Clinical trial · Interventional
A Study to Compare the Effect of ASP3550 With Goserelin in Patients With Prostate Cancer
ASP3550 Phase III Study - An Open-Label, Active-Controlled, Parallel-Arm Study, Comparing ASP3550 With Goserelin Acetate in Patients With Prostate Cancer -
NCT01964170CI-TRIAL-00082100completedPhase 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)
To compare the efficacy and safety of ASP3550 to goserelin acetate in patients with 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 (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ASP3550 PART 1 and PART 2
- description
- Part 1 for 1 year treatment and Part 2 for an extended period of treatment
- interventionNames
- Drug: degarelix
- type
- ACTIVE_COMPARATOR
- label
- Goserelin
- description
- part 1 for 1 year treatment
- interventionNames
- Drug: Goserelin
Primary outcomes (1)
- measure
- Cumulative castration rate of treatment in terms of serum testosterone level
- timeFrame
- Up to one year of the treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Male patient with histologically confirmed prostate cancer (adenocarcinoma). * Patient in whom endocrine treatment is indicated. Patient having undergoing prostatectomy or radiotherapy with curative intention and has a rising serum PSA (PSA ≥ 2 ng/mL at screening) may be included. * Has a serum testosterone level above 2.2 ng/mL at screening. * Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2 at screening. * Has a serum PSA ≥ 2 ng/mL at screening. * Has a life expectancy of at least 12 months. Exclusion Criteria: * Previous or present endocrine treatment for prostate cancer. Example: surgical castration, GnRH agonists, GnRH antagonists, antiandrogens or oestrogens, and 5α-reductase inhibitors. * Received a 5α-reductase inhibitor within 25 weeks preceding screening. * Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months. * Has concurrent or a history of poorly controlled severe asthma, anaphylactic reactions, severe urticaria or angioedema. * Has hypersensitivity towards mannitol. * Has a marked prolongation of QT/QTc interval (two consecutive increases to \>450 ms in QTc interval at retest) at screening. * Has concurrent or a history of a disease (heart failure, hypokalemia, a family history of QT prolongation syndrome, etc.) that may induce Torsade de Pointes.
References
Publications (2)
- 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
- DERIVEDOzono S, Tsukamoto T, Naito S, Horie S, Ohashi Y, Uemura H, Yokomizo Y, Fukasawa S, Kusuoka H, Akazawa R, Saito M, Akaza H. Efficacy and safety of 3-month dosing regimen of degarelix in Japanese subjects with prostate cancer: A phase III study. Cancer Sci. 2018 Jun;109(6):1920-1929. doi: 10.1111/cas.13600. Epub 2018 May 23. PMID 29624800