Prostate CancerPhase 3NCT04563936
Efficacy and Safety of LY01005 in Patients With Prostate Cancer Compared to ZOLADEX®
A Phase 3 study testing LY01005 3.6 mg and ZOLADEX® 3.6 mg in people with Prostate Cancer, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, open-label, active comparator-controlled phase Ⅲ trial to compare efficacy and safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01005) and ZOLADEX® in patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- LY01005 3.6 mg and ZOLADEX® 3.6 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2020to 9 Mar 2021
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 years or older.
- Patients with pathological confirmed prostate cancer suitable for endocrine therapy (except for neoadjuvant endocrine therapy), including those who are suitable for endocrine therapy (such as patients with biochemical recurrence after adjuvant endocrine therapy and radical therapy) following radical therapy.
- Serum testosterone level ≥ 1.50 ng/mL (5.21 nmol/L) at the screening visit (based on the test results of research centers).
- Life expectancy of at least 9 months.
- ECOG score of ≤ 2.
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L, white blood cell count ≥ 3 x 10^9/L, and hemoglobin ≥ 90 g/L at the screening visit.
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- Total bilirubin (TBIL) ≤ 1.5×ULN, both ALT and AST ≤ 2.5×ULN (or ≤ 5.0×ULN for patients with liver metastases) at the screening visit.
- Calculated creatinine clearance (Cockcroft-Gault formula) of ≥ 30 mL/min at the screening visit.
- Patients who voluntarily sign an IRB-approved informed consent form before the screening visit, are willing to abide by the restrictions of the study, and complete the prescribed examinations.
Who cannot join
- Patients with prostate cancer who receive previous or ongoing endocrine therapy (surgical castration or other endocrine therapy including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, megestrol acetate, etc.), except for patients with prostate cancer undergoing prostatectomy, radiotherapy or cryotherapy who have received neoadjuvant/adjuvant endocrine therapy for no more than 6 months and discontinued the above therapy more than 6 months before screening.
- Has received prostatic surgery within 4 weeks prior to the Screening Visit, or plan to receive surgical treatment during the trial.
- Patients with confirmed or suspected hormone-resistant prostate cancer.
- Has previously received hypophysectomy or adrenalectomy, or who have pituitary lesions.
- Has received 5-α reductase inhibitors (finasteride, dutasteride, eridasteride, etc.) within 1 month before the first dose.
- Has previously received goserelin.
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- Has received an investigational drug, an investigational biological product or an investigational medical device, and discontinued within 1 month or 5 half-lives of the corresponding drug before the screening visit, whichever is longer.
- History of severe asthma, anaphylaxis, or severe urticaria and/or angioedema.
- History or presence of another malignancy, other than surgically removed squamous/basal cell carcinoma of the skin, within the last 5 years.
- History of the following medical histories within 6 months: myocardial infarction, unstable angina, coronary revascularization, New York Heart Association (NYHA) class ≥ II cardiac insufficiency, severe unstable arrhythmia; Or the presence of arrhythmia requiring treatment at the screening period.
- Hypertensive patients with poor blood pressure control after medication (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg at the screening visit).
- Has received coumarin anticoagulants.
- Patients with type 1 diabetes or type 2 diabetes with poor glycemic control (glycosylated hemoglobin > 8% at the screening visit).
- Has congenital long QT syndrome or QT/QTc interval prolongation (QTc ≥ 450 ms) at the screening visit; Or has received drugs that may prolong QT/QTc interval at the screening visit.
- Alcoholics, drug addicts or drug abusers.
- Patients of childbearing potential who refuse using effective contraception during the entire trial.
- Patients with viral hepatitis B who are taking anti-hepatitis B virus (HBV) drugs or need drug treatment (those who need drug treatment must meet the following 2 conditions at the same time: 1. HBV DNA level: HBeAg-positive patients, HBV DNA ≥ 20,000 IU/ml [equivalent to 10^5 copies/mL]; HBeAg-negative patients, HBV DNA ≥ 2,000 IU/ml [equivalent to 10^4 copies/mL]; 2. ALT ≥ 2 x ULN).
