Clinical trial NCT01545882: A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer
Official title: A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Keywords: prostate
hormone-resistant
degarelix
firmagon
anti-androgens
total androgen blockade
injection
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: PSA Progression
timeFrame: Monthly for 6 months then every 3 months
Secondary outcomes:
measure: Time to Disease progression
timeFrame: Monthly for 6 months then every 3 months
measure: The efficacy of Testosterone, LH and FSH suppression with Degarelix
timeFrame: Monthly for 6 months then every 3 months
measure: The impact of monthly injections of Degarelix on Health Related Quality of Life Issues in patients with prostate cancer
timeFrame: Month 3 and 6 then every 3 months
Other outcomes:
Locations:
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margeret Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital Cancer Centre
name: Shawn Malone, Dr.
role: PRINCIPAL_INVESTIGATOR
References: