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Completed

NCT Number: NCT02526784

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Tampereen yliopistollinen sairaala (there may be other sites in this country), Tampere, Finland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥18 years with a diagnosis of adenocarcinoma of the prostate (Gleason graded, all stages) where endocrine treatment is indicated.
  • Caucasian origin.
  • Able to provide written Informed Consent and willing and able to comply with trial procedures.
  • Body mass index (BMI) between 18.5-30 kg/m2.
  • Has a life expectancy of at least one year.

Exclusion criteria

  • Current hormonal management of prostate cancer.
  • Previous endocrine therapy for prostate cancer within 3 months prior to the screening visit.
  • Any medical injection therapy that might interfere with degarelix injections.
  • Patients with advanced muscle atrophy or cachexia which in the Investigator's opinion would preclude or pose risks of complications following ventrogluteal i.m. injection of degarelix.
  • Any medical condition that could be aggravated or may cause extreme discomfort during the trial period or could cause a moderate risk to a patient (significant heart, renal or liver disease).
  • Chronic pain syndrome or any continuous pain reported by the patient that, according to the judgement of the Investigator, could limit the evaluation of injection related pain.

Treatment and study plan

degarelix

Drug

Other names: Firmagon

Primary outcomes

  1. Difference in the average patient reported injection site pain score between patients receiving the optimised and standard s.c. injections, as well as between patients receiving the i.m. and standard s.c. injections

    Time frame: From baseline to month 6

    Assessed by a 10-graded numeric pain rating scale (0=no pain, 10=worst possible pain)

Secondary outcomes

  1. Patient reported injection site pain scores after degarelix starting dose

    Time frame: From starting dose to 6 days after starting dose

    Assessed by a 10-graded numeric pain rating scale (0=no pain, 10=worst possible pain)

  2. Patient reported injection site pain scores after degarelix maintenance doses

    Time frame: From first maintenance dose (month 1) to 6 days after last maintenance dose (month 6)

    Assessed by a 10-graded numeric pain rating scale (0=no pain, 10=worst possible pain)

  3. Difference in skin colour values between pre- and post-injection

    Time frame: From baseline to month 6

    Average of 4 measurements on skin redness at the injection site using DSM II ColorMeter

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

A Multi-Centre, Open-Label, Randomised Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 18, 2015
Registry last updated
Jul 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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