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)
Early Prostate Cancer Diagnoses Continue to Fall in U.S.: Study
Source: MedicineNet Prostate Cancer Specialty [2016.08.19]
Title: Early Prostate Cancer Diagnoses Continue to Fall in U.S.: Study
Category: Health News
Created: 8/18/2016 12:00:00 AM
Last Editorial Review: 8/19/2016 12:00:00 AM
ADT for Prostate Cancer May Increase Death Risk in Black Men
Source: Medscape Hematology-Oncology Headlines [2016.08.17]
Androgen deprivation therapy may result in an increased risk for death among black men with good-risk prostate cancer, a new study finds.
Medscape Medical News
Radical treatment and examination combined can halve mortality from prostate cancer
Source: Prostate / Prostate Cancer News From Medical News Today [2016.08.10]
Men with very high-risk prostate cancer, who are treated at hospitals with a high proportion of administered radical local treatment (radiotherapy or prostatectomy), only have half of the mortality...
A Patient's Journey: Sometimes It's Not All About Prostate Cancer
Source: MedPage Today Oncology/Hematology [2016.08.10]
(MedPage Today) -- Howard Wolinsky had an unexpected detour in his active surveillance journey
Prostate Cancer Symptoms, Tests, Treatments
Source: MedicineNet Benign Prostatic Hyperplasia Specialty [2016.08.08]
Title: Prostate Cancer Symptoms, Tests, Treatments
Created: 12/1/2010 5:22:00 PM
Last Editorial Review: 8/8/2016 12:00:00 AM
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 [Completed]
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 ProstaScintÂ®
scans. If this is the case, another dose of 123-I-MIP-1072 will be given 12 weeks later,
and imaging studies repeated.
Prostate Cancer Imaging With Radioactive Tracer and Ultrasound Detector Compared to MRI and ProstaScint [Enrolling by invitation]
This is a small study to determine if probe, similar to an ultrasound probe, can detect
prostate cancer more specifically than other imaging studies in patients with a positive
prostate cancer biopsy.
Comparison of PET With [89Zr]-Df-IAb2M and [111In]-Capromab Pendetide in the Detection of Prostate Cancer Pre-Prostatectomy [Recruiting]
The purpose of this study is to compare the diagnostic performance of [89Zr]-Df-IAB2M PET/CT
with that of [111In]-capromab pendetide as an immuno PET tracer in the detection of prostate
cancer pre-prostatectomy as confirmed by pathology.
Individuals participating in this study will have a [111In]-capromab pendetide scan, as well
as a PET scan following the injection of [89Zr]-Df-IAB2M.
Evaluation of a Transrectal Scintigraphic Detector(ProxiScanTM) for Detection of Primary Prostate Cancer [Active, not 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.
Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer [Completed]
The current study involves a novel and aggressive therapeutic approach for patients'
prostate cancer. In addition, the investigators propose to administer hormonal therapy to
patients with an especially high risk: those with initial Gleason scores of > 6, PSA > 10
ng/ml, T3/T4 primary tumors, and those found to be node positive (N+). The use of hormonal
therapy in these specific settings correlates with our current standard of care. IMRT is
better able to spare and protect normal tissues from receiving radiation than 3-D conformal
RT. The radiotherapy would be followed by continued hormonal therapy for a total of 6
months in those who have one of the following Gleason 7 and PSA 10-20 and as per the
previous version of this trial, 1 year similar to that delivered by the EORTC for higher
risk patients, (those with initial Gleason scores of > 8, PSA > 20 ng/ml, or T3/T4 tumors).
Those found to be N(+) would have the hormonal therapy continued indefinitely or until
disease progression occurred in a manner analogous to the Messing et. al. series in
prostatectomy patients. The goals are to develop and administer a program of treatment that
includes the most recent developments in imaging, integrating data from both the CT scan and
the ProstaScint scan to optimize prostate cancer RT. The CT scan will be used for staging
and to determine the exact location of the entire prostate which will receive a reasonable
dose of RT. The ProstaScint will be used to assess the spread of disease to lymph nodes as
well as to determine the exact location of the tumor within the prostate gland. This region
will then be boosted to a tumorcidal dose. The investigators then plan to monitor the
toxicity and outcome of this treatment. The investigators expect that this program of
radioimmunoguided IMRT will likely result in similar or less toxicity and increased cure
rates when compared to conventional radiotherapy and standard IMRT programs.
Page last updated: 2016-08-19