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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by CMX Research.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
CMX Research
ClinicalTrials.gov Identifier:
NCT01366053
First received: May 30, 2011
Last updated: February 2, 2012
Last verified: February 2012

May 30, 2011
February 2, 2012
March 2011
October 2013   (final data collection date for primary outcome measure)
Testosterone Suppression [ Time Frame: Two Years after first dose of degarelix. ] [ Designated as safety issue: No ]
To evaluate testosterone supression in hormone sensitive prostate cancer patients switched to Degarelix therapy after failing on GnRH agonists
Same as current
Complete list of historical versions of study NCT01366053 on ClinicalTrials.gov Archive Site
  • Hormone Levels [ Time Frame: Two Years after first dose of degarelix. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    To evaluate PSA response (ability of Degarelix to stabilise or reverse PSA progression)
  • PSA Failure [ Time Frame: Two Years after first dose of degarelix. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    To evaluate PSA doubling time.
  • Time to Metastases [ Time Frame: Two Years after first dose of degarelix. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    To evaluate patient performance status as defined by the Eastern Cooperative Oncology Group (ECOG).
Same as current
Not Provided
Not Provided
 
Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists
Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists: A Prospective, Observational, Phase IV Study (DELAY)

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with prostate cancer failing androgen deprivation therapy can be investigated in this trial.

Prostate Cancer
Not Provided
Prostate Cancer
Males who have been diagnosed with Prostate Cancer and are experiencing PSA rise, while taking androgen agonist therapy.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
January 2014
October 2013   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact: Aaron Park, M.Sc. 905-338-1078 ext 226 apark@cmxres.com
Contact: Richard Casey, M.D. 905-338-3130 rcasey@cmxres.com
Canada
 
NCT01366053
CMX-DELAY2010
No
CMX Research
CMX Research
Ferring Pharmaceuticals
Principal Investigator: Richard Casey, M.D. CMX Research Inc
Principal Investigator: Alvaro Morales, M.D. Queens University
CMX Research
February 2012

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