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Trial · Interventional

CompletedPhase 3Registry data

A Study to Compare the Effect of ASP3550 With Goserelin in Patients With Prostate Cancer

NCTNCT01964170 (opens ClinicalTrials.gov in a new tab)Other id3550-CL-0010
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
234 participants (actual)
Sponsor
Astellas Pharma Inc · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Japan

Start
13 Aug 2013
Primary completion
5 Jun 2015
Completion
8 Aug 2016
First posted
17 Oct 2013 (estimated)
Last update posted
31 Oct 2024
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014201520162017
  1. Ph 3

    A Study to Compare the Effect of ASP3550 With Goserelin in Patients With Prostate Cancer

    NCT01964170

    13 Aug 2013 to 8 Aug 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

To compare the efficacy and safety of ASP3550 to goserelin acetate in patients with prostate cancer.

Interventions

  • degarelixDrug
  • GoserelinDrug

Arms2

  • Experimental

    ASP3550 PART 1 and PART 2

    Part 1 for 1 year treatment and Part 2 for an extended period of treatment

  • Active comparator

    Goserelin

    part 1 for 1 year treatment

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Cumulative castration rate of treatment in terms of serum testosterone level

    Time frame · Up to one year of the treatment

Secondary outcomes(4)

  1. Proportion of castrated subjects in terms of serum testosterone level

    Time frame · Up to one year of the treatment

  2. Proportion of castrated subjects in terms of serum testosterone level

    Time frame · Baseline and Days 3, 7, and 28

  3. Changes in serum levels of prostate-specific antigen (PSA) over time

    Time frame · Up to one year of the treatment

  4. Safety assessed by the incidence of adverse events

    Time frame · up to the end of treatment. approximately for 2 years

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2018

11 results

Efficacy and safety of 3-month dosing regimen of degarelix in Japanese subjects with prostate cancer: A phase III study.

Ozono et al. 2018Cancer sciencecited by 19

PMID 29624800PMC5989846DOI 10.1111/cas.13600PUB-29624800

Free to read · publisher termsCC BY-NC11 results
Read at sourceSee results (11)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • 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

Eligibility

Who could join, as posted.

Sex
Male
Age
from 20 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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