Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists (DELAY)
This study is currently recruiting participants.
Verified February 2012 by CMX Research
Sponsor:
CMX Research
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
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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
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 May 19, 2013