Study of Histrelin Subdermal Implant in Patients With Prostate Cancer

NCT01394263 | Completed Phase 3

• 1 other identifier: 302
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Prostate Cancer; Adenocarcinoma of the Prostate

Keywords

prostate cancer; PSA; testosterone suppression

Outcome Measures

Primary Outcomes (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.

  52 weeks

Secondary Outcomes (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.

  52 weeks

Study Arms (2)

Zoladex goserelin implant.

ACTIVE COMPARATOR

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

Drug: Zoladex goserelin implant

Histrelin Acetate implant

EXPERIMENTAL

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.

Drug: Histrelin hydrogel implant

Interventions

Histrelin hydrogel implant DRUG

50 mg histrelin acetate in hyrogel implant

Also known as: Vantas

Histrelin Acetate implant

Zoladex goserelin implant DRUG

goserelin implant injection.

Also known as: Zoladex

Zoladex goserelin implant.

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

histrelin; Goserelin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 14, 2011
• Study Start: May 1, 2000
• Primary Completion: December 1, 2001
• Study Completion: December 1, 2003
• Last Updated: January 2, 2024

Record last verified: 2023-12