A Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer

Last updated: July 3, 2017
Sponsor: Ferring Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Prostate Disorders

Treatment

N/A

Clinical Study ID

NCT02526784
000184
2015-000357-20
  • Ages > 18
  • Male

Study Summary

The purpose of this trial is to compare the severity of ISRs (Injection Site Reactions) following degarelix subcutaneous (s.c.) administrations with two different injection techniques and intramuscular (i.m.) administration in patients with hormone dependent prostate cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged ≥18 years with a diagnosis of adenocarcinoma of the prostate (Gleason graded, allstages) where endocrine treatment is indicated.

  • Caucasian origin.

  • Able to provide written Informed Consent and willing and able to comply with trialprocedures.

  • Body mass index (BMI) between 18.5-30 kg/m2.

  • Has a life expectancy of at least one year.

Exclusion

Exclusion Criteria:

  • Current hormonal management of prostate cancer.

  • Previous endocrine therapy for prostate cancer within 3 months prior to the screeningvisit.

  • Any medical injection therapy that might interfere with degarelix injections.

  • Patients with advanced muscle atrophy or cachexia which in the Investigator's opinionwould preclude or pose risks of complications following ventrogluteal i.m. injectionof degarelix.

  • Any medical condition that could be aggravated or may cause extreme discomfort duringthe trial period or could cause a moderate risk to a patient (significant heart, renalor liver disease).

  • Chronic pain syndrome or any continuous pain reported by the patient that, accordingto the judgement of the Investigator, could limit the evaluation of injection relatedpain.

Study Design

Total Participants: 120
Study Start date:
December 01, 2015
Estimated Completion Date:
June 30, 2017

Connect with a study center

  • Tampereen yliopistollinen sairaala (there may be other sites in this country)

    Tampere,
    Finland

    Site Not Available

  • Groupe Hospitalier Pellegrin Tripode (there may be other sites in this country)

    Bordeaux,
    France

    Site Not Available

  • Universitaetsklinikum Freiburg (there may be other sites in this country)

    Freiburg,
    Germany

    Site Not Available

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