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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 recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by British Columbia Cancer Agency.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Kim Chi, British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT01630967
First received: June 25, 2012
Last updated: June 27, 2012
Last verified: June 2012

June 25, 2012
June 27, 2012
August 2012
December 2013   (final data collection date for primary outcome measure)
50% fall in PSA [ Time Frame: 8 weekly ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01630967 on ClinicalTrials.gov Archive Site
  • Luteinizing hormone (LH) [ Time Frame: 8 weekly ] [ Designated as safety issue: No ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
  • Follicle stimulating hormone (FSH) [ Time Frame: 8 weekly ] [ Designated as safety issue: No ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
  • Testosterone (TT) [ Time Frame: 8 weekly ] [ Designated as safety issue: No ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
  • dehydroepiandrosterone (DHEA) [ Time Frame: 8 weekly ] [ Designated as safety issue: No ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
  • dehydroepiandrosterone-sulfate (DHEA-S) [ Time Frame: 8 weekly ] [ Designated as safety issue: No ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
  • androstenedione (AED) [ Time Frame: 8 weekly ] [ Designated as safety issue: No ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
  • dihydrotestosterone (DHT) [ Time Frame: 8 weekly ] [ Designated as safety issue: No ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
Same as current
Not Provided
Not Provided
 
Efficacy Study of Switching to a Lutenizing Hormone-releasing Hormone (LHRH) Antagonist From a LHRH Agonist to Treat Progressive Castrate Resistant Prostate Cancer (CRPC)
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.

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).

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Neoplasm
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
Experimental: Degarelix
Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression.
Intervention: Drug: Degarelix
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. Epub 2011 Jul 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact: Kim N Chi, MD +1 604 877 6000 ext 2746 kim.chi@bccancer.bc.ca
Canada
 
NCT01630967
BCCA_Deg01
No
Kim Chi, British Columbia Cancer Agency
British Columbia Cancer Agency
Ferring Pharmaceuticals
Principal Investigator: Kim N Chi, MD British Columbia Cancer Agency, Univeristy of British Columbia
British Columbia Cancer Agency
June 2012

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