Prostate CancerPhase 2NCT06385847
To Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer
A Phase 2 study testing Zoladex and LY01005 in people with Prostate Cancer, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
The GOMIMP will be a Prospective, Randomized, Cross-over Trial to Explore the Patient Preference for Goserelin Microsphere (Zoladex®) Versus Goserelin Implant (LY01005) in Patients of Prostate Cancer Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Zoladex and LY01005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- May 2024to Dec 2025
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients older than 18 years
- Histologically confirmed prostate adenocarcinoma
- Suitable for ADT treatment
- ECOG≤2
- Prior treatment without GnRH agonists
- Expected survival >1 year
Show all 14Show fewer
- Good compliance
- Adequate organ or bone marrow function as evidenced by:
- Hemoglobin >/= 10 g/dL
- Absolute neutrophil count >/=1.5 x 109/L,
- Platelet count >/=100 x 109/L,
- AST/SGOT and/or ALT/SGPT </=1.5 x ULN;
- Total bilirubin </=1.5 x ULN,
- Serum creatinine </=1.5 x ULN. If creatinine 1.0 - 1.5 xULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded
Who cannot join
- Prior treatment with Zoladex, LY01005 or other GnRH agonists, while GnRH agonists for < 6 months and discontinued for more than 6 months were allowed
- Diagnosed or suspected hormone-resistant prostate cancer, hypophysectomy, adrenalectomy, or pituitary lesions
- A history of cardiovascular events, uncontrolled hypertension, gastrointestinal disease that interferes with treatment absorption, active viral hepatitis, or human immunodeficiency infection (HIV) within the past 6 months
- Any medical conditions that the investigators believe make the patient ineligible to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Xuegang Wang, doctor, 15960263909, stefwxg@163.com
About this study
Official title: Cross-Over Trial to Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer
The GOMIMP will be a Prospective, Randomized, Cross-over Trial to Explore the Patient Preference for Goserelin Microsphere (Zoladex®) Versus Goserelin Implant (LY01005) in Patients of Prostate Cancer
Read the detailed description
Androgen Deprivation Therapy (ADT) is an important systemic therapy for prostate cancer, which plays a vital role in the treatment of various stages of prostate cancer. Gonadotropin-releasing hormone (GnRH) agonists are the most commonly used ADT treatment，including leuprolide, goserelin, and triptorelin. The goserelin implant (Zoladex®) 3.6 mg is administered subcutaneously every 28 days into the anterior abdominal wall using a pre-filled syringe with a 16G needle (outer diameter 1.6 mm), while the Goserelin microsphere (LY01005) 3.6 mg is administered every 28 days by intramuscular injection using a 21G injection needle (outer diameter 0.8 mm). Phase III study (NCT04563936) have confirmed the similar efficacy and safety between the two drugs, but patient preference for both are unknown.
The objective of this study was to explore the patient preference for goserelin microsphere versus goserelin implant in patients of prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Zoladex, LY01005
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZoladexDrug
Patients received 3.6 mg subcutaneous Zoladex
LY01005Drug
Patients received 3.6 mg intramuscular LY01005
| Study group | Role | What they receive |
|---|---|---|
| Zo-LY | Other | Arm Zo-LY: Zoladex 3.6 mg (s.c.)/4W ✖ 2 cycles, followed by LY01005 3.6 mg (i.m.)/4W ✖ 2 cycles Receives: Drug: Zoladex; Drug: LY01005 |
| LY-Zo | Other | Arm LY-Zo: LY01005 3.6 mg (i.m.)/4W ✖ 2 cycles, followed by Zoladex 3.6 mg (s.c.)/4W ✖ 2 cycles Receives: Drug: Zoladex; Drug: LY01005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient preference
Patient preference (assessed by a single question) between Zoladex and LY01005 after completion of the second period of treatment.
Measured: Assessed up 16 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, randomized, open-label, cross-over phase II trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Xuegang, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385847
- Sponsor's protocol ID
- GOMIMP
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Over Trial to Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT06385847
- Acronym / sponsor ID
- GOMIMP
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Apr 2024 (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.
The GOMIMP will be a Prospective, Randomized, Cross-over Trial to Explore the Patient Preference for Goserelin Microsphere (Zoladex®) Versus Goserelin Implant (LY01005) in Patients of Prostate Cancer
Detailed description
Androgen Deprivation Therapy (ADT) is an important systemic therapy for prostate cancer, which plays a vital role in the treatment of various stages of prostate cancer. Gonadotropin-releasing hormone (GnRH) agonists are the most commonly used ADT treatment，including leuprolide, goserelin, and triptorelin. The goserelin implant (Zoladex®) 3.6 mg is administered subcutaneously every 28 days into the anterior abdominal wall using a pre-filled syringe with a 16G needle (outer diameter 1.6 mm), while the Goserelin microsphere (LY01005) 3.6 mg is administered every 28 days by intramuscular injection using a 21G injection needle (outer diameter 0.8 mm). Phase III study (NCT04563936) have confirmed the similar efficacy and safety between the two drugs, but patient preference for both are unknown.
The objective of this study was to explore the patient preference for goserelin microsphere versus goserelin implant in patients of prostate cancer.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, open-label, cross-over phase II trial
| Arm | Type | Receives |
|---|---|---|
| Zo-LY | Other | Drug: Zoladex, Drug: LY01005Arm Zo-LY: Zoladex 3.6 mg (s.c.)/4W ✖ 2 cycles, followed by LY01005 3.6 mg (i.m.)/4W ✖ 2 cycles |
| LY-Zo | Other | Drug: Zoladex, Drug: LY01005Arm LY-Zo: LY01005 3.6 mg (i.m.)/4W ✖ 2 cycles, followed by Zoladex 3.6 mg (s.c.)/4W ✖ 2 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male patients older than 18 years
- Histologically confirmed prostate adenocarcinoma
- Suitable for ADT treatment
- ECOG≤2
- Prior treatment without GnRH agonists
Key exclusion criteria (4 listed)
- Prior treatment with Zoladex, LY01005 or other GnRH agonists, while GnRH agonists for < 6 months and discontinued for more than 6 months were allowed
- Diagnosed or suspected hormone-resistant prostate cancer, hypophysectomy, adrenalectomy, or pituitary lesions
- A history of cardiovascular events, uncontrolled hypertension, gastrointestinal disease that interferes with treatment absorption, active viral hepatitis, or human immunodeficiency infection (HIV) within the past 6 months
- Any medical conditions that the investigators believe make the patient ineligible to participate in the study
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 |
|---|---|---|
| ZoladexPatients received 3.6 mg subcutaneous Zoladex | Drug | LY-Zo, Zo-LY |
| LY01005Patients received 3.6 mg intramuscular LY01005 | Drug | LY-Zo, Zo-LY |
Primary outcome
Patient preference
Time frame: Assessed up 16 weeks after randomization
Patient preference (assessed by a single question) between Zoladex and LY01005 after completion of the second period of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zoladex and LY01005 in people with Prostate Cancer, run by The First Affiliated Hospital of Xiamen University 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 14 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: status not confirmed, as of the sponsor's last update on 26 Apr 2024. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuegang Wang, doctor (15960263909, stefwxg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient preference (time frame: Assessed up 16 weeks after randomization). 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 26 Apr 2024.