International,Multi-Center,Open Label,Randomized Study Assessing the Safety and Efficacy of a Monthly Dosing Regimen of Ozarelix Versus Goserelin Depot in Men With Prostate Cancer

NCT01252693 | Completed Phase 2

• 1 other identifier: SPI-153-10-1
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of this study is to assess the safety and efficacy of a monthly regimen of ozarelix administered subcutaneously (SC) versus Goserelin depot administered subcutaneously in men with Prostate Cancer. This is an international, multi-center, randomized, open label 84 days study. Men who are at least 18 years of age or older, with histologically proven prostate cancer of all stages, in whom endocrine treatment is indicated will be eligible for study entry.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• To assess the percentage of patients with testosterone <=0.5ng/mL.

  From Day 28 through Day 84, in men receiving Ozarelix versus Goserelin

Secondary Outcomes (1)

• Percentage change in Prostate-Specific Antigen level

  From baseline to day 14 and day 28

Study Arms (2)

Ozarelix

EXPERIMENTAL

Drug: Ozarelix

Goserelin

ACTIVE COMPARATOR

Drug: Goserelin

Interventions

Ozarelix DRUG

Ozarelix Loading dose of 130 mg SC at randomization will be followed by maintenance dosing of 65 mg SC at day 8, 28 and 56.

Ozarelix

Goserelin DRUG

Goserelin depot 3.6 mg at randomization will be followed by 3.6 mg SC on days 28 and 56.

Goserelin

Eligibility Criteria

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

You may qualify if:

• Patients, aged 18 years or older, with histologically proven prostate cancer of any stages, for whom endocrine treatment is indicated.
• Screening testosterone \> 1.5 ng/ml
• Life expectancy of at least 12 months
• ECOG score of ≤ 2
• Patient has reviewed and signed Informed consent form
• Patient understands and is willing to comply with the protocol

You may not qualify if:

• Any hormone therapy prior to study entrance
• Any patient at risk of urinary tract obstruction or spinal cord compression due to potential testosterone surge
• History of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema
• History of hypersensitivity towards any components of the study drug
• History or presence of any other malignancy other than treated squamous cell /basal cell carcinoma of the skin within the last five years
• ECG at screening showing QTc \>450 ms, or family history of long QT syndrome
• Abnormal laboratory results which in the judgment of the investigator would affect the patient's health or the outcome of the trial
• - Has a clinically significant medical condition (other than prostate cancer) including but not limited to: renal, hematological, gastrointestinal, endocrine, cardiac, neurological or psychiatric disease, alcohol or drug abuse or any other condition that may affect the patient's health or the outcome of the trial as judged by the investigator
• Taking Class IA or Class III antiarrhythmic medication
• Has an intellectual incapacity or language barrier precluding adequate understanding or co-operation
• Has received investigational drug within the last 28 days before the Screening visit or longer if considered to possibly influence the outcome of this trial
• Has previously participated in any Ozarelix trials
• Is part of an ongoing trial.

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (3)

The Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

Location

Urology San Antonio Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

ozarelix; 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 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 3, 2010
• Study Start: November 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: May 1, 2015
• Last Updated: October 5, 2021

Record last verified: 2021-09

Locations

US (3)