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Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists (DELAY)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01366053
First Posted: June 3, 2011
Last Update Posted: December 22, 2016
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.
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
CMX Research
  Purpose

This Phase IV observational trial is intended to identify patients who are failing GnRH agonist therapy as evidenced by a rising PSA and who have yet to initiate secondary manoeuvres involving antiandrogens. This group may include both non-metastatic as well as metastatic patients. The trial will determine if these patients will benefit from switching to Degarelix. It will assess the effect of Degarelix's direct mode of action on androgen levels and whether continuous use of Degarelix improves disease progression.

As per the CUA Guidelines for the Management of CRPC, because the androgen receptor remains active in most patients who have developed castration resistant disease, it is recommended that ADT should be continued (LEVEL 3, GRADE C). Therefore, it is logical to continue patients on Degarelix throughout the castrate resistant period. This will allow for the gathering of data that is currently unknown within this setting, such as the effect of combined treatment with antiandrogens as well as chemotherapy and other castrate resistant treatments.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists: A Prospective, Observational, Phase IV Study (DELAY)

Resource links provided by NLM:


Further study details as provided by CMX Research:

Primary Outcome Measures:
  • Testosterone Suppression [ Time Frame: Two Years after first dose of degarelix. ]
    To evaluate testosterone supression in hormone sensitive prostate cancer patients switched to Degarelix therapy after failing on GnRH agonists


Secondary Outcome Measures:
  • Hormone Levels [ Time Frame: Two Years after first dose of degarelix. ]
    To evaluate testosterone, bio available testosterone (calculated), prostate serum antigen (PSA), luteinizing hormone (LH) , follicle-stimulating hormone (FSH), dihydrotestosterone (DHT) and dehydroepiandrosterone (DHEA) before and after switching to Degarelix and over time

  • PSA Response [ Time Frame: Two Years after first dose of degarelix. ]
    To evaluate PSA response (ability of Degarelix to stabilise or reverse PSA progression)

  • PSA Failure [ Time Frame: Two Years after first dose of degarelix. ]
    To evaluate how long patients are on degeralix prior to demonstrating biochemical disease progression (time to PSA failure)

  • PSA Doubling Time [ Time Frame: Two Years after first dose of degarelix. ]
    To evaluate PSA doubling time.

  • Time to Metastases [ Time Frame: Two Years after first dose of degarelix. ]
    To evaluate how long patients are on degeralix before they develop metastases (non-metastatic patients)

  • Time to Chemotherapy [ Time Frame: Two Years after first dose of degarelix. ]
    Eevaluate how long patients have been on degeralix before initiating chemotherapy.

  • Time to Anti-Androgen use [ Time Frame: Two Years after first dose of degarelix. ]
    Evaluate how long patients are on degeralix before initiating anti-androgen use as well as response to anti-androgen use

  • Patient Performance Status [ Time Frame: Two Years after first dose of degarelix. ]
    To evaluate patient performance status as defined by the Eastern Cooperative Oncology Group (ECOG).


Enrollment: 125
Study Start Date: March 2011
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Prostate Cancer
Males who have been diagnosed with Prostate Cancer and are experiencing PSA rise, while taking androgen agonist therapy.

Detailed Description:

This trial will include hormone sensitive prostate cancer patients switched to Degarelix therapy after failing on GnRH agonists but prior to use of secondary hormonal treatments such as antiandrogens. The purpose of this trial is to determine the effect of Degarelix's direct mode of action on androgen levels and whether continuous use of Degarelix improves disease progression.

This is an open-label, multi-centre, Phase IV observational trial with s.c. injections of Degarelix one-month depot in patients with advanced prostate cancer.

The visit frequency is once a month (28-day intervals), with eCRF data entry at every 4 months. All patients will be treated with a one-month starting dose followed by 23 monthly maintenance doses for a duration of 672 days. The primary endpoints will be evaluated after 24 treatment months.

In total, 25 visits are scheduled for all patients.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with prostate cancer failing androgen deprivation therapy can be investigated in this trial.
Criteria

Inclusion Criteria:

  • Able to read and write, understand instructions related to trial procedures and give written informed consent before any trial-related activity is performed
  • Histologically confirmed adenocarcinoma of the prostate (prostate cancer)
  • Currently under hormonal management of prostate cancer with a GnRH agonist
  • Confirmed biochemical PSA progression on GnRH agonist therapy, defined as ≥50% increase in PSA between 2 measurements, taken at least 1 week apart
  • PSA ≥1.0 ng/ml
  • ECOG score ≤2
  • Able and willing to participate in the full duration of the clinical trial
  • Male patient aged 18 years or older
  • Life expectancy of at least 12 months

Exclusion Criteria:

  • Prior treatment with chemotherapy, radiopharmaceuticals, estrogen, ketoconazole or other secondary hormonal treatments such as antiandrogens except for induction phase (<3 months)
  • History of dermatitis, lupus, eczema, psoriasis affecting area used for Degarelix injections
  • Allergy to Degarelix or its components
  • Has a clinically significant disorder (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator
  • Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy.
  • Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema
  • Has a mental incapacity or language barrier precluding adequate understanding or co operation
  Contacts and Locations
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): NCT01366053


Locations
Canada, British Columbia
Exdeo Clinical Research Inc.
Abbotsford, British Columbia, Canada, V2S 3N5
Southern Interior Medical Research Inc.
Kelowna, British Columbia, Canada, V1Y 2H4
Andreou Research
Surrey, British Columbia, Canada, V3V 1N1
Dr. Steinhoff Clinical Research
Victoria, British Columbia, Canada, V8V 3N1
Canada, Ontario
The Male/Female Health and Research Centre
Barrie, Ontario, Canada, L4M 7G1
Jonathan Giddens Medicine Professional Corporation
Brampton, Ontario, Canada, L6T 4S5
Brantford Urology Research
Brantford, Ontario, Canada, N3R 4N3
G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, Canada, L7N 3V2
Guelph Urology Associates
Guelph, Ontario, Canada, N1H 5J1
Mor Urology Inc.
Newmarket, Ontario, Canada, L3X 1W1
Toronto Urology Clinical Study Group
North York, Ontario, Canada, M6A 3B5
The Fe/Male Health Centres
Oakville, Ontario, Canada, L6H 3P1
2150935 Ontario Inc.
Owen Sound, Ontario, Canada, N4K 2J1
643094 Ontario Inc.
Scarborough, Ontario, Canada, M1S 4V5
Stanley Flax Medical Professional Corporation
Toronto, Ontario, Canada, M2J1V1
Canada, Quebec
Urology South Shore Research Inc.
Greenfield Park, Quebec, Canada, J4V 2H3
Urolaval
Laval, Quebec, Canada, H7G 2E6
Sponsors and Collaborators
CMX Research
Ferring Pharmaceuticals
Investigators
Principal Investigator: Richard Casey, M.D. CMX Research
Principal Investigator: Alvaro Morales, M.D. Queens University
  More Information

Publications:

Responsible Party: CMX Research
ClinicalTrials.gov Identifier: NCT01366053     History of Changes
Other Study ID Numbers: CMX-DELAY2010
First Submitted: May 30, 2011
First Posted: June 3, 2011
Last Update Posted: December 22, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by CMX Research:
Prostate Cancer
Androgen Deprivation Therapy
Agonist
Antagonist
PSA Failure
PSA Rise

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Deslorelin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action