- Patients who are seropositive for hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antibody.
- Known to be allergic to the active ingredients or any excipients of the investigational drug, or other GnRH analogues.
- Other conditions considered unsuitable for enrollment by the investigator (such as spinal cord compression due to prostate cancer metastatic lesions of pyramid, pulmonary interstitial disease or other serious diseases).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Open-Label Phase Ⅲ Trial to Compare Efficacy and Safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01005) and ZOLADEX® in Patients With Prostate Cancer
This is a multicenter, randomized, open-label, active comparator-controlled phase Ⅲ trial to compare efficacy and safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01005) and ZOLADEX® in patients with prostate cancer.
Read the detailed description
This is a multicenter, randomized, open-label, active comparator-controlled phase Ⅲ trial using non-inferior design. A total of 290 patients with prostate cancer who were suitable for endocrine therapy were enrolled into the screening period from D-21 to D-10 before administration. Eligible subjects were treated with bicalutamide tablets (Casodex®, 50 mg/day) from D-10 (± 3d) before administration and randomized in a 1:1 ratio to receive LY01005 3.6 mg or ZOLADEX® 3.6 mg after completion of pretreatment. All subjects were administered once every 28 days for three doses until intolerable toxicity, disease progression requiring other anti-tumor treatments, withdrawal of consent, loss to follow-up, death or the end of the whole study. Blood samples were collected at the specified time points of the screening period, before/behind each dose to detect serum testosterone, LH, FSH and PSA. Safety evaluation (including vital signs, physical examination, laboratory tests, 12 ECG, adverse events, etc.) was conducted as required in the protocol.
- Conditions
- Prostate Cancer
- Being tested
- LY01005 3.6 mg, ZOLADEX® 3.6 mg
- Keywords
- Prostate Cancer, LY01005, Efficacy, Safety
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY01005 3.6 mgDrug
Also called Goserelin Acetate Sustained-Release Microspheres for Injection
LY01005 was administered as 3 intramuscular (IM) injections, 28 days apart. As concomitant medications, Casodex® (50 mg/day) was orally administered during the whole study period.
ZOLADEX® 3.6 mgDrug
Also called goserelin acetate implant 3.6 mg
ZOLADEX® was administered as 3 Subcutaneous (SC) injections, 28 days apart. As concomitant medications, Casodex® (50 mg/day) was orally administered during the whole study period.
| Study group | Role | What they receive |
|---|---|---|
| LY01005 3.6 mg | Experimental | Intramuscular injections of LY01005 3.6 mg every 28 days for a maximum of 3 consecutive doses. Receives: Drug: LY01005 3.6 mg |
| ZOLADEX® 3.6 mg | Active comparator | Subcutaneous injections of ZOLADEX® 3.6 mg every 28 days for a maximum of 3 consecutive doses. Receives: Drug: ZOLADEX® 3.6 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects with serum testosterone ≤50 ng/dL (1.735 nmol/L) on Day 29 after the first dose.
Measured: Day 29 after the first dose
The cumulative percentage of subjects with the maintenance of serum testosterone ≤50 ng/dL (1.735 nmol/L) from Day 29 to Day 85.
Measured: from Day 29 to Day 85
Secondary outcomes (10)
Significant Castration Rate
The percentage of subjects with serum testosterone ≤20 ng/dL (0.7 nmol/L) on Day 29 after the first dose, and the cumulative percentage of subjects with the maintenance of serum testosterone ≤20 ng/dL (0.7 nmol/L) from Day 29 to Day 85.
Measured: from Day 29 to Day 85
The percentage of subjects with an acute increase in serum testosterone above castrate levels within 72 hours following repeated dosing.
Measured: within 72 hours following the second and third administration
Percentage changes compared to baseline in serum LH level after administration.
Measured: from baseline to Day 85
Changes in serum LH level after administration.
Measured: from baseline to Day 85
Percentage changes compared to baseline in serum FSH level after administration.
Measured: from baseline to Day 85
Changes in serum FSH level after administration.
Measured: from baseline to Day 85
Percentage changes compared to baseline in serum PSA level after administration.
