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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)

This study is not yet open for participant recruitment.
Verified June 2012 by British Columbia Cancer Agency
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
History of Changes
  Purpose

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 Intervention Phase
Prostate Neoplasm
 Drug: Degarelix
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630967

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

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

Publications:

Responsible Party: Kim Chi, Associate Professor of Medicine, University of British Columbia, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01630967     History of Changes
Other Study ID Numbers: BCCA_Deg01
Study First Received: June 25, 2012
Last Updated: June 27, 2012
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by British Columbia Cancer Agency:
castrate resistance
PSA progression
LHRH antagonism

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 21, 2013