Prostate CancerPhase 3NCT01964170
A Study to Compare the Effect of ASP3550 With Goserelin in Patients With Prostate Cancer
A Phase 3 study testing degarelix and Goserelin in people with Prostate Cancer, run by Astellas Pharma Inc at 8 sites in Japan.
Trial summary
To compare the efficacy and safety of ASP3550 to goserelin acetate 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
- Prostate Cancer
- What is being tested?
- degarelix and Goserelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 8 sitesJapan
- Study dates
- 13 Aug 2013to 8 Aug 2016
- Phase
- Phase 3
- 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
- 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.
Who cannot join
- 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.
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
Kyushu
Study site
Shikoku
Study site
Tōhoku
About this study
Official title: ASP3550 Phase III Study - An Open-Label, Active-Controlled, Parallel-Arm Study, Comparing ASP3550 With Goserelin Acetate in Patients With Prostate Cancer -
To compare the efficacy and safety of ASP3550 to goserelin acetate in patients with prostate cancer.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- degarelix, Goserelin
- Keywords
- 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
subcutaneous
GoserelinDrug
subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| ASP3550 PART 1 and PART 2 | Experimental | Part 1 for 1 year treatment and Part 2 for an extended period of treatment Receives: Drug: degarelix |
| Goserelin | Active comparator | part 1 for 1 year treatment Receives: Drug: Goserelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative castration rate of treatment in terms of serum testosterone level
Measured: Up to one year of the treatment
Secondary outcomes (4)
Proportion of castrated subjects in terms of serum testosterone level
Measured: Up to one year of the treatment
Proportion of castrated subjects in terms of serum testosterone level
Measured: Baseline and Days 3, 7, and 28
Changes in serum levels of prostate-specific antigen (PSA) over time
Measured: Up to one year of the treatment
Safety assessed by the incidence of adverse events
Measured: up to the end of treatment. approximately for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study start13 Aug 2013
- Primary completion5 Jun 2015
- Study completion8 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Principal investigator, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964170
- Sponsor's protocol ID
- 3550-CL-0010
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2013
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- 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/.
Publications
Zengerling 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.
PubMed 34350976Ozono S, Tsukamoto T, Naito S, Horie S, Ohashi Y, Uemura H, Yokomizo Y, Fukasawa S, Kusuoka H, Akazawa R, Saito M, Akaza H. Efficacy and safety of 3-month dosing regimen of degarelix in Japanese subjects with prostate cancer: A phase III study. Cancer Sci. 2018 Jun;109(6):1920-1929. doi: 10.1111/cas.13600. Epub 2018 May 23.
PubMed 29624800
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 III Study - An Open-Label, Active-Controlled, Parallel-Arm Study, Comparing ASP3550 With Goserelin Acetate in Patients With Prostate Cancer -
- ClinicalTrials.gov ID
- NCT01964170
- Acronym / sponsor ID
- 3550-CL-0010
- Conditions
- Prostate Cancer
- Keywords
- ASP3550, Prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2013 (actual)
- Primary completion
- 5 Jun 2015 (actual)
- Study completion
- 8 Aug 2016 (actual)
- First posted
- 17 Oct 2013 (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 compare the efficacy and safety of ASP3550 to goserelin acetate in patients with prostate cancer.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASP3550 PART 1 and PART 2 | Experimental | Drug: degarelixPart 1 for 1 year treatment and Part 2 for an extended period of treatment |
| Goserelin | Active comparator | Drug: Goserelinpart 1 for 1 year treatment |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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: ASP3550subcutaneous | Drug | ASP3550 PART 1 and PART 2 |
| Goserelinsubcutaneous | Drug | Goserelin |
Primary outcome
Cumulative castration rate of treatment in terms of serum testosterone level
Time frame: Up to one year of the treatment
4 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
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.
- Derived from this study: PubMed 34350976Zengerling 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.
- Derived from this study: PubMed 29624800Ozono S, Tsukamoto T, Naito S, Horie S, Ohashi Y, Uemura H, Yokomizo Y, Fukasawa S, Kusuoka H, Akazawa R, Saito M, Akaza H. Efficacy and safety of 3-month dosing regimen of degarelix in Japanese subjects with prostate cancer: A phase III study. Cancer Sci. 2018 Jun;109(6):1920-1929. doi: 10.1111/cas.13600. Epub 2018 May 23.
- 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.
Medical Director principal investigator
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 3 study testing degarelix and Goserelin in people with Prostate Cancer, 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 6 inclusion and 7 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Cumulative castration rate of treatment in terms of serum testosterone level (time frame: Up to one year of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01964170, which also lists 2 linked publications.
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.