Know Cancer

forgot password

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

Phase 2
18 Years
Open (Enrolling)
Prostatic Neoplasms

Thank you

Trial Information

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

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

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA Progression


Canada: Health Canada

Study ID:




Start Date:

May 2011

Completion Date:

May 2012

Related Keywords:

  • Prostatic Neoplasms
  • prostate
  • hormone-resistant
  • degarelix
  • firmagon
  • anti-androgens
  • total androgen blockade
  • injection
  • Neoplasms
  • Prostatic Neoplasms