Measured: from baseline to Day 85
Changes in serum PSA level after administration.
Measured: from baseline to Day 85
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: up to Day 85
Incidence of serious adverse events (SAE).
Measured: up to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start6 Jan 2020
- Primary completion9 Mar 2021
- Study completion9 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group Ltd.The sponsor's other registered studies.
- 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
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dingwei Ye, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563936
- Sponsor's protocol ID
- LY01005/CT-CHN-302
- Status last verified
- Aug 2021
- First submitted
- 21 Sep 2020
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gu C, Wang Z, Lin T, Liu Z, Han W, Zhang X, Liang C, Liu H, Yu Y, Xu Z, Liu S, Wang J, Jia L, Yao X, Liao W, Fu C, Tan Z, He G, Zhu G, Fan R, Yang W, Chen X, Liu Z, Zhong L, Shi B, Ding D, Chen S, Wei J, Yao X, Chen M, Lu Z, Xie Q, Hu Z, Wang Y, Guo H, Fan T, Liang Z, Chen P, Wang W, Xu T, Li C, Xing J, Liao H, He D, Wu Z, Yu J, Feng Z, Yang M, Dou Q, Zeng Q, Li Y, Gou X, Zhou G, Wang X, Zhu R, Zhang Z, Zhang B, Tan W, Qu X, Sun H, Gan T, Ye D. Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial. Chin Med J (Engl). 2023 May 20;136(10):1207-1215. doi: 10.1097/CM9.0000000000002638. Epub 2023 Apr 3.
PubMed 37010251
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label Phase Ⅲ Trial to Compare Efficacy and Safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01005) and ZOLADEX® in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT04563936
- Acronym / sponsor ID
- LY01005/CT-CHN-302
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, LY01005, Efficacy, Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 9 Mar 2021 (actual)
- First posted
- 25 Sep 2020 (actual)
- 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.
This is a multicenter, randomized, open-label, active comparator-controlled phase Ⅲ trial to compare efficacy and safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01005) and ZOLADEX® in patients with prostate cancer.
Detailed description
This is a multicenter, randomized, open-label, active comparator-controlled phase Ⅲ trial using non-inferior design. A total of 290 patients with prostate cancer who were suitable for endocrine therapy were enrolled into the screening period from D-21 to D-10 before administration. Eligible subjects were treated with bicalutamide tablets (Casodex®, 50 mg/day) from D-10 (± 3d) before administration and randomized in a 1:1 ratio to receive LY01005 3.6 mg or ZOLADEX® 3.6 mg after completion of pretreatment. All subjects were administered once every 28 days for three doses until intolerable toxicity, disease progression requiring other anti-tumor treatments, withdrawal of consent, loss to follow-up, death or the end of the whole study. Blood samples were collected at the specified time points of the screening period, before/behind each dose to detect serum testosterone, LH, FSH and PSA. Safety evaluation (including vital signs, physical examination, laboratory tests, 12 ECG, adverse events, etc.) was conducted as required in the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY01005 3.6 mg | Experimental | Drug: LY01005 3.6 mgIntramuscular injections of LY01005 3.6 mg every 28 days for a maximum of 3 consecutive doses. |
| ZOLADEX® 3.6 mg | Active comparator | Drug: ZOLADEX® 3.6 mgSubcutaneous injections of ZOLADEX® 3.6 mg every 28 days for a maximum of 3 consecutive doses. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 50 years or older.
- Patients with pathological confirmed prostate cancer suitable for endocrine therapy (except for neoadjuvant endocrine therapy), including those who are suitable for endocrine therapy (such as patients with biochemical recurrence after adjuvant endocrine therapy and radical therapy) following radical therapy.
- Serum testosterone level ≥ 1.50 ng/mL (5.21 nmol/L) at the screening visit (based on the test results of research centers).
- Life expectancy of at least 9 months.
- ECOG score of ≤ 2.
Key exclusion criteria (20 listed)
- Patients with prostate cancer who receive previous or ongoing endocrine therapy (surgical castration or other endocrine therapy including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, megestrol acetate, etc.), except for patients with prostate cancer undergoing prostatectomy, radiotherapy or cryotherapy who have received neoadjuvant/adjuvant endocrine therapy for no more than 6 months and discontinued the above therapy more than 6 months before screening.
