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OpenTrials
Completed

NCT Number: NCT01697384

Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men 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.

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Key information

Conditions

Prostate Cancer Adenocarcinoma of the Prostate Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Salivary Gland Adenoma, Pleomorphic Urogenital Diseases Urogenital Neoplasms

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Histrelin Acetate

Drug

52 week implant

Other names: Vantas

Primary outcomes

  1. Suppression of testosterone to chemical castration levels (<= 50 ng/dL)

    Time frame: 52 weeks

Secondary outcomes

  1. PSA measurements

    Time frame: 52 weeks

  2. Pain measurements

    Time frame: 52 weeks

  3. QoL outcomes

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2003
Study completion
2004
First posted
Oct 2, 2012
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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