Prostatic NeoplasmsPhase 2NCT01261572
Study to Find Maintenance Dose for Periodic Administration of ASP3550
A Phase 2 study testing degarelix in people with Prostatic Neoplasms, run by Astellas Pharma Inc at 8 sites in Japan.
Trial summary
To find effective doses 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?
- degarelix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 8 sitesJapan
- Study dates
- 12 Oct 2010to 24 Apr 2012
- 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
- 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
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
- 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
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
Kantou
Study site
Kyusyu
Study site
Shuku
Study site
Tōhoku
About this study
Official title: ASP3550 Phase II Study - A Maintenance-Dose-Finding Study of Three-Month Depot in Patients With Prostate Cancer -
To find effective doses of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer.
Read the 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.
- Conditions
- Prostatic Neoplasms
- Being tested
- degarelix
- Keywords
- Prostatic neoplasms, Degarelix, ASP3550, Prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
degarelixDrug
Also called ASP3550
periodic injection
| Study group | Role | What they receive |
|---|---|---|
| High dose group | Experimental | ASP3350 high dose Receives: Drug: degarelix |
| Low dose group | Experimental | ASP3350 low dose Receives: Drug: degarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time
Measured: Baseline and for one year
Secondary outcomes (6)
Changes in serum level of testosterone over time
Measured: Baseline and for one year
Changes in serum level of Luteinizing Hormone (LH) over time
Measured: Baseline and for one year
Changes in serum level of Follicle Stimulating Hormone (FSH) over time
Measured: Baseline and for one year
Changes in serum level of Prostate Specific Antigen (PSA) over time
Measured: Baseline and for one year
Time to the recurrence of serum PSA
Measured: For one year
Safety evaluated by the incidence of Adverse Events (AEs), physical exam and results of lab tests
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study start12 Oct 2010
- Primary completion24 Apr 2012
- Study completion24 Apr 2012
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
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261572
- Sponsor's protocol ID
- 3550-CL-0009
- Status last verified
- Oct 2024
- First submitted
- 1 Dec 2010
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- 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/.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASP3550 Phase II Study - A Maintenance-Dose-Finding Study of Three-Month Depot in Patients With Prostate Cancer -
- ClinicalTrials.gov ID
- NCT01261572
- Acronym / sponsor ID
- 3550-CL-0009
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostatic neoplasms, Degarelix, ASP3550, Prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2010 (actual)
- Primary completion
- 24 Apr 2012 (actual)
- Study completion
- 24 Apr 2012 (actual)
- First posted
- 16 Dec 2010 (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 find effective doses of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose group | Experimental | Drug: degarelixASP3350 high dose |
| Low dose group | Experimental | Drug: degarelixASP3350 low dose |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 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
- 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
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 |
|---|---|---|
| degarelixAlso: ASP3550periodic injection | Drug | High dose group, Low dose group |
Primary outcome
Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time
Time frame: Baseline and for one year
6 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
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 31 Oct 2024.
- Individual participant dataSharing planned: 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/.
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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.
Use 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 degarelix 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 5 inclusion and 8 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 31 Oct 2024. 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?
Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time (time frame: Baseline and for one 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 31 Oct 2024.