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

December 21, 2016 updated by: CMX Research

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2S 3N5
        • Exdeo Clinical Research Inc.
      • Kelowna, British Columbia, Canada, V1Y 2H4
        • Southern Interior Medical Research Inc.
      • Surrey, British Columbia, Canada, V3V 1N1
        • Andreou Research
      • Victoria, British Columbia, Canada, V8V 3N1
        • Dr. Steinhoff Clinical Research
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • The Male/Female Health and Research Centre
      • Brampton, Ontario, Canada, L6T 4S5
        • Jonathan Giddens Medicine Professional Corporation
      • Brantford, Ontario, Canada, N3R 4N3
        • Brantford Urology Research
      • Burlington, Ontario, Canada, L7N 3V2
        • G. Kenneth Jansz Medicine Professional Corporation
      • Guelph, Ontario, Canada, N1H 5J1
        • Guelph Urology Associates
      • Newmarket, Ontario, Canada, L3X 1W1
        • Mor Urology Inc.
      • North York, Ontario, Canada, M6A 3B5
        • Toronto Urology Clinical Study Group
      • Oakville, Ontario, Canada, L6H 3P1
        • The Fe/Male Health Centres
      • Owen Sound, Ontario, Canada, N4K 2J1
        • 2150935 Ontario Inc.
      • Scarborough, Ontario, Canada, M1S 4V5
        • 643094 Ontario Inc.
      • Toronto, Ontario, Canada, M2J1V1
        • Stanley Flax Medical Professional Corporation
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H3
        • Urology South Shore Research Inc.
      • Laval, Quebec, Canada, H7G 2E6
        • UroLaval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Two Years after first dose of degarelix.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hormone Levels
Time Frame: Two Years after first dose of degarelix.
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.
PSA Response
Time Frame: Two Years after first dose of degarelix.
To evaluate PSA response (ability of Degarelix to stabilise or reverse PSA progression)
Two Years after first dose of degarelix.
PSA Failure
Time Frame: Two Years after first dose of degarelix.
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.
PSA Doubling Time
Time Frame: Two Years after first dose of degarelix.
To evaluate PSA doubling time.
Two Years after first dose of degarelix.
Time to Metastases
Time Frame: Two Years after first dose of degarelix.
To evaluate how long patients are on degeralix before they develop metastases (non-metastatic patients)
Two Years after first dose of degarelix.
Time to Chemotherapy
Time Frame: Two Years after first dose of degarelix.
Eevaluate how long patients have been on degeralix before initiating chemotherapy.
Two Years after first dose of degarelix.
Time to Anti-Androgen use
Time Frame: Two Years after first dose of degarelix.
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.
Patient Performance Status
Time Frame: Two Years after first dose of degarelix.
To evaluate patient performance status as defined by the Eastern Cooperative Oncology Group (ECOG).
Two Years after first dose of degarelix.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CMX Research

Collaborators

Ferring Pharmaceuticals

Investigators

  • Principal Investigator: Richard Casey, M.D., CMX Research
  • Principal Investigator: Alvaro Morales, M.D., Queens University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

May 30, 2011

First Submitted That Met QC Criteria

June 2, 2011

First Posted (ESTIMATE)

June 3, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 21, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMX-DELAY2010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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