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A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer (OTT 10-06)

This study has been terminated.
(Negative study; Principal Investigator chose to prematurely terminate the study.)
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01545882
First received: March 1, 2012
Last updated: July 22, 2013
Last verified: July 2013

March 1, 2012
July 22, 2013
May 2011
October 2011   (final data collection date for primary outcome measure)
PSA Progression [ Time Frame: Monthly for 6 months then every 3 months ] [ Designated as safety issue: No ]
Blood work will be done once a month during the 6 months of treatment then every 3 months until disease progression or participant withdrawal
PSA Progression
Complete list of historical versions of study NCT01545882 on ClinicalTrials.gov Archive Site
  • Time to Disease progression [ Time Frame: Monthly for 6 months then every 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 3 and 6 then every 3 months ] [ Designated as safety issue: No ]
  • Time to Disease progression
  • The efficacy of Testosterone, LH and FSH suppression with Degarelix
  • The impact of monthly injections of Degarelix on Health Related Quality of Life
Not Provided
Not Provided
 
A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer
A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer

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.

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

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostatic Neoplasms
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.
Other Name: Firmagon
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.
Intervention: Drug: Degarelix
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
July 2013
October 2011   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01545882
10-059, OTT 10-06
No
Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
Not Provided
Principal Investigator: Shawn Malone, Dr. The Ottawa Hospital Cancer Centre
Ottawa Hospital Research Institute
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP