Clinical trial NCT01630967: Efficacy Study of Switching to a Lutenizing Hormone-releasing Hormone (LHRH) Antagonist From a LHRH Agonist to Treat Progressive Castrate Resistant Prostate Cancer (CRPC)
Official title: A Phase II Single Arm Study of Degarelix in Men With Castrate Resistant Prostate Cancer With a Rising Prostate-Specific Antigen (PSA) Despite LHRH Agonist Therapy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostate Neoplasm
Keywords: castrate resistance
PSA progression
LHRH antagonism
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2012-06-28
Enrollment: 40
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: Men with castrate resistant prostate cancer who are switched from a luteinizing hormone-releasing hormone (LHRH) antagonists from a LHRH agonist will experience a fall in prostate-specific antigen (PSA).

Detailed description: To determine the proportion of patients with castrate resistant Prostate Cancer who have a PSA decline of ≥50% from baseline PSA when switched from an LHRH agonist to an LHRH antagonist.

Eligibility criteria: Inclusion Criteria:

* histologically confirmed adenocarcinoma of the prostate
* currently receiving LHRH agonist
* Anti-androgen oral therapy is permitted but will be discontinued upon enrollment
* PSA \> 2 ng/ml
* rising PSA despite LHRH agonist
* patients may or may not have clinical evidence off metastases. If metastases are present, they must be asymptomatic and in bone or lymph node only
* Prior chemotherapy allowed
* ECOG performance status 0-1

Exclusion Criteria:

* Patients with a history of other active malignancies, except: adequately treated non-melanoma skin cancer, superficial bladder cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 3 years.
* Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including: i)Significant cardiovascular condition including but not limited to: uncontrolled hypertension, unstable angina, significant congestive heart failure or myocardial infarction, deep venous thrombosis, pulmonary embolus or cerebrovascular attack within the last 6 months. ii) History of significant neurological disorder that would impair the ability to obtain consent

Primary outcomes:
measure: 50% fall in PSA
timeFrame: 8 weekly
Secondary outcomes:
measure: Luteinizing hormone (LH)
timeFrame: 8 weekly
measure: Follicle stimulating hormone (FSH)
timeFrame: 8 weekly
measure: Testosterone (TT)
timeFrame: 8 weekly
measure: dehydroepiandrosterone (DHEA)
timeFrame: 8 weekly
measure: dehydroepiandrosterone-sulfate (DHEA-S)
timeFrame: 8 weekly
measure: androstenedione (AED)
timeFrame: 8 weekly
measure: dihydrotestosterone (DHT)
timeFrame: 8 weekly
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
Study officials:
affiliation: British Columbia Cancer Agency, Univeristy of British Columbia
name: Kim N Chi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crawford ED, Tombal B, Miller K, Boccon-Gibod L, Schroder F, Shore N, Moul JW, Jensen JK, Olesen TK, Persson BE. A phase III extension trial with a 1-arm crossover from leuprolide to degarelix: comparison of gonadotropin-releasing hormone agonist and antagonist effect on prostate cancer. J Urol. 2011 Sep;186(3):889-97. doi: 10.1016/j.juro.2011.04.083. Epub 2011 Jul 23.