Prostate CancersNCT06929884
Effectiveness, Safety, and Economic Evaluation of Goserelin Microspheres for Injection and Goserelin Sustained-Release Implants in Prostate Cancer Patients: A Real-World Study
An observational study of Prostate Cancers, run by Qianfoshan Hospital at 1 site in China.
Trial summary
Prostate cancer (PC) is the most common malignancy in the male genitourinary system. In China, both the incidence and mortality rates of PC have shown a significant upward trend in recent years. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancers
- Type of treatment
- Injection or infusion
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2020to 1 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Hospitalized male patients diagnosed with PC between 2020 and 2025 at Shandong First Medical University Affiliated Hospital (Qianfoshan Hospital).
Who may be able to join
- 1. Patients with histologically confirmed prostate cancer (PC) deemed suitable for endocrine therapy (excluding neoadjuvant endocrine therapy).
- 2. At least 18 years old 3. Prescribed 3.6 mg goserelin every 4 weeks as monotherapy or in combination with anti-androgen therapy.
Who cannot join
- 1. Hypersensitivity to LHRH, its analogs, or any component of goserelin. 2. Previous or concurrent hormone therapy, except for conventional anti-androgen therapy administered within 2 weeks before goserelin treatment.
- 3. Diagnosis or suspicion of hormone-resistant PC, history of hypophysectomy, adrenalectomy, or pituitary lesions.
- 4.Scheduled for radical radiotherapy (adjuvant radiotherapy post-radical prostatectomy [RP] combined with goserelin is permitted) or planned neoadjuvant hormone therapy prior to RP.
Trial locations and contacts
1 site in 1 country.
About this study
Prostate cancer (PC) is the most common malignancy in the male genitourinary system. In China, both the incidence and mortality rates of PC have shown a significant upward trend in recent years. Chinese patients are typically diagnosed at older ages with higher preoperative prostate-specific antigen (PSA) levels compared to Western populations, indicating a more aggressive disease phenotype. This may explain the lower 5-year survival rates in Chinese PC patients. Over the past three decades, the age-standardized incidence of PC in China has surged by 95.2%, while the global rate increased by only 13.2%. Conversely, global PC mortality decreased by 15.7%, whereas China saw a mere 5.3% reduction. The high economic burden on patients and healthcare systems underscores the urgency of optimizing treatment strategies. Direct annual medical costs for PC in China average $3,500 per patient, with drug expenses accounting for over 60% and out-of-pocket payments comprising approximately 20%. These costs far exceed those of other malignancies, posing sustainability challenges for families and insurance systems. Androgen deprivation therapy (ADT), including surgical or chemical castration, remains the cornerstone for advanced PC. Chemical castration via luteinizing hormone-releasing hormone (LHRH) agonists or antagonists offers comparable survival benefits to surgical castration but with improved quality of life. Goserelin, a synthetic GnRH analog, has been widely used since 1987. Current formulations include a sustained-release implant (10.8 mg/3.6 mg) administered subcutaneously every 28 days using a 16G needle (outer diameter: 1.6 mm), which may cause injection-site injuries, and a newer microsphere formulation (3.6 mg) delivered intramuscularly via a 21G needle (outer diameter: 0.8 mm), enhancing patient tolerance. While Phase III trials showed no significant efficacy differences between the two formulations, real-world evidence is lacking. This retrospective cohort study aims to evaluate the effectiveness, safety, and cost-effectiveness of both formulations using real-world data.
- Conditions
- Prostate Cancers
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients receiving 3.6 mg goserelin sustained-release implants (subcutaneous). | |
| Intervention: | Patients receiving 3.6 mg goserelin microspheres (intramuscular). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum testosterone
Serum testosterone
Measured: baseline, 1, 6, 12, and >12 months
PSA levels
Measured: baseline, 1, 6, 12, and >12 months
percentage of patients achieving testosterone suppression (≤50 ng/dL and ≤20 ng/dL)
Measured: baseline, 1, 6, 12, and >12 months
digital rectal examination (DRE)
Measured: baseline, 1, 6, 12, and >12 months
Secondary outcomes (1)
Imaging results (bone scans, pelvic/abdominal imaging), treatment adherence, adverse events (injection-site reactions), metabolic changes, hepatic/renal dysfunction), and cost-effectiveness analysis (CEA).
