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

NCT01366053 | Completed

• 1 other identifier: CMX-DELAY2010
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Androgen Deprivation Therapy; Agonist; Antagonist; PSA Failure; PSA Rise

Outcome Measures

Primary Outcomes (1)

• Testosterone Suppression

  To evaluate testosterone supression in hormone sensitive prostate cancer patients switched to Degarelix therapy after failing on GnRH agonists

  Two Years after first dose of degarelix.

Secondary Outcomes (8)

• Hormone Levels

  Two Years after first dose of degarelix.

• PSA Response

  Two Years after first dose of degarelix.

• PSA Failure

  Two Years after first dose of degarelix.

• PSA Doubling Time

  Two Years after first dose of degarelix.

• Time to Metastases

  Two Years after first dose of degarelix.

Study Arms (1)

Prostate Cancer

Males who have been diagnosed with Prostate Cancer and are experiencing PSA rise, while taking androgen agonist therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CMX Research: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (17)

Exdeo Clinical Research Inc.

Abbotsford, British Columbia, V2S 3N5, Canada

Location

Southern Interior Medical Research Inc.

Kelowna, British Columbia, V1Y 2H4, Canada

Location

Andreou Research

Surrey, British Columbia, V3V 1N1, Canada

Location

Dr. Steinhoff Clinical Research

Victoria, British Columbia, V8V 3N1, Canada

Location

The Male/Female Health and Research Centre

Barrie, Ontario, L4M 7G1, Canada

Location

Jonathan Giddens Medicine Professional Corporation

Brampton, Ontario, L6T 4S5, Canada

Location

Brantford Urology Research

Brantford, Ontario, N3R 4N3, Canada

Location

G. Kenneth Jansz Medicine Professional Corporation

Burlington, Ontario, L7N 3V2, Canada

Location

Guelph Urology Associates

Guelph, Ontario, N1H 5J1, Canada

Location

Mor Urology Inc.

Newmarket, Ontario, L3X 1W1, Canada

Location

Toronto Urology Clinical Study Group

North York, Ontario, M6A 3B5, Canada

Location

The Fe/Male Health Centres

Oakville, Ontario, L6H 3P1, Canada

Location

2150935 Ontario Inc.

Owen Sound, Ontario, N4K 2J1, Canada

Location

643094 Ontario Inc.

Scarborough Village, Ontario, M1S 4V5, Canada

Location

Stanley Flax Medical Professional Corporation

Toronto, Ontario, M2J1V1, Canada

Location

Urology South Shore Research Inc.

Greenfield Park, Quebec, J4V 2H3, Canada

Location

Urolaval

Laval, Quebec, H7G 2E6, Canada

Location

Related Publications (7)

• 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.

  PMID: 12740498 BACKGROUND

• 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.

  PMID: 18801505 BACKGROUND

• 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.

  PMID: 9607554 BACKGROUND

• 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.

  PMID: 9519419 BACKGROUND

• 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.

  PMID: 17698136 BACKGROUND

• 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.

  PMID: 18538469 BACKGROUND

• 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.

  PMID: 15596193 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Richard Casey, M.D.

  CMX Research

  PRINCIPAL INVESTIGATOR

• Alvaro Morales, M.D.

  Queens University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2011
• First Posted: June 3, 2011
• Study Start: March 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 22, 2016

Record last verified: 2016-12

Locations

CA (17)