Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists
NCT ID: NCT01366053
Last Updated: 2016-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
125 participants
OBSERVATIONAL
2011-03-31
2015-07-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Prostate Cancer
Males who have been diagnosed with Prostate Cancer and are experiencing PSA rise, while taking androgen agonist therapy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
CMX Research
OTHER
Responsible Party
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Principal Investigators
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Richard Casey, M.D.
Role: PRINCIPAL_INVESTIGATOR
CMX Research
Alvaro Morales, M.D.
Role: PRINCIPAL_INVESTIGATOR
Queens University
Locations
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Exdeo Clinical Research Inc.
Abbotsford, British Columbia, Canada
Southern Interior Medical Research Inc.
Kelowna, British Columbia, Canada
Andreou Research
Surrey, British Columbia, Canada
Dr. Steinhoff Clinical Research
Victoria, British Columbia, Canada
The Male/Female Health and Research Centre
Barrie, Ontario, Canada
Jonathan Giddens Medicine Professional Corporation
Brampton, Ontario, Canada
Brantford Urology Research
Brantford, Ontario, Canada
G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, Canada
Guelph Urology Associates
Guelph, Ontario, Canada
Mor Urology Inc.
Newmarket, Ontario, Canada
Toronto Urology Clinical Study Group
North York, Ontario, Canada
The Fe/Male Health Centres
Oakville, Ontario, Canada
2150935 Ontario Inc.
Owen Sound, Ontario, Canada
643094 Ontario Inc.
Scarborough Village, Ontario, Canada
Stanley Flax Medical Professional Corporation
Toronto, Ontario, Canada
Urology South Shore Research Inc.
Greenfield Park, Quebec, Canada
Urolaval
Laval, Quebec, Canada
Countries
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References
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Fontana D, Mari M, Martinelli A, Boccafoschi C, Magno C, Turriziani M, Maymone SS, Cunico SC, Zanollo A, Montagna G, Frongia M, Jacobellis U. 3-month formulation of goserelin acetate ('Zoladex' 10.8-mg depot) in advanced prostate cancer: results from an Italian, open, multicenter trial. Urol Int. 2003;70(4):316-20. doi: 10.1159/000070142.
Gittelman M, Pommerville PJ, Persson BE, Jensen JK, Olesen TK; Degarelix Study Group. A 1-year, open label, randomized phase II dose finding study of degarelix for the treatment of prostate cancer in North America. J Urol. 2008 Nov;180(5):1986-92. doi: 10.1016/j.juro.2008.07.033. Epub 2008 Sep 17.
Jocham D. Leuprorelin three-month depot in the treatment of advanced and metastatic prostate cancer: long-term follow-up results. Urol Int. 1998;60 Suppl 2:18-24; discussion 35. doi: 10.1159/000056547.
Khan MS, O'Brien A. An evaluation of pharmacokinetics and pharmacodynamics of leuprorelin acetate 3M-depot in patients with advanced and metastatic carcinoma of the prostate. Urol Int. 1998;60(1):33-40. doi: 10.1159/000030200.
Morote J, Orsola A, Planas J, Trilla E, Raventos CX, Cecchini L, Catalan R. Redefining clinically significant castration levels in patients with prostate cancer receiving continuous androgen deprivation therapy. J Urol. 2007 Oct;178(4 Pt 1):1290-5. doi: 10.1016/j.juro.2007.05.129. Epub 2007 Aug 14.
Van Poppel H, Tombal B, de la Rosette JJ, Persson BE, Jensen JK, Kold Olesen T. Degarelix: a novel gonadotropin-releasing hormone (GnRH) receptor blocker--results from a 1-yr, multicentre, randomised, phase 2 dosage-finding study in the treatment of prostate cancer. Eur Urol. 2008 Oct;54(4):805-13. doi: 10.1016/j.eururo.2008.04.065. Epub 2008 May 8.
Zinner NR, Bidair M, Centeno A, Tomera K. Similar frequency of testosterone surge after repeat injections of goserelin (Zoladex) 3.6 mg and 10.8 mg: results of a randomized open-label trial. Urology. 2004 Dec;64(6):1177-81. doi: 10.1016/j.urology.2004.07.033.
Other Identifiers
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CMX-DELAY2010
Identifier Type: -
Identifier Source: org_study_id