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

Prostatic Neoplasms Clinical Trial

— OTT10-06  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01545882
• Other study ID #: 10-059
• Secondary ID: OTT10-06
• Status: Terminated
• Phase: Phase 2
• Start date: May 2011
• Est. completion date: July 2013

Study information

• Verified date: May 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 2013
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	London Regional Cancer Centre	London	Ontario
Canada	Ottawa Hospital Cancer Centre	Ottawa	Ontario
Canada	Princess Margeret Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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