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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 30, 2014