Clinical trial · Interventional
A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD
A Phase IIIb Randomized Study of Intermittent Versus Continuous Androgen Deprivation Therapy Using ELIGARD 22.5 mg 3-month Depot in Subjects With Relapsing and Locally Advanced Prostate Cancer Who Are Responsive to Such Therapy
- 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)
Phase IIIb, Open-label, randomized, controlled multi-centre study. Induction therapy phase for 6 months where all subjects receive 2 ELIGARD depot injections. Those subjects with hormone responsive prostate cancer will be randomized and will receive either intermittent or continuous ELIGARD treatment for 36 months. Following this treatment period, subjects will enter a long-term follow-up period for 48 months.
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 |
|---|---|---|---|
| leuprorelin acetate | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Continuous Androgen Deprivation (CAD)
- interventionNames
- Drug: leuprorelin acetate
- type
- EXPERIMENTAL
- label
- Intermittent Androgen Deprivation (IAD)
- interventionNames
- Drug: leuprorelin acetate
Primary outcomes (1)
- measure
- Time to PSA progression
- timeFrame
- 3 Years
Secondary outcomes (5)
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: At study entry (visit 1): * Written informed consent * Male subjects aged \>=18 and \<80 years old * Locally advanced (stage T3 or T4) prostate cancer or Relapsing prostate cancer following radical prostatectomy or,Relapsing prostate cancer following radiotherapy * Gleason score of \>=6 * ECOG performance status of 0-2. * Life expectancy at least 5 years At randomization (visit 4): * Two successive decreasing serum PSA levels \<=1 ng/ml Exclusion Criteria: At study entry (visit 1): * Any suspected second primary tumors * Evidence of metastatic disease * Other malignancy within the last 5 years except * Acute spinal cord compression, uni- or bilateral ureteric obstruction * Any concurrent biological response modifier therapy * Concurrent chemotherapy * Less than 1 year since any prior neoadjuvant or adjuvant hormonal therapy * Less than 6 months since prior 5-alpha reductase inhibitor treatment * Other concurrent hormonal therapy * Any concurrent radiotherapy * Testosterone at screening \<= 1.7 mM or 50 ng/dL * Clinically significant elevation of serum creatinine or liver enzymes * Hypersensitivity to GnRH or other GnRH analogues or leuprorelin acetate * Hypersensitivity to CASODEXâ 50 mg.
References
Publications (2)
- DERIVEDTombal B, Cornel EB, Persad R, Stari A, Gomez Veiga F, Schulman C. Clinical Outcomes and Testosterone Levels Following Continuous Androgen Deprivation in Patients with Relapsing or Locally Advanced Prostate Cancer: A Post Hoc Analysis of the ICELAND Study. J Urol. 2017 Nov;198(5):1054-1060. doi: 10.1016/j.juro.2017.05.072. Epub 2017 May 25. PMID 28552710
- DERIVEDSchulman C, Cornel E, Matveev V, Tammela TL, Schraml J, Bensadoun H, Warnack W, Persad R, Salagierski M, Gomez Veiga F, Baskin-Bey E, Lopez B, Tombal B. Intermittent Versus Continuous Androgen Deprivation Therapy in Patients with Relapsing or Locally Advanced Prostate Cancer: A Phase 3b Randomised Study (ICELAND). Eur Urol. 2016 Apr;69(4):720-727. doi: 10.1016/j.eururo.2015.10.007. Epub 2015 Oct 29. PMID 26520703