Vantas Implant Retrieval Study

2014-08-27 03:18:02 | BioPortfolio


The main study objective was to collect implant retrieval information in 10 patients using Vantas®, the 50 mg histrelin implant. Patients who had been identified as having a difficult to locate or non-palpable implant were to have been enrolled. Sites were to adhere to the instructions in the Package Insert, which included specialized investigations such as ultrasound, CT, and MRI, to be used for the location and removal of implants.


Up to 50 centers using Vantas, the recently approved histrelin implant as part of their urology practice for treating patients with advanced prostate cancer, were to be identified for participation in this Phase IV post-marketing trial. Up to 10 patients who had been implanted with Vantas at these participating centers, and who had difficult to locate or non-palpable implants at the time of removal, were to be enrolled in this trial. A Screening Visit was to be conducted to consent the patient and to collect basic medical and safety information for patient participation. Upon patient enrollment, up to three subsequent Visits (Visits 1, 2, and 3) were to be conducted (within 2 weeks of the Screening Visit). The investigator was to locate and remove the implant by following the instructions provided in the protocol. Methods for location of the implant included ultrasound, CT, or MRI procedures. The visit at which the implant was successfully located and removed was to be the final study visit for the patient. Upon successful retrieval of the implant or a determination that, per Study Instructions, the implant cannot be located/removed, the study was completed for the patient. No information was to be collected on re-implantation of a new implant. Safety was to be monitored throughout the two week study. Blood samples for testosterone and PSA were only collected at the Screening Visit. The implants removed from the patients were to be returned to Indevus Pharmaceuticals for analysis.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Prostate Cancer


Ultrasound or CT or MRI to locate implant




Endo Pharmaceuticals Solutions Inc.

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:18:02-0400

Clinical Trials [3988 Associated Clinical Trials listed on BioPortfolio]

Ultrasound-Guided Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer Previously Treated With External-Beam Radiation Therapy

RATIONALE: Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. PURPOSE: This phase II trial is studying the side effects and how ...

Ultrasound Targeting for the Lumpectomy Cavity

Accurate targeting of treatment sites should increase local control by radiation therapy for breast-cancer lumpectomy patients. Currently, ultrasound localization is used for prostate canc...

US-CT Fusion for Post Implant Dosimetry

Post implant dosimetry is an essential part of quality assurance after permanent seed prostate brachytherapy. CT imaging is the standard of assessment but due to contouring uncertainties, ...

SmartTarget THERAPY

The purpose of this study is to assess how accurately SmartTarget can direct high intensity focused ultrasound (HIFU) to a pre-defined area (cancer) in the prostate. The current standard ...

Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy

This clinical trial studies an ultrasound-based imaging procedure called elastography using the Aixplorer system in diagnosing prostate cancer in patients undergoing biopsy. Ultrasound is ...

PubMed Articles [16248 Associated PubMed Articles listed on BioPortfolio]

The Ultrasound Characteristics of MRI Suspicious Regions Predict the Likelihood of Clinically Significant Cancer on MRI-Ultrasound Fusion Targeted Biopsy.

To determine whether the presence of an ultrasound hypoechoic region at the site of a MRI region of interest (ROI) results in improved prostate cancer (PCa) detection and predicts clinically significa...

How Would MRI-Targeted Prostate Biopsy Alter Radiation Therapy Approaches in Treating Prostate Cancer?

To determine if MRI/ultrasound fusion-targeted prostate biopsy (TB) would lead to increased recommendations of aggressive radiotherapy treatments for higher risk prostate cancer compared to systematic...

Ga-PSMA PET/CT vs. mpMRI for locoregional prostate cancer staging: correlation with final histopathology.

Prostate-specific membrane antigen (PSMA) positron emission tomography (PET) can be used to locate lesions based on PSMA avidity, however guidelines on its use are limited by its infancy. We aimed to ...

Contrast-Enhanced Ultrasound (CEUS) and Quantitative Perfusion Analysis in Patients with Suspicion for Prostate Cancer.

 The aim of this study was to investigate contrast-enhanced ultrasound (CEUS) parameters acquired by software during magnetic resonance imaging (MRI) US fusion-guided biopsy for prostate cancer (PCa...

The Impact of Positron Emission Tomography with F-Fluciclovine on the Management of Patients with Biochemical Recurrence of Prostate Cancer: Results from the LOCATE Trial.

The prospective, multicenter LOCATE trial assessed the impact of positron emission tomography/computed tomography (PET/CT) with F-fluciclovine on management plans for patients with biochemical recurre...

Medical and Biotech [MESH] Definitions

Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).

A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.

A synthetic retinoid that is used orally as a chemopreventive against prostate cancer and in women at risk of developing contralateral breast cancer. It is also effective as an antineoplastic agent.

Proteins secreted by the prostate gland. The major secretory proteins from the human prostate gland include PROSTATE-SPECIFIC ANTIGEN, prostate-specific acid phosphatase, prostate-specific membrane antigen, and prostate-specific protein-94.

Tumors or cancer of the PROSTATE.

More From BioPortfolio on "Vantas Implant Retrieval Study"

Quick Search


Relevant Topics

Radiology is the branch of medicine that studies imaging of the body; X-ray (basic, angiography, barium swallows), ultrasound, MRI, CT and PET. These imaging techniques can be used to diagnose, but also to treat a range of conditions, by allowing visuali...

Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...

Searches Linking to this Trial