A Phase 3 interventional study of degarelix and Goserelin in Prostate Cancer, sponsored by Astellas Pharma Inc. Completed at 8 sites in Japan. Open to male participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by Astellas Pharma Inc · Phase 3, Interventional, and Treatment
To compare the efficacy and safety of ASP3550 to goserelin acetate in patients with prostate cancer.
This study consists of two parts. The purpose of PART 1 is to test non-inferiority of ASP3550 to goserelin acetate with respect to the cumulative castration rate in terms of serum testosterone when ASP3550 or goserelin acetate is administered for one-year in patients with prostate cancer.
The patients assigned to receive ASP3550 and completed the treatment in PART 1 are eligible for the treatment in PART 2, and will receive ASP3550 maintenance dose subcutaneously for additional term. The long-term safety, efficacy and PK of the continued ASP3550 treatment will be assessed in PART 2.
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 234 is above the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.
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Exclusion Criteria:
Part 1 for 1 year treatment and Part 2 for an extended period of treatment
Drug: degarelix
part 1 for 1 year treatment
Drug: Goserelin
subcutaneous
Also known as: ASP3550
subcutaneous
Cumulative castration rate of treatment in terms of serum testosterone level
Time frame: Up to one year of the treatment
Proportion of castrated subjects in terms of serum testosterone level
Time frame: Up to one year of the treatment
Proportion of castrated subjects in terms of serum testosterone level
Time frame: Baseline and Days 3, 7, and 28
Changes in serum levels of prostate-specific antigen (PSA) over time
Time frame: Up to one year of the treatment
Safety assessed by the incidence of adverse events
Time frame: up to the end of treatment. approximately for 2 years
Plan to share: Yes — Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Inc