Current partner codePEPTIDESDE
NCT01964170·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

234

Locations

8

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

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

Full detailed description

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.

Interventions

Treatment arms and agents.

DRUG

degarelix

subcutaneous

DRUG

Goserelin

subcutaneous

Timeline

From registration to results.

  1. First posted

    Oct 17, 2013

  2. Study start

    Aug 13, 2013

  3. Primary completion

    Jun 5, 2015

  4. Study completion

    Aug 8, 2016

  5. Results posted

    Not reported

  6. Registry updated

    Oct 31, 2024

Outcomes

What the study measures.

Primary outcomes

Cumulative castration rate of treatment in terms of serum testosterone level

Time frame · Up to one year of the treatment

Secondary outcomes

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

Eligibility

Who can take part.

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

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.

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

Kyushu, Japan

Facility not named

Shikoku, Japan

Facility not named

Tōhoku, Japan

Related trials

More studies on Degarelix.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.