Measured: >12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start2 Apr 2020
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancersStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui Yang, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929884
- Sponsor's protocol ID
- LCYX-YR-20230103
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness, Safety, and Economic Evaluation of Goserelin Microspheres for Injection and Goserelin Sustained-Release Implants in Prostate Cancer Patients: A Real-World Study
- ClinicalTrials.gov ID
- NCT06929884
- Acronym / sponsor ID
- LCYX-YR-20230103
- Conditions
- Prostate Cancers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 16 Apr 2025 (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.
Prostate cancer (PC) is the most common malignancy in the male genitourinary system. In China, both the incidence and mortality rates of PC have shown a significant upward trend in recent years. Chinese patients are typically diagnosed at older ages with higher preoperative prostate-specific antigen (PSA) levels compared to Western populations, indicating a more aggressive disease phenotype. This may explain the lower 5-year survival rates in Chinese PC patients. Over the past three decades, the age-standardized incidence of PC in China has surged by 95.2%, while the global rate increased by only 13.2%. Conversely, global PC mortality decreased by 15.7%, whereas China saw a mere 5.3% reduction. The high economic burden on patients and healthcare systems underscores the urgency of optimizing treatment strategies. Direct annual medical costs for PC in China average $3,500 per patient, with drug expenses accounting for over 60% and out-of-pocket payments comprising approximately 20%. These costs far exceed those of other malignancies, posing sustainability challenges for families and insurance systems. Androgen deprivation therapy (ADT), including surgical or chemical castration, remains the cornerstone for advanced PC. Chemical castration via luteinizing hormone-releasing hormone (LHRH) agonists or antagonists offers comparable survival benefits to surgical castration but with improved quality of life. Goserelin, a synthetic GnRH analog, has been widely used since 1987. Current formulations include a sustained-release implant (10.8 mg/3.6 mg) administered subcutaneously every 28 days using a 16G needle (outer diameter: 1.6 mm), which may cause injection-site injuries, and a newer microsphere formulation (3.6 mg) delivered intramuscularly via a 21G needle (outer diameter: 0.8 mm), enhancing patient tolerance. While Phase III trials showed no significant efficacy differences between the two formulations, real-world evidence is lacking. This retrospective cohort study aims to evaluate the effectiveness, safety, and cost-effectiveness of both formulations using real-world data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Patients receiving 3.6 mg goserelin sustained-release implants (subcutaneous). |
| Intervention: | – | –Patients receiving 3.6 mg goserelin microspheres (intramuscular). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized male patients diagnosed with PC between 2020 and 2025 at Shandong First Medical University Affiliated Hospital (Qianfoshan Hospital).
Key inclusion criteria (2 listed)
- 1. Patients with histologically confirmed prostate cancer (PC) deemed suitable for endocrine therapy (excluding neoadjuvant endocrine therapy).
- 2. At least 18 years old 3. Prescribed 3.6 mg goserelin every 4 weeks as monotherapy or in combination with anti-androgen therapy.
Key exclusion criteria (3 listed)
- 1. Hypersensitivity to LHRH, its analogs, or any component of goserelin. 2. Previous or concurrent hormone therapy, except for conventional anti-androgen therapy administered within 2 weeks before goserelin treatment.
- 3. Diagnosis or suspicion of hormone-resistant PC, history of hypophysectomy, adrenalectomy, or pituitary lesions.
- 4.Scheduled for radical radiotherapy (adjuvant radiotherapy post-radical prostatectomy [RP] combined with goserelin is permitted) or planned neoadjuvant hormone therapy prior to RP.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum testosterone
Time frame: baseline, 1, 6, 12, and >12 months
Serum testosterone
PSA levels
Time frame: baseline, 1, 6, 12, and >12 months
percentage of patients achieving testosterone suppression (≤50 ng/dL and ≤20 ng/dL)
Time frame: baseline, 1, 6, 12, and >12 months
digital rectal examination (DRE)
Time frame: baseline, 1, 6, 12, and >12 months
1 secondary outcome
Imaging results (bone scans, pelvic/abdominal imaging), treatment adherence, adverse events (injection-site reactions), metabolic changes, hepatic/renal dysfunction), and cost-effectiveness analysis (CEA).
Time frame: >12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancers, run by Qianfoshan Hospital 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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Serum testosterone (time frame: baseline, 1, 6, 12, and >12 months). The study lists 4 primary outcomes in all. 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 16 Apr 2025.