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Trial · Interventional

CompletedPhase 3Registry data

Study of Histrelin Subdermal Implant in Patients With Prostate Cancer

NCTNCT01394263 (opens ClinicalTrials.gov in a new tab)Other id302
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Overview

Status
Completed
Phase
Phase 3
Enrollment
59 participants (actual)
Sponsor
Endo USA Inc., a Keenova Therapeutics Company · Industry
Design
Randomized · Open label (no masking)
Countries
Not stated
Start
May 2000
Primary completion
Dec 2001
Completion
Dec 2003
First posted
14 Jul 2011 (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
20002001200220032004
  1. Ph 3

    Study of Histrelin Subdermal Implant in Patients With Prostate Cancer

    NCT01394263

    May 2000 to Dec 2003

Registry summary

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

This trial was an open-label, multi-national, randomized, parallel treatment, active-control multicenter study in adult males with documented metastatic prostate cancer disease who were judged to be candidates for hormone therapy.

Interventions

  • Histrelin hydrogel implantDrug
  • Zoladex goserelin implantDrug

Arms2

  • Active comparator

    Zoladex goserelin implant.

    Zoladex goserelin implant: D, L-lactic and glycolic acids copolymer. Injected subcutaneously into the upper abdominal wall.

  • Experimental

    Histrelin Acetate implant

    Histrelin hydrogel implant, 3 cm x 3.5 mm, containing 50 mg of histrelin acetate, surgically placed subdermally into the inner aspect of the upper arm.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Suppression of testosterone via the percent of patients whose testosterone was at or below chemical castration levels (<=50 n/dL) through 52 weeks of treatment.

    Time frame · 52 weeks

Secondary outcomes(1)

  1. Secondary efficacy was assessed by serum LH, PSA, and PAP, WHO Performance Status, Pain Level assessment, the National Prostatic Cancer Project (NPCP) assessment for objective clinical status, PSA status, time to disease progression, and QoL.

    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

Studies0

Studies that cite this trial.

No study cites this trial.

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 patients with histologically confirmed adenocarcinoma of the prostate * Disease staging of M1 or apparent failure of the initial definitive therapy (e.g., prostatectomy, radiation, etc.), suggested by either an elevated PSA (5 ng/mL or greater within the previous 28 days), or when below 5ng/mL, rising PSA values (elevation from previous measurement greater than or equal to 0.1 ng/mL on three consecutive measurements at least two weeks apart with at least one of these measurements being within the last 28 days which may include the Screening Visit result, if needed) * Clinically indicated for androgen suppression therapy * Age 45 years or older * Serum testosterone level of 150 ng/dL (5.25 nmol/L) or greater at screening * PSA level of 5ng/mL or greater within the previous 28 days, or an increase in PSA (elevation from previous measurements greater than or equal to 0.1ng/mL on three consecutive measurements at least two weeks apart) Key Exclusion Criteria: * Bilateral orchiectomy * Prior androgen-ablative or systemic corticosteroid therapy within the past year * Second malignancy within five years, except adequately treated nonmelanomatous skin cancer or superficial bladder cancer * Spinal cord compression * Location of vertebral metastases that indicate risk of spinal cord compression during initial treatment period in the opinion of the Investigator * Brain metastasis previously confirmed by CT scan

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