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

Prostate Cancer Clinical Trial

— DELAY  

Official title:

Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists: A Prospective, Observational, Phase IV Study (DELAY)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366053
• Other study ID #: CMX-DELAY2010
• Status: Completed
• Phase: N/A
• First received: May 30, 2011
• Last updated: December 21, 2016
• Start date: March 2011
• Est. completion date: July 2015

Study information

• Verified date: December 2016
• Source: CMX Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Canada	Exdeo Clinical Research Inc.	Abbotsford	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	Urology South Shore Research Inc.	Greenfield Park	Quebec
Canada	Guelph Urology Associates	Guelph	Ontario
Canada	Southern Interior Medical Research Inc.	Kelowna	British Columbia
Canada	Urolaval	Laval	Quebec
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	Ontario
Canada	Andreou Research	Surrey	British Columbia
Canada	Stanley Flax Medical Professional Corporation	Toronto	Ontario
Canada	Dr. Steinhoff Clinical Research	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
CMX Research	Ferring Pharmaceuticals

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Morote J, Orsola A, Planas J, Trilla E, Raventós CX, Cecchini L, Catalán 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Hormone Levels	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	Two Years after first dose of degarelix.	No
Secondary	PSA Response	To evaluate PSA response (ability of Degarelix to stabilise or reverse PSA progression)	Two Years after first dose of degarelix.	No
Secondary	PSA Failure	To evaluate how long patients are on degeralix prior to demonstrating biochemical disease progression (time to PSA failure)	Two Years after first dose of degarelix.	No
Secondary	PSA Doubling Time	To evaluate PSA doubling time.	Two Years after first dose of degarelix.	No
Secondary	Time to Metastases	To evaluate how long patients are on degeralix before they develop metastases (non-metastatic patients)	Two Years after first dose of degarelix.	No
Secondary	Time to Chemotherapy	Eevaluate how long patients have been on degeralix before initiating chemotherapy.	Two Years after first dose of degarelix.	No
Secondary	Time to Anti-Androgen use	Evaluate how long patients are on degeralix before initiating anti-androgen use as well as response to anti-androgen use	Two Years after first dose of degarelix.	No
Secondary	Patient Performance Status	To evaluate patient performance status as defined by the Eastern Cooperative Oncology Group (ECOG).	Two Years after first dose of degarelix.	No