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Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT01697384 (opens ClinicalTrials.gov in a new tab)Other id301
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Overview

Status
Completed
Phase
Phase 3
Enrollment
138 participants (actual)
Sponsor
Endo USA Inc., a Keenova Therapeutics Company · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
Not stated
Start
Apr 2000
Primary completion
Aug 2003
Completion
Oct 2004
First posted
2 Oct 2012 (estimated)
Last update posted
2 Jan 2024
Conditions
Prostate Cancer · Adenocarcinoma of the Prostate

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200020012002200320042005
  1. Ph 3

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

    NCT01697384

    Apr 2000 to Oct 2004

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • histrelin acetateDrug

Arms1

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 52 weeks

Secondary outcomes(3)

  1. PSA measurements

    Time frame · 52 weeks

  2. Pain measurements

    Time frame · 52 weeks

  3. QoL outcomes

    Time frame · 52 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2006

8 results

Efficacy and safety of histrelin subdermal implant in patients with advanced prostate cancer.

Schlegel et al. 2006The Journal of urologycited by 39

PMID 16515997DOI 10.1016/s0022-5347(05)00649-xPUB-16515997

Full text at the publisher8 results
Publisher pageSee results (8)

Eligibility

Who could join, as posted.

Sex
Male
Age
from 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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