Clinical trial · Observational
Vantas Implant Retrieval Study
Phave IV, Multicenter, Open-label Study to Collect VANTAS® Implant Retrieval Data From Patients With Advanced Prostate Cancer and Difficult to Remove Implants
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound or CT or MRI to locate implant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients treated with Vantas implant
- description
- 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.
- interventionNames
- Procedure: Ultrasound or CT or MRI to locate implant
Primary outcomes (1)
- measure
- The number (and percent) of successfully located and removed implants was the primary outcome measure.
- timeFrame
- cross-sectional design, data collected at time of explant procedure.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
References
Publications (0)
Data not yet available