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
  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. ] [ Designated as safety issue: No ]
    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. ] [ 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).


Estimated Enrollment: 75
Study Start Date: March 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: October 2013 (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

Ages Eligible for Study:   18 Years and older
Genders 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
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: NCT01366053

Contacts
Contact: Aaron Park, M.Sc. 905-338-1078 ext 226 apark@cmxres.com
Contact: Richard Casey, M.D. 905-338-3130 rcasey@cmxres.com

Locations
Canada, British Columbia
Dr. George Vrabec Recruiting
Abbotsford, British Columbia, Canada, V2S 3N5
Contact: Reena Tut    604-851-5668    reenatut@exdeo.ca   
Principal Investigator: George Vrabec, MD         
Southern Interior Medical Research Inc. Recruiting
Kelowna, British Columbia, Canada, V1Y 2H4
Contact: Joe Husch    250-763-3842    dr.tkinahan@shawcable.com   
Principal Investigator: Thomas J. Kinahan, M.D.         
Andreou Research Recruiting
Surrey, British Columbia, Canada, V3V 1N1
Contact: Dr. Cal Andreou    604-583-2271    andreou@telus.net   
Contact: Sue Badri    604-583-2271    sue.badri@telus.net   
Principal Investigator: Dr. Cal Andreou         
Dr. Steinhoff Clinical Research Recruiting
Victoria, British Columbia, Canada, V8V 3N1
Contact: Catherine Douglas    250-388-0840    catherine@gsteinhoff.com   
Principal Investigator: Gary Steinhoff, M.D.         
Canada, Ontario
The Male/Female Health and Research Centre Recruiting
Barrie, Ontario, Canada, L4M 7G1
Contact: Judy Cannon    705-727-0551    judymalehealth@bmts.com   
Principal Investigator: Joseph Zadra, M.D., F.R.C.S         
Dr. Stanley Flax Recruiting
Brampton, Ontario, Canada, L6T 3J1
Contact: Tracy Hobbins    905-791-4529    flaxstan@hotmail.com   
Principal Investigator: Stanley Flax, M.D.         
Dr. Jonathan Giddens Recruiting
Brampton, Ontario, Canada, L6T 4S5
Contact: Anna Krijan    905-874-0092 ext 6    annakrijan@gmail.com   
Principal Investigator: Jonathan Giddens, MD         
Brantford Urology Research Recruiting
Brantford, Ontario, Canada, N3R 4N3
Contact: Nora Leung    519-753-9221    noraleung@rogers.com   
Principal Investigator: Wilson Leung, M.D., F.R.C.S         
G. Kenneth Jansz Medicine Professional Corporation Recruiting
Burlington, Ontario, Canada, L7N 3V2
Contact: Linda Hager    905-681-3030    lhager@bellnet.ca   
Principal Investigator: Ken Jansz, M.D.         
Dr. Eric Hirshberg Recruiting
Guelph, Ontario, Canada, N1H 5J1
Contact: Susanne Lake    519-824-7272    guelphurology@bellnet.ca   
Principal Investigator: Eric Hirshberg, MD         
Dr. Morrie Liquornik Recruiting
Newmarket, Ontario, Canada, L3X 1W1
Contact: Diane Stone    905-853-7468    morurology@rogers.com   
Principal Investigator: Morrie Liquornik, MD         
Toronto Urology Clinical Study Group Recruiting
North York, Ontario, Canada, M6A 3B5
Contact: Shelley Burton    416-256-9606    tuscg@hotmail.com   
Principal Investigator: Jack Barkin, MD         
Dr. Richard Casey Recruiting
Oakville, Ontario, Canada, L6H 3P1
Contact: Djordje Adanja    905-338-3130    djoka54@yahoo.com   
Principal Investigator: Richard Casey         
Dr. Todd Webster Recruiting
Owen Sound, Ontario, Canada, N4K 2J1
Contact: Jean Hawken    519-370-2266    jhawken@sympatico.ca   
Sub-Investigator: Todd Webster, M.D., F.R.C.S.         
Dr. Allan Abramovitch Recruiting
Scarborough, Ontario, Canada, M1S 4V5
Contact: Dr. Allan Abramovitch    416-754-1019    amfs1@look.ca   
Contact: Polina Schvarts    416-754-1019    polina.shvarts17@gmail.com   
Principal Investigator: Dr. Allan Abramovitch         
Canada, Quebec
Urology South Shore Research Recruiting
Greenfield Park, Quebec, Canada, J4V 2H3
Contact: Carol Paris    450-671-2945    ussr@bellnet.ca   
Contact: Chrystele Marchand    450-671-2945    ussr@bellnet.ca   
Principal Investigator: Lorne Aaron, M.D         
Polyclinique Med Concorde Recruiting
Laval, Quebec, Canada, H7G 2E6
Contact: Jane Bell    450-667-5310    urolaval@hotmail.com   
Principal Investigator: Dr. Jean Simard         
Sponsors and Collaborators
CMX Research
Ferring Pharmaceuticals
Investigators
Principal Investigator: Richard Casey, M.D. CMX Research Inc
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
Study First Received: May 30, 2011
Last Updated: February 2, 2012
Health Authority: Canada: Health Canada

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
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014