Prostatic NeoplasmsPhase 3NCT03261999
Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer
A Phase 3 study testing Leuprolide Mesylate in people with Prostatic Neoplasms, run by Foresee Pharmaceuticals Co., Ltd. at 21 sites in 5 countries.
Trial summary
The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with prostate cancer, when administered as two injections twelve weeks apart. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Leuprolide Mesylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 21 sitesin 5 countries
- Study dates
- 26 Sep 2017to 1 Feb 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Males aged ≥ 18 years old
- Males with histologically confirmed carcinoma of the prostate
- Subjects who are judged by the attending physician and/or Principal Investigator to be a candidate for androgen ablation therapy
- Baseline morning serum testosterone level > 150 ng/dL performed at Screening Visit
- Eastern Cooperative Oncology Group (ECOG) Performance score ≤ 2
- Life expectancy of at least 18 months
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- Laboratory values
- Absolute neutrophil count ≥ 1,500 cells/µL
- Platelets ≥ 100,000 cells/µL
- Hemoglobin ≥ 10 gm/dL
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- AST (SGOT) ≤ 2.5 × ULN
- ALT (SGPT) ≤ 2.5 × ULN
- Serum creatinine ≤ 1.5 mg/dL
- Lipid profile within acceptable range according to investigator's opinion
- Serum glucose within acceptable range according to investigator's opinion
- HgbA1c within acceptable range according to investigator's opinion
- Clinical chemistries (K, Na, Mg, Ca and P) within acceptable range according to investigator's judgment
- Serum glucose within acceptable range according to investigator's judgement
- Urinalysis within normal range according to the investigator's judgment
- Agree to use male contraceptive methods during study trial
- Based on the Investigator's judgment, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol
- All aspects of the protocol explained and written informed consent obtained
Who cannot join
- Receipt of chemotherapy, immunotherapy, cryotherapy, radiotherapy, or anti- androgen therapy concomitantly, or within 8 weeks prior to Screening Visit, for treatment of carcinoma of the prostate. Radiation for pain control will be allowed during the study.
- Receipt of any vaccination (including influenza) within 4 weeks of screening visit
- History of blood donation within 2 months of screening visit
- History of anaphylaxis to any LH-RH analogues
- Receipt of any LHRH suppressive therapy within 6 months of screening visit
- Major surgery, including any prostatic surgery, within 4 weeks of screening visit
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- History and concomitant clinical and radiographic evidence of central nervous system/spinal cord metastases and subjects at risk for spinal cord compression
- Clinical evidence of active urinary tract obstruction and subjects at risk for urinary obstruction
- History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
- History or presence of hypogonadism, or receipt of exogenous testosterone supplementation within 6 months of Baseline
- Clinically significant abnormal ECG and/or history of clinically significant cardiovascular disease as judged by the investigator
- History of drug and/or alcohol abuse within 6 months of Baseline
- Contraindication to leuprolide or an LHRH agonist as indicated on package labeling
- Use of 5-alpha reductase inhibitor within the last 6 months of screening visit
- History or presence of insulin-dependent diabetes mellitus (Type I). Presence of well controlled diabetes mellitus Type II will be allowed if only oral hypoglycemic are required. Prostate cancer subjects with poor controlled diabetes mellitus with Hb1Ac > 9.5% or urine glycosuria > 1.0 g/dL should be excluded.
- Use of systemic corticosteroids at a dose >10 mg/d or anti-androgens
- Use of any investigational agent within 4 weeks of screening visit
- Use of any over-the-counter (OTC) medication within 4 weeks of screening visit except for those listed in the permitted Concomitant Treatment section.
- Uncontrolled intercurrent illness that would jeopardize the subject's safety, interfere with the objectives of the protocol, or limit the subject's compliance with study requirements, as determined by the Investigator in consultation with the Sponsor
Trial locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
United States6 sites
Carolina Clinical Trials, LLC
Concord, North Carolina, 28025
The Urology Center of Colorado
Denver, Colorado, 80211
Urology Centers of Alabama
Homewood, Alabama, 35209
Urology San Antonio, P.A
San Antonio, Texas, 78229
Arizona Institute of Urology
Tucson, Arizona, 85704
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462
South Korea6 sites
Pusan National University Hospital
Busan, 49241
Keimyung University Dongsan Medical Center
Daegu, 41931
National Cancer Center
Gyeonggi-do, 10408
Seoul National University Bundang Hosptal
Gyeonggi-do, 13620
Hallym University Sacred Heart Hospital
Gyeonggi-do, 14068
Korea University Anam Hospital
Seoul, 02841
Lithuania4 sites
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, 50009
Klaipėda University Hospital
Klaipėda, 92288
National Cancer Institute
Vilnius, 08660
Vilnius University Hospital, Santaros klinikos
Vilnius, 08661
Czechia3 sites
Fakultní nemocnice Hradec Králové, Urologická klinika
Hradec Králové, 500 05
Uromedical Center Olomouc
Olomouc, 779 00
Thomayerova nemocnice, Urologické oddělení
Prague, 140 59
Slovakia2 sites
UROCENTRUM MILAB, s.r.o.
