capromab pendetide scan co-registered with computerized tomography with pathological findings in the surgically excised prostate to determine whether the scan can efficiently detect cancer in the prostate... CONCLUSIONS: The scan did not localize prostate cancer to a particular quadrant based on comparison with radical prostatectomy specimen pathology. The antibody used has affinity for benign and malignant prostatic glands in excised, formalin fixed prostate tissue, which may contribute to low scan specificity in vivo. The scan cannot be used to reliably detect or image cancer foci in the prostate.
Salvage cryosurgical ablation of the prostate for local recurrence after radiation therapy: improved outcomes utilizing a capromab pendetide scan and biopsy algorithm. [2007.12]
PURPOSE: We assessed the efficacy, complications and technical advancements in salvage cryosurgical ablation of the prostate for recurrent prostate cancer after radiation therapy... CONCLUSION: Salvage cryotherapy in experienced hands utilizing third-generation technology provides for excellent biochemical control with minimal morbidity.
Biochemical disease-free survival rates following definitive low-dose-rate prostate brachytherapy with dose escalation to biologic target volumes identified with SPECT/CT capromab pendetide. [2007.01]
CONCLUSION: The data presented here demonstrate the feasibility of performing SPECT/CT BTV dose escalation in a mature series.
Role of ProstaScint for brachytherapy in localized prostate adenocarcinoma. [2004.07]
ProstaScint (CYT-356 or capromab pendetide, Cytogen) is an 111In-labeled monoclonal mouse antibody specific for prostate-specific membrane antigen, a prostate transmembrane glycoprotein that is upregulated in prostate adenocarcinoma...
Clinical utility of indium 111-capromab pendetide immunoscintigraphy in the detection of early, recurrent prostate carcinoma after radical prostatectomy. [2002.02.15]
BACKGROUND: Despite the ability of radical prostatectomy to eradicate prostate carcinoma, biochemical evidence of recurrent prostate carcinoma may be seen in approximately 40% of patients 15 years after they undergo surgery. Localization of recurrent disease after radical prostatectomy is difficult and may greatly influence subsequent clinical management. The authors examined the utility of indium 111 ((111)In)-capromab pendetide immunoscintigraphy to detect recurrent prostate carcinoma radiographically in men with early biochemical evidence of failure (serum prostate specific antigen [PSA] < or = 4.0 ng/mL) and assessed the minimum serum PSA level necessary for imaging recurrent disease... CONCLUSIONS: Capromab pendetide imaging can localize early PSA recurrence and may guide appropriate treatment after patients undergo radical prostatectomy. No minimum serum PSA value was needed to potentially detect radiographic disease after surgery. Further confirmatory studies and long-term follow-up of this cohort documenting response to salvage therapy are needed to validate these imaging findings. Copyright 2002 American Cancer Society. DOI 10.1002/cncr.10337
Clinical Trials Related to Prostascint (Capromab Pendetide)
A Phase I Pilot Study Comparing 123I MIP 1072 Versus 111In Capromab Pendetide in Subjects With Metastatic Prostate Cancer [Recruiting]
This is an open-label study comparing the imaging characteristics of 123-I-MIP-1072 and
ProstaScint® (111-In-capromab pendetide)in patients with metastatic prostate cancer.
Eligible patients will receive a dose of 123-I-MIP-1072 and have imaging studies and safety
assessments (physical examination, vital signs, electrocardiogram, clinical laboratory
tests) performed during the subsequent 24 hours. Two weeks later, patients will return for
additional safety assessments and will receive ProstaScint® if they don't already have a
pre-existing ProstaScint scan. Final assessments will be performed two weeks after the
ProstaScint® scan unless there is a difference between the 123-I-MIP-1072 and ProstaScint®
scans. If this is the case, another dose of 123-I-MIP-1072 will be given 12 weeks later,
and imaging studies repeated.
Evaluation of a Transrectal Scintigraphic Detector(ProxiScanTM) for Detection of Primary Prostate Cancer [Recruiting]
This is a feasibility, exploratory, and proof-of-concept study to evaluate rectal probe
scintigraphy device (ProxiScanTM) to detect PSMA specific radiopharmaceutical agent
(ProstaScint®) in patients with suspected primary prostate cancer. ProxiScanTM is a small
cadmium zinc telluride (CST)-based compact gamma camera the size of a trans-rectal
ultrasound (TRUS) developed by Hybridyne Imaging Technologies, Inc. To explore the adjunctive
benefit/feasibility of PSMA distribution in the normal prostate versus prostate cancer gland
utilizing TRUS and CT/SPECT hybrid imaging, biopsy negative patients will be considered as
normal controls. Prostate cancer sextant biopsy histology results will be correlated with
ProxiScanTM, TRUS, and pelvis planar and SPECT/CT. Our hypothesis is that it will be safe
and feasible to utilize a rectal probe scintigraphy (ProxiScanTM) to detect PSMA specific
ProstaScintÂ® uptake in primary prostate cancer.
FACBC Outcomes for Post Prostatectomy [Recruiting]
Prostate cancer is the most common solid tumor, with approximately 200,000 new cases
diagnosed per year. Several different local therapies are available for treatment, including
surgery and radiotherapy Significant advances have been made in the technical aspects of
surgery and of radiotherapy which have improved both the cancer control outcomes as well as
the morbidity of treatment. Despite these significant advances, approximately 30% of
patients treated with definitive local therapy experience recurrent disease. Recurrent
disease after prostatectomy usually manifests with rising PSA (blood test for prostate
cancer). The PSA level is often of limited use in differentiating local recurrence (ie.
recurrence in the prostate bed) from recurrence outside of the prostate bed (
One PET radiotracer which has shown promise in the staging and restaging of patients with
prostate carcinoma is anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid
(anti-3-[18F]FACBC) which is a synthetic amino acid analog. FACBC demonstrated higher
accuracy compared with 111Indium-capromab-pendetide in the restaging of patients with
suspected recurrent prostate carcinoma.
The major goal in this proposed investigation is to use advanced molecular imaging to better
guide post-prostatectomy decision making, in terms of guiding the decision to deliver
radiotherapy, and in terms of the exact areas treated with radiotherapy.
Investigators will perform a study with 162 patients in whom there is a strong suspicion of
prostate cancer that has returned to the body after having a prostatectomy. Half of these
patients will have radiotherapy decision-making and delivery per the usual routine, and half
of these patients will have the radiotherapy decision and volumes guided by the FACBC test.
The major goal of the investigation is to see whether the FACBC improves the selection and
the cancer control rates of post-surgery patients with a rising PSA who undergo