Prostatic NeoplasmsPhase 2NCT00568516
Phase II Study of ASP3550 in Patients With Prostate Cancer
A Phase 2 study testing ASP3550 in people with Prostatic Neoplasms, run by Astellas Pharma Inc at 8 sites in Japan.
Trial summary
To assess the effect of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- ASP3550
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 8 sitesJapan
- Study dates
- Oct 2007to Oct 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is a male patient with histologically proven prostate cancer (adenocarcinoma) of all stages
- Is a patient in whom endocrine treatment is indicated. Patients with rising serum PSA after having prostatectomy or radiotherapy performed with curative intention may be included
- Has a serum testosterone level above 1.5 ng/mL at screening
- Has an ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of 0 to 2
Who cannot join
- 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 preceding Screening Visit may be included
- Is being treated with a 5α-reductase inhibitor
- Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months
- Has concurrent or a history of severe asthma (defined as a need for daily treatment with inhalation steroids), anaphylactic reactions, severe urticaria and angioedema
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Study site
Chūbu
Study site
Chugoku
Study site
Hokkaido
Study site
Kansai
Study site
Kanto
Study site
Kyusyu
Study site
Shikoku
Study site
Tōhoku
About this study
Official title: Phase II Study of ASP3550 - A Maintenance-dose Finding Study in Patients With Prostate Cancer
To assess the effect of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer
Read the detailed description
Two doses of ASP3550 were administered to patients with prostate cancer. The primary efficacy variable was the effect of ASP3550 on the maintenance of serum testosterone suppression. In addition, the safety and pharmacokinetics of ASP3550 will be investigated.
- Conditions
- Prostatic Neoplasms
- Being tested
- ASP3550
- Keywords
- ASP3550, Degarelix, Prostate cancer, Prostatic neoplasms
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP3550Drug
Also called Degarelix
subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| 1.Low dose group | Experimental | Not described Receives: Drug: ASP3550 |
| 2.High dose group | Experimental | Not described Receives: Drug: ASP3550 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment
Measured: 1 Year
Secondary outcomes (4)
Proportion of patients with testosterone surge
Measured: 1 Year
Percentage change in serum PSA
Measured: 1 Year
Changes in serum levels of testosterone, LH, FSH and PSA over time
Measured: 1 Year
Time to the recurrence of serum PSA
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568516
- Sponsor's protocol ID
- 3550-CL-0003
- Status last verified
- Oct 2014
- First submitted
- 5 Dec 2007
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of ASP3550 - A Maintenance-dose Finding Study in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT00568516
- Acronym / sponsor ID
- 3550-CL-0003
- Conditions
- Prostatic Neoplasms
- Keywords
- ASP3550, Degarelix, Prostate cancer, Prostatic neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 6 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the effect of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer
Detailed description
Two doses of ASP3550 were administered to patients with prostate cancer. The primary efficacy variable was the effect of ASP3550 on the maintenance of serum testosterone suppression. In addition, the safety and pharmacokinetics of ASP3550 will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.Low dose group | Experimental | Drug: ASP3550 |
| 2.High dose group | Experimental | Drug: ASP3550 |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Is a male patient with histologically proven prostate cancer (adenocarcinoma) of all stages
- Is a patient in whom endocrine treatment is indicated. Patients with rising serum PSA after having prostatectomy or radiotherapy performed with curative intention may be included
- Has a serum testosterone level above 1.5 ng/mL at screening
- Has an ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of 0 to 2
Key exclusion criteria (4 listed)
- 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 preceding Screening Visit may be included
- Is being treated with a 5α-reductase inhibitor
- Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months
- Has concurrent or a history of severe asthma (defined as a need for daily treatment with inhalation steroids), anaphylactic reactions, severe urticaria and angioedema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP3550Also: Degarelixsubcutaneous administration | Drug | 1.Low dose group, 2.High dose group |
Primary outcome
Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment
Time frame: 1 Year
4 secondary outcomes
Proportion of patients with testosterone surge
Time frame: 1 Year
Percentage change in serum PSA
Time frame: 1 Year
Changes in serum levels of testosterone, LH, FSH and PSA over time
Time frame: 1 Year
Time to the recurrence of serum PSA
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
Related trials for Prostatic Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Central Contact study chair
Astellas Pharma Inc
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASP3550 in people with Prostatic Neoplasms, run by Astellas Pharma Inc at 8 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2014.