NCT02526784

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at below P25 for phase_3 prostate-cancer

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_3 prostate-cancer

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 5, 2017

Status Verified

July 1, 2017

Enrollment Period

1.4 years

First QC Date

August 17, 2015

Last Update Submit

July 3, 2017

Conditions

Prostate Cancer

Outcome Measures

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

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

    From baseline to month 6

Secondary Outcomes (3)

  • Patient reported injection site pain scores after degarelix starting dose

    From starting dose to 6 days after starting dose

  • Patient reported injection site pain scores after degarelix maintenance doses

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

  • Difference in skin colour values between pre- and post-injection

    From baseline to month 6

Study Arms (3)

Injection A

ACTIVE COMPARATOR

Degarelix s.c. standard injections

Drug: degarelix

Injection B

EXPERIMENTAL

Degarelix s.c. optimised injections

Drug: degarelix

Injection C

EXPERIMENTAL

Degarelix i.m. injections

Drug: degarelix

Interventions

degarelixDRUG
Also known as: Firmagon
Injection AInjection BInjection C

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Tampere, Finland

Location

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

Bordeaux, France

Location

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

Freiburg im Breisgau, Germany

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2015

First Posted

August 18, 2015

Study Start

December 1, 2015

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

July 5, 2017

Record last verified: 2017-07

Locations

FR(1)FI(1)DE(1)