Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer

December 29, 2023 updated by: Endo Pharmaceuticals

Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Advanced Prostate Cancer

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Other outcome measures included serum levels of LH, PSA, as well as non-clinical assessments, eg, WHO Performance Status, pain level assessment, and quality of life questionnaires. Safety was evaluated via adverse events, vital signs, clinical laboratory outcomes, physical examinations, and ECGs. Local tolerability outcomes were also evaluated.

An extension period for the study included annual replacement of the implant until the implant was approved by the FDA (October 12, 2004). Efficacy and safety were followed during the extension period.

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Male Age 45 or older
  • Histologically confirmed adenocarcinoma of the prostate
  • Disease Staging III or IV
  • Clinical indication for androgen suppression therapy
  • Serum testosterone at least 150 ng/dL at screening
  • WHO Performance Scale 0 to 3
  • Life expectancy of at least one year

Key Exclusion Criteria:

  • Bilateral orchiectomy
  • Prior androgen-ablative therapy within past year
  • Second malignancy with 5 years (except adequately treated non-melanomatous skin cancer or superficial bladder cancer)
  • Spinal cord compression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: one histrelin acetate 50 mg implant
The test product was a histrelin acetate 50 mg hydrogel implant surgically placed subdermally into the inner aspect of the upper arm.
Drug: histrelin acetate
52 week implant
Other Names:
  • Vantas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Suppression of testosterone to chemical castration levels (<= 50 ng/dL)
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
PSA measurements
Time Frame: 52 weeks
52 weeks
Pain measurements
Time Frame: 52 weeks
52 weeks
QoL outcomes
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endo Pharmaceuticals

Investigators

  • Study Director: Regulatory Division, Endo Pharmaceuticals (formerly Valera/Indevus Pharmaceuticals)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2000

Primary Completion (Actual)

August 1, 2003

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

July 13, 2011

First Submitted That Met QC Criteria

September 27, 2012

First Posted (Estimated)

October 2, 2012

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 301 (Yasar Calıskan)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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