Prostatic NeoplasmsPhase 3NCT02234115
Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma
A Phase 3 study testing Leuprolide Mesylate in people with Prostatic Neoplasms, run by Foresee Pharmaceuticals Co., Ltd. at 29 sites in 8 countries.
Trial summary
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. 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
- 137 participants
- Where
- 29 sitesin 8 countries
- Study dates
- Aug 2014to 5 Jan 2017
- 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 judgment
- HgbA1c within acceptable range according to investigator's judgment
- 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 Baseline
- History of blood donation within 2 months of Baseline
- History of anaphylaxis to any LH-RH analogues
- Receipt of any LHRH suppressive therapy within 6 months of Baseline
- Major surgery, including any prostatic surgery, within 4 weeks of Baseline
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- History and concomitant clinical and radiographic evidence of central nervous system/spinal cord metastases. Subjects at risk for spinal cord compression will be excluded.
- 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 Baseline
- History or presence of insulin-dependent diabetes mellitus (Type I). Presence of well controlled diabetes mellitus Type II will be allowed
- Use of systemic corticosteroids at a dose >10 mg/d or anti-androgens
- Use of any investigational agent within 4 weeks of Baseline
- Use of any over-the-counter (OTC) medication within 4 weeks of Baseline 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
29 sites in 8 countries.
29 sites in 8 countries
United States8 sites
Seattle Urology Research Center
Burien, Washington, 98166
Carolina Clinical Trials, LLC
Concord, North Carolina, 28025
Urology Centers of Alabama
Homewood, Alabama, 35209
Alliance Research Centers
Laguna Hills, California, 92653
AdvanceMed Research
Lawrenceville, New Jersey, 08648
Idaho Urologic Institute - Meridian
Meridian, Idaho, 83642
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Genesis Research, LLC
San Diego, California, 92123
Taiwan6 sites
Kaohsiung Veteran General Hospital (VGHKS)
Kaohsiung City, Pingtung, 813
China Medical University Hospital (CMUH)
Taichung, Taichung, 404
Taichung Veteran General Hospital (VGHTC)
Taichung, Taichung, 407
National Cheng Kung University Hospital (NCKUH)
Tainan, Tainan, 704
National Taiwan University Hospital (NTUH)
Taipei City, Taipei, 100
Chang Gung Memorial Hospital, LinKou (CGMH-LK)
Taoyuan City, 333
Poland4 sites
Uniwersyteckie Centrum Kliniczne, Klinika Urologii
Gdansk, 80-402
"DERMED" Centrum Medyczne Sp. z o.o.
Lodz, 90-265
Centralny Szpital Kliniczny MSW w Warszawie, Klinika Urologii i Urologii Onkologicznej
Warzawa, Warzawa, 02-507
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Układu Moczowego
Warzawa, Warzawa, 02-781
Czechia3 sites
University Hospital Hradec Králové
Hradec Králové, 500 05
University Hospital Olomouc
Olomouc, 779 00
Thomayerova nemocnice Urologické oddělení
Prague, Praha 4 - Krč, 140 59
Lithuania3 sites
PI Hospital of Lithuanian University of Health Sciences, Kauno Klinikos
Kaunas, 50009
PI Klaipėda University Hospital
Klaipėda, 92288
PI Vilnius University Hospital, Santariškių Klinikos
Vilnius, 08661
Austria2 sites
AKH Linz GmbH, Department of Urology
Linz, Upper Austria, 4020
Universitätsklinik für Urologie und Andrologie, Landeskrankenhaus Salzburg (University hospital for Urology and Andrology)
Salzburg, 5020
Slovakia2 sites
UROCENTRUM MILAB, s.r.o.
Prešov
Fakultná nemocnica s poliklinikou Žilina Urológia
Žilina, 012 07
Germany1 site
Universitätsklinikum RWTH Aachen, Klinik für Urologie
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: An Open-Labeled, Singled-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects With Advanced Prostate Carcinoma
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.
Read the detailed description
This is a multi-center, open-label, single-arm study conducted in 2 parts. Part I was established to provide a vanguard of the first 30 subjects who will have more frequent monitoring of their safety. If safety is established, the remainder of the subjects will be entered into the clinical study (i.e., Part II). All subjects will be males with advanced prostate carcinoma judged to be candidates for medical androgen ablation therapy, and all will receive two injections of LMIS 50 mg six-month 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 50mg Leuprolide Mesylate
| Study group | Role | What they receive |
|---|---|---|
| Leuprolide Mesylate 50mg | Experimental | All subjects will be males with advanced prostate carcinoma. They will be injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects will be followed until day 336. 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 50mg)
The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) following the first injection of LMIS 50 mg from Day 28 through Day 336 (remaining duration of the study).
Measured: baseline to 28 days, 28 days to 336 days
Secondary outcomes (1)
Number of Participants With Adverse Events (AEs)
Safety analysis was based on the safety information from the laboratory evaluations, AEs, and SAEs.
Measured: 336 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startAug 2014
- Primary completion30 Aug 2016
- Study completion5 Jan 2017
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
- 137 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
- NCT02234115
- Sponsor's protocol ID
- FP01C-13-001
- Other IDs
- 2013-001790-25
- Status last verified
- Feb 2019
- First submitted
- 1 Sep 2014
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Labeled, Singled-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects With Advanced Prostate Carcinoma
- ClinicalTrials.gov ID
- NCT02234115
- Acronym / sponsor ID
- FP01C-13-001
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostate Neoplasm Cancer Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Foresee Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 5 Jan 2017 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Posted 13 Apr 2018
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 advanced prostate carcinoma, when administered as two injections six months apart.
Detailed description
This is a multi-center, open-label, single-arm study conducted in 2 parts. Part I was established to provide a vanguard of the first 30 subjects who will have more frequent monitoring of their safety. If safety is established, the remainder of the subjects will be entered into the clinical study (i.e., Part II). All subjects will be males with advanced prostate carcinoma judged to be candidates for medical androgen ablation therapy, and all will receive two injections of LMIS 50 mg six-month 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 50mg | Experimental | Drug: Leuprolide MesylateAll subjects will be males with advanced prostate carcinoma. They will be injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects will be followed until day 336. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 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 Baseline
- History of blood donation within 2 months of Baseline
- History of anaphylaxis to any LH-RH analogues
- Receipt of any LHRH suppressive therapy within 6 months of Baseline
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 50mg Leuprolide Mesylate | Drug | Leuprolide Mesylate 50mg |
Primary outcome
Efficacy of Leuprolide Mesylate (LMIS 50mg)
Time frame: baseline to 28 days, 28 days to 336 days
The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) following the first injection of LMIS 50 mg from Day 28 through Day 336 (remaining duration of the study).
1 secondary outcome
Number of Participants With Adverse Events (AEs)
Time frame: 336 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- 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.
29 sites in 8 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 29 sites in 8 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 22 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 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Taiwan, Poland, Czechia, Lithuania and 3 more countries. 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 13 Apr 2018). 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 50mg) (time frame: baseline to 28 days, 28 days to 336 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 5 Mar 2019.