- Has received prostatic surgery within 4 weeks prior to the Screening Visit, or plan to receive surgical treatment during the trial.
- Patients with confirmed or suspected hormone-resistant prostate cancer.
- Has previously received hypophysectomy or adrenalectomy, or who have pituitary lesions.
- Has received 5-α reductase inhibitors (finasteride, dutasteride, eridasteride, etc.) within 1 month before the first dose.
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 |
|---|---|---|
| LY01005 3.6 mgAlso: Goserelin Acetate Sustained-Release Microspheres for InjectionLY01005 was administered as 3 intramuscular (IM) injections, 28 days apart. As concomitant medications, Casodex® (50 mg/day) was orally administered during the whole study period. | Drug | LY01005 3.6 mg |
| ZOLADEX® 3.6 mgAlso: goserelin acetate implant 3.6 mgZOLADEX® was administered as 3 Subcutaneous (SC) injections, 28 days apart. As concomitant medications, Casodex® (50 mg/day) was orally administered during the whole study period. | Drug | ZOLADEX® 3.6 mg |
Primary outcome
The percentage of subjects with serum testosterone ≤50 ng/dL (1.735 nmol/L) on Day 29 after the first dose.
Time frame: Day 29 after the first dose
The cumulative percentage of subjects with the maintenance of serum testosterone ≤50 ng/dL (1.735 nmol/L) from Day 29 to Day 85.
Time frame: from Day 29 to Day 85
10 secondary outcomes
Significant Castration Rate
Time frame: from Day 29 to Day 85
The percentage of subjects with an acute increase in serum testosterone above castrate levels within 72 hours following repeated dosing.
Time frame: within 72 hours following the second and third administration
Percentage changes compared to baseline in serum LH level after administration.
Time frame: from baseline to Day 85
Changes in serum LH level after administration.
Time frame: from baseline to Day 85
Percentage changes compared to baseline in serum FSH level after administration.
Time frame: from baseline to Day 85
Changes in serum FSH level after administration.
Time frame: from baseline to Day 85
Percentage changes compared to baseline in serum PSA level after administration.
Time frame: from baseline to Day 85
Changes in serum PSA level after administration.
Time frame: from baseline to Day 85
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: up to Day 85
Incidence of serious adverse events (SAE).
Time frame: up to Day 85
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 26 Aug 2021.
- Derived from this study: PubMed 37010251Gu C, Wang Z, Lin T, Liu Z, Han W, Zhang X, Liang C, Liu H, Yu Y, Xu Z, Liu S, Wang J, Jia L, Yao X, Liao W, Fu C, Tan Z, He G, Zhu G, Fan R, Yang W, Chen X, Liu Z, Zhong L, Shi B, Ding D, Chen S, Wei J, Yao X, Chen M, Lu Z, Xie Q, Hu Z, Wang Y, Guo H, Fan T, Liang Z, Chen P, Wang W, Xu T, Li C, Xing J, Liao H, He D, Wu Z, Yu J, Feng Z, Yang M, Dou Q, Zeng Q, Li Y, Gou X, Zhou G, Wang X, Zhu R, Zhang Z, Zhang B, Tan W, Qu X, Sun H, Gan T, Ye D. Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial. Chin Med J (Engl). 2023 May 20;136(10):1207-1215. doi: 10.1097/CM9.0000000000002638. Epub 2023 Apr 3.
- Individual participant dataSharing planned: No
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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.
Dingwei Ye principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LY01005 3.6 mg and ZOLADEX® 3.6 mg in people with Prostate Cancer, run by Luye Pharma Group Ltd. at 1 site in China.
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 9 inclusion and 20 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 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The percentage of subjects with serum testosterone ≤50 ng/dL (1.735 nmol/L) on Day 29 after the first dose. (time frame: Day 29 after the first dose). The study lists 2 primary outcomes in all. 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 NCT04563936, which also lists 1 linked publication.
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 26 Aug 2021.