Prostate CancerDELAYNCT01366053
Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists
An observational study of Prostate Cancer, run by CMX Research at 17 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 125 participants
- Where
- 17 sitesCanada
- Study dates
- Mar 2011to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with prostate cancer failing androgen deprivation therapy can be investigated in this trial.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Canada17 sites
Exdeo Clinical Research Inc.
Abbotsford British Columbia, British Columbia, V2S 3N5
The Male/Female Health and Research Centre
Barrie, Ontario, L4M 7G1
Jonathan Giddens Medicine Professional Corporation
Brampton, Ontario, L6T 4S5
Brantford Urology Research
Brantford, Ontario, N3R 4N3
G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, L7N 3V2
Urology South Shore Research Inc.
Greenfield Park, Quebec, J4V 2H3
Guelph Urology Associates
Guelph, Ontario, N1H 5J1
Southern Interior Medical Research Inc.
Kelowna, British Columbia, V1Y 2H4
Urolaval
Laval, Quebec, H7G 2E6
Mor Urology Inc.
Newmarket, Ontario, L3X 1W1
Toronto Urology Clinical Study Group
North York, Ontario, M6A 3B5
The Fe/Male Health Centres
Oakville, Ontario, L6H 3P1
2150935 Ontario Inc.
Owen Sound, Ontario, N4K 2J1
643094 Ontario Inc.
Scarborough Village, Ontario, M1S 4V5
Andreou Research
Surrey, British Columbia, V3V 1N1
Stanley Flax Medical Professional Corporation
Toronto, Ontario, M2J1V1
Dr. Steinhoff Clinical Research
Victoria, British Columbia, V8V 3N1
About this study
Official title: Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists: A Prospective, Observational, Phase IV Study (DELAY)
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.
Read the 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.
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Androgen Deprivation Therapy, Agonist, Antagonist, PSA Failure, PSA Rise
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer | Males who have been diagnosed with Prostate Cancer and are experiencing PSA rise, while taking androgen agonist therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testosterone Suppression
To evaluate testosterone supression in hormone sensitive prostate cancer patients switched to Degarelix therapy after failing on GnRH agonists
Measured: Two Years after first dose of degarelix.
Secondary outcomes (8)
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
Measured: Two Years after first dose of degarelix.
PSA Response
To evaluate PSA response (ability of Degarelix to stabilise or reverse PSA progression)
Measured: Two Years after first dose of degarelix.
PSA Failure
To evaluate how long patients are on degeralix prior to demonstrating biochemical disease progression (time to PSA failure)
Measured: Two Years after first dose of degarelix.
PSA Doubling Time
To evaluate PSA doubling time.
Measured: Two Years after first dose of degarelix.
Time to Metastases
To evaluate how long patients are on degeralix before they develop metastases (non-metastatic patients)
Measured: Two Years after first dose of degarelix.
Time to Chemotherapy
Eevaluate how long patients have been on degeralix before initiating chemotherapy.
Measured: Two Years after first dose of degarelix.
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
Measured: Two Years after first dose of degarelix.
Patient Performance Status
To evaluate patient performance status as defined by the Eastern Cooperative Oncology Group (ECOG).
Measured: Two Years after first dose of degarelix.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMX Research
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Richard Casey, M.D., Principal investigator, CMX ResearchAlvaro Morales, M.D., Principal investigator, Queens University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366053
- Sponsor's protocol ID
- CMX-DELAY2010
- Acronym
- DELAY
- Status last verified
- Dec 2016
- First submitted
- 30 May 2011
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 12740498Gittelman 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.
PubMed 18801505Jocham 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.
PubMed 9607554Khan 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.
PubMed 9519419Morote 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.
PubMed 17698136Van 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.
PubMed 18538469Zinner 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.
PubMed 15596193
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists: A Prospective, Observational, Phase IV Study (DELAY)
- ClinicalTrials.gov ID
- NCT01366053
- Acronym / sponsor ID
- DELAY / CMX-DELAY2010
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Androgen Deprivation Therapy, Agonist, Antagonist, PSA Failure, PSA Rise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- CMX ResearchUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- Mar 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer | – | –Males who have been diagnosed with Prostate Cancer and are experiencing PSA rise, while taking androgen agonist therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with prostate cancer failing androgen deprivation therapy can be investigated in this trial.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Testosterone Suppression
Time frame: Two Years after first dose of degarelix.
To evaluate testosterone supression in hormone sensitive prostate cancer patients switched to Degarelix therapy after failing on GnRH agonists
8 secondary outcomes
Hormone Levels
Time frame: Two Years after first dose of degarelix.
PSA Response
Time frame: Two Years after first dose of degarelix.
PSA Failure
Time frame: Two Years after first dose of degarelix.
PSA Doubling Time
Time frame: Two Years after first dose of degarelix.
Time to Metastases
Time frame: Two Years after first dose of degarelix.
Time to Chemotherapy
Time frame: Two Years after first dose of degarelix.
Time to Anti-Androgen use
Time frame: Two Years after first dose of degarelix.
Patient Performance Status
Time frame: Two Years after first dose of degarelix.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
- Background: PubMed 12740498Fontana 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.
- Background: PubMed 18801505Gittelman 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.
- Background: PubMed 9607554Jocham 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.
- Background: PubMed 9519419Khan 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.
- Background: PubMed 17698136Morote 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.
- Background: PubMed 18538469Van 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.
- Background: PubMed 15596193Zinner 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Casey, M.D. principal investigator
CMX Research
Alvaro Morales, M.D. principal investigator
Queens University
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by CMX Research at 17 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testosterone Suppression (time frame: Two Years after first dose of degarelix.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01366053, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2016.