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


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Testosterone Suppression

Outcome Description:

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

Outcome Time Frame:

Two Years after first dose of degarelix.

Safety Issue:

No

Principal Investigator

Richard Casey, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

CMX Research Inc

Authority:

Canada: Health Canada

Study ID:

CMX-DELAY2010

NCT ID:

NCT01366053

Start Date:

March 2011

Completion Date:

January 2014

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Androgen Deprivation Therapy
  • Agonist
  • Antagonist
  • PSA Failure
  • PSA Rise
  • Prostatic Neoplasms

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