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

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ClinicalTrials.gov Identifier: NCT01545882
Recruitment Status : Terminated (Negative study; Principal Investigator chose to prematurely terminate the study.)
First Posted : March 7, 2012
Last Update Posted : July 23, 2013
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Degarelix Phase 2

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer
Study Start Date : May 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Degarelix

Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. The impact of monthly injections of Degarelix on Health Related Quality of Life [ Time Frame: Month 3 and 6 then every 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545882


Locations
Canada, Ontario
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H8L6
Princess Margeret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Shawn Malone, Dr. The Ottawa Hospital Cancer Centre

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01545882     History of Changes
Other Study ID Numbers: 10-059
OTT 10-06 ( Other Identifier: The Ottawa Hospital Cancer Centre )
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: July 23, 2013
Last Verified: July 2013

Keywords provided by Ottawa Hospital Research Institute:
prostate
hormone-resistant
degarelix
firmagon
anti-androgens
total androgen blockade
injection

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Androgens
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs