Trial · NCT06984159
The Study Will Evaluate if Leuprolide Mesylate is Safe and Effective in the Treatment of Subjects With Advanced Prostate Carcinoma, When Administered as Two Injections Six Months Apart.
NCT06984159, Phase 3, Completed, Changchun GeneScience Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Study Will Evaluate if Leuprolide Mesylate is Safe and Effective in the Treatment of Subjects With Advanced Prostate Carcinoma, When Administered as Two Injections Six Months Apart. Trials, record NCT06984159. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06984159
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Study Will Evaluate if Leuprolide Mesylate is Safe and Effective in the Treatment of Subjects With Advanced Prostate Carcinoma, When Administered as Two Injections Six Months Apart.
- NCT number
- NCT06984159
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 137 participants, actual
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Conditions
- Advanced Prostate Cancer
- Interventions
- Leuprolide Injectable Emulsion (CAMCEVI®)
- First posted
- 2025-05-22
- Last updated
- 2025-05-22
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative probability of maintaining serum testosterone at a castrate level (≤ 50 ng/dL) from the end of 28 days after the first dose to the end of 168 days after the second dose. | from the end of 28 days after the first dose to the end of 168 days after the second dose. | To evaluate the castrate level maintenance of Leuprolide Injectable Emulsion from the end of 28 days after the first dose to the end of 168 days after the second dose, with serum testosterone as a surrogate parameter for the assessment of efficacy and a castrate level of 50 ng/dL. |
| Primary | including but not limited to:adverse events (AEs) and serious adverse events (SAEs), vital signs, physical examination, laboratory tests, 12-lead electrocardiogram (ECG), injection site reactions, local tolerance, etc. | 336 days | To evaluate the safety and tolerability of Leuprolide Injectable Emulsion after two subcutaneous injections in patients with advanced prostate cancer. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06984159
GET https://conductscience.org/api/trials/v1/NCT06984159/registered