Prešov, 080 01
Fakultná nemocnica s poliklinikou Žilina Urológia
Žilina, 012 07
About this study
Official title: An Open-Label, Single-Arm Study of The Efficacy, Safety, and Pharmacokinetic Behavior of Leuprolide Mesylate Injectable Suspension (LMIS 25 mg) in Subjects With Prostate Cancer
The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with prostate cancer, when administered as two injections twelve weeks apart.
Read the detailed description
This is a multi-national, multi-center, open-label, single-arm study. All subjects will be males with prostate cancer judged to be candidates for medical androgen ablation therapy and all will receive two injections of LMIS 25 mg twelve-week apart in an unblinded fashion.
- Conditions
- Prostatic Neoplasms
- Being tested
- Leuprolide Mesylate
- Keywords
- Prostate Neoplasm Cancer Carcinoma
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leuprolide MesylateDrug
Subcutaneous injection of 25mg Leuprolide Mesylate
| Study group | Role | What they receive |
|---|---|---|
| Leuprolide Mesylate 25mg | Experimental | All subjects will be males with prostate cancer. They will be injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate.
The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects will be followed until day 168. Receives: Drug: Leuprolide Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Leuprolide Mesylate (LMIS 25mg)
The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) from Day 28 through Day 168.
Measured: 168 days
Secondary outcomes (1)
Number of Participants With Adverse Events
Determining the safety and tolerability of LMIS 25 mg based on adverse events (AEs).
Measured: 168 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start26 Sep 2017
- Primary completion19 Nov 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostatic NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foresee Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Mao, PhD, Study director, Foresee Pharmaceuticals Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261999
- Sponsor's protocol ID
- FP01C-17-001
- Other IDs
- 2017-001333-88, 2017
- Status last verified
- Feb 2019
- First submitted
- 19 Aug 2017
- Last updated
- 4 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm Study of The Efficacy, Safety, and Pharmacokinetic Behavior of Leuprolide Mesylate Injectable Suspension (LMIS 25 mg) in Subjects With Prostate Cancer
- ClinicalTrials.gov ID
- NCT03261999
- Acronym / sponsor ID
- FP01C-17-001
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostate Neoplasm Cancer Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Foresee Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 19 Nov 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Posted 4 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with prostate cancer, when administered as two injections twelve weeks apart.
Detailed description
This is a multi-national, multi-center, open-label, single-arm study. All subjects will be males with prostate cancer judged to be candidates for medical androgen ablation therapy and all will receive two injections of LMIS 25 mg twelve-week apart in an unblinded fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leuprolide Mesylate 25mg | Experimental | Drug: Leuprolide MesylateAll subjects will be males with prostate cancer. They will be injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate. The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects will be followed until day 168. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Males aged ≥ 18 years old
- Males with histologically confirmed carcinoma of the prostate
- Subjects who are judged by the attending physician and/or Principal Investigator to be a candidate for androgen ablation therapy
- Baseline morning serum testosterone level > 150 ng/dL performed at Screening Visit
- Eastern Cooperative Oncology Group (ECOG) Performance score ≤ 2
Key exclusion criteria (19 listed)
- Receipt of chemotherapy, immunotherapy, cryotherapy, radiotherapy, or anti- androgen therapy concomitantly, or within 8 weeks prior to Screening Visit, for treatment of carcinoma of the prostate. Radiation for pain control will be allowed during the study.
- Receipt of any vaccination (including influenza) within 4 weeks of screening visit
- History of blood donation within 2 months of screening visit
- History of anaphylaxis to any LH-RH analogues
- Receipt of any LHRH suppressive therapy within 6 months of screening visit
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 |
|---|---|---|
| Leuprolide MesylateSubcutaneous injection of 25mg Leuprolide Mesylate | Drug | Leuprolide Mesylate 25mg |
Primary outcome
Efficacy of Leuprolide Mesylate (LMIS 25mg)
Time frame: 168 days
The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) from Day 28 through Day 168.
1 secondary outcome
Number of Participants With Adverse Events
Time frame: 168 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John Mao, PhD study director
Foresee Pharmaceuticals Co., Ltd.
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Leuprolide Mesylate in people with Prostatic Neoplasms, run by Foresee Pharmaceuticals Co., Ltd. at 21 sites in 5 countries.
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 23 inclusion and 19 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 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, South Korea, Lithuania, Czechia, Slovakia. 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?
Yes. Results are posted in the registry (first posted 4 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy of Leuprolide Mesylate (LMIS 25mg) (time frame: 168 days). 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 4 May 2020.