A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer

Overview

This study is being offered to patients who have hormone resistant prostate cancer (HRPC). This means that their prostate cancer is no longer responding to standard hormonal therapy.

The purpose of this study is to determine whether Degarelix will be able to stop the PSA from rising in patients with hormone resistant prostate cancer.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2011

Detailed Description

This is a phase II study of a GnRH antagonist drug, Degarelix, for use in hormone resistant prostate cancer patients who have had biochemical PSA progression despite the use of total androgen blockade therapy. Patients will receive at least six monthly injections of Degarelix unless the patient shows radiographic or symptomatic disease progression, intolerable toxicity or decides to withdraw from the study. Patients will be evaluated for measures of efficacy, toxicity and disease progression during treatment and afterwards until radiologically confirmed metastatic disease progression or until the patient is removed from the study.

Overall objective:

The efficacy of Degarelix as a treatment for HRPC will be evaluated

Interventions

  • Drug: Degarelix
    • Treatment will consist of a starting dose of 240mg injected subcutaneously (s.c) and monthly s.c. maintenance doses of 80mg for a total duration of 6 months.

Arms, Groups and Cohorts

  • Experimental: Degarelix
    • Degarelix treatment will consist of a starting dose of 240mg injected subcutaneously (s.c) and monthly s.c. maintenance doses of 80mg for a total duration of 6 months.

Clinical Trial Outcome Measures

Primary Measures

  • PSA Progression
    • Time Frame: Monthly for 6 months then every 3 months
    • Blood work will be done once a month during the 6 months of treatment then every 3 months until disease progression or participant withdrawal

Secondary Measures

  • Time to Disease progression
    • Time Frame: Monthly for 6 months then every 3 months
    • Blood work will be done once a month during the 6 months of treatment then every 3 months until disease progression or participant withdrawal
  • The efficacy of Testosterone, LH and FSH suppression with Degarelix
    • Time Frame: Monthly for 6 months then every 3 months
    • Blood work will be done once a month during the 6 months of treatment then every 3 months until disease progression or participant withdrawal
  • The impact of monthly injections of Degarelix on Health Related Quality of Life Issues in patients with prostate cancer
    • Time Frame: Month 3 and 6 then every 3 months
    • The EPIC-26 Expanded Prostate Cancer Index Composite is used to measure quality of life issues in patients with prostate cancer. The questionnaire will be done months 3 and 6 then every 3 months

Participating in This Clinical Trial

Inclusion Criteria

  • Prior trial of total androgen blockade
  • Confirmed biochemical PSA progression on agonist therapy, defined as ≥ 50% increase in PSA between 2 measurements, taken at least 1 week apart. In patients that are currently on total androgen blockade (LHRH agonist plus non-steroidal anti-androgen) there must be a trial withdrawal of androgen receptor antagonists to ensure that there is no PSA response (6 weeks for bicalutamide and 4 weeks for flutamide or nilutamide).
  • Radiologically confirmed non-metastatic disease within 90 days of registration based on negative chest radiographs, CT Scan Abdomen/Pelvis and Bone scan
  • ECOG ≤ 2
  • Age ≥ 18 years
  • Serum testosterone of ≤ 50 mg/dl
  • PSA ≥ 2.0 ng/ml
  • White blood cell count ≥ 3000/mm3
  • Platelets ≥ 100,000/mm3
  • Serum creatinine ≤ 1.5 x upper limits of normal
  • Bilirubin ≤ 1.5 x upper limits of normal
  • Alanine transaminase ≤ 1.25 x upper limits of normal
  • Estimated life expectancy of at least 12 months
  • Able and willing to sign informed consent

Exclusion Criteria

  • Prior treatment with chemotherapy, radiopharmaceuticals, estrogen, PC-SPES, ketoconazole or other second line hormonal therapy (other than non-steroidal anti-androgens or Androcur)
  • Known allergy to GnRH agonists or antagonists
  • Previous treatment with Degarelix
  • Major surgery within 4 weeks of registration
  • Grade ≥ 3 peripheral neuropathy
  • Severe, active co-morbidity such as unstable angina, congestive heart failure or myocardial infarction within the last 6 months or congenital long QT syndrome
  • Acute deep vein thrombosis or pulmonary embolism
  • Taking anti-arrhythmia medication
  • Second malignancy other than non-melanoma skin cancer unless disease free ≥ 5 years.
  • Prior orchiectomy for prostate cancer
  • PSA > 100 ng/mL

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ottawa Hospital Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Shawn Malone, Dr., Principal Investigator, The Ottawa Hospital Cancer Centre

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.