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Vantas (Histrelin Acetate Implant) - Summary

 
 



VANTAS SUMMARY

Vantas™ (histrelin implant) is a sterile non-biodegradable, diffusion-controlled reservoir drug delivery system designed to deliver histrelin continuously for 12 months upon subcutaneous implantation. The Vantas implant contains 50 mg of histrelin acetate. Histrelin acetate is a synthetic nonapeptide analogue of the naturally occurring gonadotropin releasing hormone (GnRH) or luteinizing hormone releasing hormone (LH-RH). The sterile Vantas implantation device (provided with the implant) is used to insert the implant subcutaneously in the inner aspect of the upper arm. After 12 months, the implant must be removed. At the time the implant is removed, another implant may be inserted to continue therapy.

Vantas is indicated in the palliative treatment of advanced prostate cancer .


See all Vantas indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Vantas (Histrelin Implant)

Pomegranate Juice for Prostate Cancer Prevention? Study Says…
Source: Medscape Hematology-Oncology Headlines [2015.08.28]
Should clinicians recommend pomegranate juice or extract to men after local therapy for prostate cancer?
Medscape Urology

PET imaging detects fast-growing prostate cancer
Source: MRI / PET / Ultrasound News From Medical News Today [2015.08.21]
PSMA-based PET to distinguish benign prostate lesions and prostate cancerA molecular imaging biomarker is able to detect fast-growing primary prostate cancer and distinguish it from benign...

New approach to decades old treatment yields increased survival for some prostate cancer patients
Source: Endocrinology News From Medical News Today [2015.08.07]
For more than 60 years, the standard of care for patients with prostate cancer fueled by androgen hormones that has spread to other parts of the body has been androgen deprivation therapy (ADT).

New biomarker identified in breast and prostate cancers holds promise for treating disease
Source: Prostate / Prostate Cancer News From Medical News Today [2015.08.07]
Discovery may aid clinicians in identifying patients who will respond better to common chemotherapy drugsCedars-Sinai researchers have identified a novel genetic biomarker responsible for the...

Combo Treatment May Boost Survival With Advanced Prostate Cancer
Source: MedicineNet Hormone Therapy Specialty [2015.08.06]
Title: Combo Treatment May Boost Survival With Advanced Prostate Cancer
Category: Health News
Created: 8/5/2015 12:00:00 AM
Last Editorial Review: 8/6/2015 12:00:00 AM

more news >>

Published Studies Related to Vantas (Histrelin Implant)

Long-term efficacy and tolerability of once-yearly histrelin acetate subcutaneous implant in patients with advanced prostate cancer. [2011.08.18]
Study Type - Therapy (individual cohort) Level of Evidence 2b What's known on the subject? and What does the study add? Androgen deprivation therapy with a gonadotropin-releasing hormone agonist is an effective option for the palliative treatment of advanced prostate cancer. This study demonstrated the safety and efficacy of the histrelin acetate implant over successive one year treatment cycles for up to four years in an open-label extension trial. OBJECTIVE: * To evaluate the efficacy and tolerability of a once-yearly histrelin implant during an open-label extension of a pivotal study... CONCLUSIONS: * The once-yearly histrelin implant maintained testosterone suppression for repeated treatment cycles and was generally well tolerated. * The histrelin implant provides a clinically attractive option for long-term androgen deprivation therapy in patients with advanced prostate cancer seeking fewer office visits and repeated injections. (c) 2011 THE AUTHORS. BJU INTERNATIONAL (c) 2011 BJU INTERNATIONAL.

Analysis of testosterone suppression in men receiving histrelin, a novel GnRH agonist for the treatment of prostate cancer. [2010.08]
CONCLUSION: The GnRH agonist histrelin successfully suppressed testosterone over the entire study period. This effect was measured across a number of different clinical definitions of PSA response and clinical risk. The GnRH agonist therefore offers an effective therapy option in hormone treatment of prostate cancer.

Free alpha-subunit is the most sensitive marker of gonadotropin recovery after treatment of central precocious puberty with the histrelin implant. [2010.06]
BACKGROUND: Gonadotropin free alpha-subunit (FAS) levels paradoxically increase during GnRH agonist (GnRHa) treatment of central precocious puberty (CPP). The histrelin implant suppresses gonadotropins and estradiol (E(2)) levels for 1 yr, but effects on FAS have not been described. OBJECTIVES: We aimed to determine whether FAS levels remain elevated during treatment with the implant, to assess the dynamics of FAS after removal, and to ascertain the reliability of FAS for monitoring gonadotropin secretion... CONCLUSIONS: Compared to LH, FSH, and E(2), FAS responds more rapidly to implant removal and represents the most sensitive indicator of gonadotropin recovery after histrelin implant treatment.

Histrelin: in advanced prostate cancer. [2010.03.26]
Histrelin is a gonadotropin-releasing hormone agonist available in a diffusion-controlled reservoir drug delivery system for subcutaneous implantation. The subcutaneous histrelin implant provided sustained suppression of serum testosterone, luteinizing hormone (LH) and prostate-specific antigen levels for up to 1 year in patients with advanced prostate cancer in two phase II or III trials...

Drug-induced liver injury caused by the histrelin (Vantus) subcutaneous implant. [2010.01]
Drug-induced liver injury (DILI) is the leading cause of acute hepatic failure in the United States... The case of a patient with liver injury following a subcutaneous histrelin (Vantus) implant as therapy for advanced prostate cancer is presented.

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Clinical Trials Related to Vantas (Histrelin Implant)

Histrelin Subcutaneous Implant in Children With Central Precocious Puberty [Completed]
The purpose of this study is to follow and collect additional medical and developmental information on children after histrelin subcutaneous implant therapy is discontinued.

Prospective Multicentre Non-interventional Study of VANTAS� for the Treatment of Patients With Advanced Prostate Cancer [Completed]
The aim of this non-interventional (observational) study is to document, in collaboration with established urologists in Scandinavia, experience gained from routine use of Vantas for the treatment of patients with advanced prostate cancer. In this observational study particular attention will be directed to treatment duration, quality of life and patient and physician acceptance of the medicinal product for long-term therapy. Patient-based measurement parameters such as quality of life and degree of satisfaction will allow registration of information that extends beyond the clinical parameters. The knowledge gathered will enable patient acceptance of long-term therapy to be evaluated. Clinical outcome will also be documented by measuring serum testosterone and prostate specific antigen (PSA) levels.

Vantas Implant Retrieval Study [Completed]
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.

Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer [Completed]
Objective was to evaluate the efficacy and safety of the histrelin acetate subdermal implant (originally versus Lupron Depot-3 Month) in male patients with advanced prostate cancer during 52 weeks of treatment with the implant. After consultation w/ FDA, design was modified to eliminate the Lupron arm and continued the study as an open-label non-randomized study. Primary endpoint was testosterone suppression, as assessed by the percent of patients whose testosterone indicated chemical castration levels (<=50 ng/dL) through 52 weeks of treatment with an implant.

Study of Histrelin Subdermal Implant in Patients With Prostate Cancer [Completed]
This trial was an open-label, multi-national, randomized, parallel treatment, active-control multicenter study in adult males with documented metastatic prostate cancer disease who were judged to be candidates for hormone therapy.

more trials >>


Page last updated: 2015-08-28

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