Vantas Implant Retrieval Study

NCT01013025 | Completed

• 1 other identifier: 303
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; implant retrieval

Outcome Measures

Primary Outcomes (1)

• The number (and percent) of successfully located and removed implants was the primary outcome measure.

  cross-sectional design, data collected at time of explant procedure.

Study Arms (1)

Patients treated with Vantas implant

Patients were enrolled if they had had a Vantas implant placed for treatment of adenocarcinoma of the prostate, and if the patients were scheduled for explant of the implant, and the physician had difficulty locating the implant.

Procedure: Ultrasound or CT or MRI to locate implant

Interventions

Ultrasound or CT or MRI to locate implant PROCEDURE

Scanning methods (eg, ultrasound, CT, or MRI) were used to locate the implant.

Also known as: Vantas

Patients treated with Vantas implant

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study was planned to include approximately 10 patients with locally advanced or metastatic prostate cancer who satisfied the inclusion and exclusion criteria.

You may qualify if:

• Were male patients with adenocarcinoma of the prostate;
• Were age 45 years or older;
• Had received a Vantas® implant;
• Had difficult to locate or non-palpable implant at time of implant retrieval;
• Had the ability to undergo ultrasound, and/or CT, and/or MRI within two weeks of Screening Visit;
• Voluntarily provided Informed Consent prior to the performance of any study-specific procedures.

You may not qualify if:

• Major medical or psychiatric illness that would interfere with return visits; patient not suitable (e.g., noncompliance history) for study in opinion of the Investigator or Sponsor;
• Participated in a clinical trial for an investigational agent within 30 days prior to the Screening Visit (unless enrolled in Protocol 301 Extension).

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

High-Energy Shock Waves; histrelin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 12, 2009
• First Posted: November 13, 2009
• Study Start: July 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: January 2, 2024

Record last verified: 2023-12