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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)

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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Prostate Neoplasm Drug: Degarelix Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Degarelix

Arms and Interventions
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Arm Intervention/treatment
Experimental: Degarelix
Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Luteinizing hormone (LH) [ Time Frame: 8 weekly ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

  2. Follicle stimulating hormone (FSH) [ Time Frame: 8 weekly ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

  3. Testosterone (TT) [ Time Frame: 8 weekly ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

  4. dehydroepiandrosterone (DHEA) [ Time Frame: 8 weekly ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

  5. dehydroepiandrosterone-sulfate (DHEA-S) [ Time Frame: 8 weekly ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

  6. androstenedione (AED) [ Time Frame: 8 weekly ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

  7. dihydrotestosterone (DHT) [ Time Frame: 8 weekly ]
    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630967


Contacts
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Contact: Kim N Chi, MD +1 604 877 6000 ext 2746 kim.chi@bccancer.bc.ca

Locations
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Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z4E6
Sponsors and Collaborators
British Columbia Cancer Agency
Ferring Pharmaceuticals
Investigators
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Principal Investigator: Kim N Chi, MD British Columbia Cancer Agency, Univeristy of British Columbia
More Information
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Publications of Results:

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Responsible Party: Kim Chi, Associate Professor of Medicine, University of British Columbia, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01630967    
Other Study ID Numbers: BCCA_Deg01
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012
Keywords provided by Kim Chi, British Columbia Cancer Agency:
castrate resistance
PSA progression
LHRH antagonism
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases