A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer (OTT10-06)

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 Overview

• Status: Terminated
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Drug: Degarelix

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
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4L6
      • London Regional Cancer Centre
    • Ottawa, Ontario, Canada, K1H8L6
      • Ottawa Hospital Cancer Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margeret Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Firmagon

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Disease progression	Blood work will be done once a month during the 6 months of treatment then every 3 months until disease progression or participant withdrawal	Monthly for 6 months then every 3 months
The efficacy of Testosterone, LH and FSH suppression with Degarelix	Blood work will be done once a month during the 6 months of treatment then every 3 months until disease progression or participant withdrawal	Monthly for 6 months then every 3 months
The impact of monthly injections of Degarelix on Health Related Quality of Life Issues in patients with prostate cancer	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	Month 3 and 6 then every 3 months

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Shawn Malone, Dr., The Ottawa Hospital Cancer Centre

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (Estimate): March 7, 2012

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: prostate; injection; hormone-resistant; degarelix; firmagon; anti-androgens; total androgen blockade
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 10-059; OTT10-06 (Other Identifier: The Ottawa Hospital Cancer Centre)