Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy Study of Switching to a Lutenizing Hormone-releasing Hormone (LHRH) Antagonist From a LHRH Agonist to Treat Progressive Castrate Resistant Prostate Cancer (CRPC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01630967
Recruitment Status : Unknown
Verified June 2012 by Kim Chi, British Columbia Cancer Agency.
Recruitment status was:  Not yet recruiting
First Posted : June 28, 2012
Last Update Posted : June 28, 2012
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Kim Chi, British Columbia Cancer Agency

Tracking Information
First Submitted Date  ICMJE June 25, 2012
First Posted Date  ICMJE June 28, 2012
Last Update Posted Date June 28, 2012
Study Start Date  ICMJE August 2012
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
50% fall in PSA [ Time Frame: 8 weekly ]
Proportion of patients with castrate resistant prostate cancer (CRPC) who have a PSA decline of ≥50% from baseline when switched from an LHRH agonist to an LHRH antagonist
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
  • Luteinizing hormone (LH) [ Time Frame: 8 weekly ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
  • Follicle stimulating hormone (FSH) [ Time Frame: 8 weekly ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
  • Testosterone (TT) [ Time Frame: 8 weekly ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
  • dehydroepiandrosterone (DHEA) [ Time Frame: 8 weekly ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
  • dehydroepiandrosterone-sulfate (DHEA-S) [ Time Frame: 8 weekly ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
  • androstenedione (AED) [ Time Frame: 8 weekly ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
  • dihydrotestosterone (DHT) [ Time Frame: 8 weekly ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Neoplasm
Intervention  ICMJE Drug: Degarelix
Standard dosing and schedule for administration of degarelix will be used. 240mg s.c. loading dose, 80mg s.c. monthly maintenance dose.
Other Name: Firmagon
Study Arms  ICMJE Experimental: Degarelix
Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression.
Intervention: Drug: Degarelix
Publications * Crawford ED, Tombal B, Miller K, Boccon-Gibod L, Schröder 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 27, 2012)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01630967
Other Study ID Numbers  ICMJE BCCA_Deg01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kim Chi, British Columbia Cancer Agency
Study Sponsor  ICMJE British Columbia Cancer Agency
Collaborators  ICMJE Ferring Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Kim N Chi, MD British Columbia Cancer Agency, Univeristy of British Columbia
PRS Account British Columbia Cancer Agency
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP