Current partner codePEPTIDESDE
NCT01261572·Phase 2·INTERVENTIONAL

Study to Find Maintenance Dose for Periodic Administration of ASP3550

Status

Completed

Phase

Phase 2

Enrollment

155

Locations

8

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

To find effective doses of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer.

Full detailed description

ASP3550 is administered periodically to patients with prostate cancer. The primary efficacy variable is the effect of ASP3550 on the maintenance of serum testosterone suppression. In addition, the safety and pharmacokinetics of ASP3550 will be investigated.

Interventions

Treatment arms and agents.

DRUG

degarelix

periodic injection

Timeline

From registration to results.

  1. First posted

    Dec 16, 2010

  2. Study start

    Oct 12, 2010

  3. Primary completion

    Apr 24, 2012

  4. Study completion

    Apr 24, 2012

  5. Results posted

    Not reported

  6. Registry updated

    Oct 31, 2024

Outcomes

What the study measures.

Primary outcomes

Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time

Time frame · Baseline and for one year

Secondary outcomes

Changes in serum level of testosterone over time

Time frame · Baseline and for one year

Changes in serum level of Luteinizing Hormone (LH) over time

Time frame · Baseline and for one year

Changes in serum level of Follicle Stimulating Hormone (FSH) over time

Time frame · Baseline and for one year

Changes in serum level of Prostate Specific Antigen (PSA) over time

Time frame · Baseline and for one year

Time to the recurrence of serum PSA

Time frame · For one year

Safety evaluated by the incidence of Adverse Events (AEs), physical exam and results of lab tests

Time frame · One year

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
Not reported
Sex
MALE
Healthy volunteers
No

Inclusion Criteria: * Histologically proven prostate cancer (adenocarcinoma) of all stages * A patient in whom endocrine treatment is indicated. Patients with rising serum PSA after having prostatectomy or radiotherapy performed with curative intention * Serum testosterone level above 2.2 ng/mL * An ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of 0 to 2 * Serum PSA level above 2 ng/mL Exclusion Criteria: * Previous or present endocrine treatment for prostate cancer. However, patients who have undergone neoadjuvant/adjuvant endocrine therapy for a maximal duration of 6 months and in whom prostatectomy or radiotherapy was terminated at least 6 months * Treated with a 5α-reductase inhibitor * A candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months * Concurrent or a history of severe liver disease * Abnormal ECG such as long QTc * A patient receiving ASP3550 in past times * Administered drug in another clinical study or a post-market clinical study in the 28 days prior to the study

Study locations

8 registered sites.

Japan. Showing up to 24 locations stored in the fast local snapshot.

Facility not named

Chugoku, Japan

Facility not named

Chūbu, Japan

Facility not named

Hokkaido, Japan

Facility not named

Kansai, Japan

Facility not named

Kantou, Japan

Facility not named

Kyusyu, Japan

Facility not named

Shuku, Japan

Facility not named

Tōhoku, Japan

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Degarelix.

Related PeptideStat pages

Put the record in context.

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