Clinical trial · Interventional
A Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer
A Multi-Centre, Open-Label, Randomised Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer
NCT02526784CI-TRIAL-00028484completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| degarelix | Drug | Degarelix | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Injection A
- description
- Degarelix s.c. standard injections
- interventionNames
- Drug: degarelix
- type
- EXPERIMENTAL
- label
- Injection B
- description
- Degarelix s.c. optimised injections
- interventionNames
- Drug: degarelix
- type
- EXPERIMENTAL
- label
- Injection C
- description
- Degarelix i.m. injections
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.