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

Sponsor

Ottawa Hospital Research Institute (Other)

Overall Status

Terminated

CT.gov ID

NCT01545882

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

1.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

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 1, 2011

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

PSA Progression [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

Time to Disease progression [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	London Regional Cancer Centre	London	Ontario	Canada	N6A 4L6
2	Ottawa Hospital Cancer Centre	Ottawa	Ontario	Canada	K1H8L6
3	Princess Margeret Hospital	Toronto	Ontario	Canada	M5G 2M9