Clinical trial · Interventional
A Study of Degarelix in Patients With Prostate Cancer
A Randomized, Controlled, Open-Label Study Investigating the Safety and Efficacy of Degarelix Given Intermittently vs Continuous Androgen Deprivation Therapy With Lupron or Degarelix in Patients With Prostate Cancer With Prior Treatment Failure After Localized Treatment
NCT00928434CI-TRIAL-00025121completedPhase 3Results postedClinicalTrials.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 study was to see if giving Degarelix every month for 7 months then stop treatment for 7 months (intermittent therapy) would show a reduction of negative effects of androgen deprivation therapy by increasing the quality of life while keeping prostate specific antigen (PSA) levels suppressed.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Degarelix | Drug | Degarelix | ALIAS |
| Leuprolide | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- DI (Degarelix Intermittent)
- description
- Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered. During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
- interventionNames
- Drug: Degarelix
- type
- EXPERIMENTAL
- label
- DC (Degarelix Continuous)
- description
- Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years or older. * Raising PSA after prior treatment failure of localized prostate cancer. * Has a histological confirmed non-metastatic cancer of the prostate (Gleason graded) based on the most current biopsy. * Has a screening testosterone within normal range (≥1.5 ng/mL). * Has Eastern Cooperative Oncology Group score of ≤2. * Bone scan or CT scan report documenting no evidence of metastasis to the bone or internal organs. * Life expectancy of at least 15 months. Exclusion Criteria: * Taken hormone therapy in the last 6 months prior to entering this study. * Being treated with 5-alpha reductase inhibitor at time of enrolment and remained on a stable dose throughout the trial. * Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema. * Has hypersensitivity towards any component of the study drug. * Has a previous history or presence of another malignancy other than prostate cancer or treated squamous/basal cell carcinoma of the skin within the last five years. * Has abnormal laboratory results which in the judgement of the Investigator would affect the patient's health or the outcome of the trial. * Has a clinically significant medical condition (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 an intellectual incapacity or language barriers precluding adequate understanding or co-operation. * Has received an investigational drug within the last 28 days before the Screening visit or longer if considered to possibly influence the outcome of the current trial. * Has received ketoconazole or diflucan in the last 28 days preceding the Screening Visit. * Has previously participated in any Degarelix trial. * Is part of an ongoing trial.
References
Publications (1)
- DERIVEDZengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2. PMID 34350976