Prostate CancerPhase 2NEPTUNENCT03211052
A Study of Neoadjuvant TAK-700 and Leuprorelin Acetate Followed by Surgery Versus Surgery Alone
A Phase 2 study testing TAK-700 and LHRH agonist and prostatectomy in people with Prostate Cancer, run by Centre of Experimental Medicine at 1 site in United Kingdom.
Trial summary
This study investigates neoadjuvant TAK-700 orteronel for 6 months prior to prostatectomy. The three year biochemical free survival is the primary endpoint. There are a number of 2nd endpoints such as pathological complete response rate, the need for adjuvant radiation therapy, use of post operative radiotherapy an… 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?
- TAK-700 and LHRH agonist and prostatectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Feb 2013to 2 Jun 2015
- 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
- Willing and able to provide written informed consent
- No previous treatment for prostate cancer (including surgery, any hormone therapy, radiotherapy, cryotherapy).
- Age ≥ 18 years and male
- Histologically or cytologically confirmed adenocarcinoma of the prostate with Gleason score. A prostate biopsy within 6 months from screening is allowed for entry requirements.
- Intermediate or high risk prostate cancer according to National Comprehensive Cancer Network (NCCN) risk stratification criteria
- Intermediate: PSA >10 \& <20 or a Gleason score 7 or clinical stage up to and including T2c disease
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- High risk: PSA>20 or Gleason 8-10 or clinical stage >T2c
- Serum testosterone > 200 ng/dL
- Prostatectomy is the planned treatment option.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate organ function, defined as follows:
- Hemoglobin >10.0g/dL
- Absolute neutrophil count > 1.5 x 10.9/L
- Platelet count >100 x 10.9/L
- AST and /or ALT <2.5 x ULN
- Total Bilirubin <1.5 x ULN
Who cannot join
- Serious co-existent medical conditions such as chronic active autoimmune disease, (within the last 6 months) or infection (such as hepatitis).
- Uncontrolled hypertension within the screening period (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg). Patients with a history of hypertension are allowed to enrol provided blood pressure is controlled by anti-hypertensive therapy.
- Patients taking regular oral steroids for any reason.
- Previously treated prostate cancer (including radiotherapy, hormone therapy or surgery).
- History of pituitary or adrenal dysfunction
- Other active malignancy over the last 5 years that has required systemic therapy excluding:
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- Adjuvant therapy in the curative setting
- Non-melanoma skin cancer
- Superficial transitional cell carcinoma (CIS-T1).
- History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug
- Current enrolment in an investigational drug or device study or participation in such a study within 30 days of Day 1
- Not willing to comply with the procedural requirements of this protocol, including repeat prostate biopsies
- Patients who have partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 16 weeks after last study drug administration.
- Uncontrolled diabetes mellitus, in the opinion of the treating physician
- Known hypersensitivity to compounds related to TAK-700 or to TAK-700 excipients.
- Hypersensitivity to any of the ingredients or to synthetic Gn-RH or Gn-RH derivatives.
- Screening calculated ejection fraction of <50% by echocardiogram.
- History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade > 2 (NCI CTCAE, version 4.02), thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g., pericardial effusion restrictive cardiomyopathy) within 6 months prior to first dose of study drug. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
- New York Heart Association Class III or IV heart failure
- ECG abnormalities of Q-wave infarction, unless identified 6 or more months prior to screening
- QTc interval > 460 msec on ECG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Phase II Study of Neoadjuvant TAK-700 and Leuprorelin Acetate Followed by Surgery Versus Surgery Alone in Intermediate and High Risk Clinically Localized Prostate Cancer
This study investigates neoadjuvant TAK-700 orteronel for 6 months prior to prostatectomy. The three year biochemical free survival is the primary endpoint. There are a number of 2nd endpoints such as pathological complete response rate, the need for adjuvant radiation therapy, use of post operative radiotherapy an the rate of positive margins at surgery. Translational endpoints include measuring tumoural and plasma testosterone as well as other androgens.
Patients with untreated high risk and intermediate risk operable prostate cancer will be treated with TAK-700 (plus LHRH agonist) for 24 weeks prior to planned prostatectomy.
Read the detailed description
Study Objectives:
To investigate if neoadjuvant TAK-700 with LHRH agonists and prostatectomy is associated with a delay in progression free survival compared to prostatectomy alone
To evaluate response (CR and PR) after at least 12 and 24 weeks of treatment with the study drugs Collection of Plasma, tissue and functional imaging with MRI To evaluate (molecular) expression of AR regulated genes and tumour immunohistochemistry. Molecular and protein expression will be correlated with intracellular androgen levels and pathologic response to ADT
136 patients will be randomised to this study. 68 patients will receive neoadjuvant therapy with TAK-700 and Leuprorelin Acetate followed by surgery and 68 patients will receive surgery alone.
This trial aims to recruit 136 patients with clinically localised prostate cancer. Patients will be stratified according to National Comprehensive Cancer Network (NCCN) risk stratification criteria and type of planned surgery. Definitions of risk categories can be found in the inclusion and exclusion criteria.
- Conditions
- Prostate Cancer
- Being tested
- TAK-700 and LHRH agonist, prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-700 and LHRH agonistDrug
Also called Orteronel (TAK 700), LHRH-Leuprorelin Acetate
TAK-700 for 6 months 300mg BD with Leuprorelin Acetate Injections prior to planned prostatectomy
prostatectomyProcedure or surgery
SURGICAL REMOVAL OF THE PROSTATE
| Study group | Role | What they receive |
|---|---|---|
| TAK-700 + LHRH agonist + Prostatectomy | Experimental | Neoadjuvant TAK-700 for 6 months with LHRH agonists prior to prostatectomy Receives: Drug: TAK-700 and LHRH agonist |
| Prostatectomy | Other | Prostatectomy only-Within 28 days of randomisation Receives: Procedure: prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 year biochemical progression free survival (PSA)
Post-operative serum PSA of greater or equal to 0.2 ng/dl on 2 separate occasions as defined by the AUA.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start18 Feb 2013
- Primary completion2 Jun 2015
- Study completion2 Jun 2015
Why it stopped: IMP no longer available
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre of Experimental Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor-investigator, Centre of Experimental Medicine, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211052
- Sponsor's protocol ID
- 008285QM
- Acronym
- NEPTUNE
- Status last verified
- Jul 2017
- First submitted
- 26 Apr 2013
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Phase II Study of Neoadjuvant TAK-700 and Leuprorelin Acetate Followed by Surgery Versus Surgery Alone in Intermediate and High Risk Clinically Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT03211052
- Acronym / sponsor ID
- NEPTUNE / 008285QM
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IMP no longer available
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Centre of Experimental MedicineUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- 18 Feb 2013 (actual)
- Primary completion
- 2 Jun 2015 (actual)
- Study completion
- 2 Jun 2015 (actual)
- First posted
- 7 Jul 2017 (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.
This study investigates neoadjuvant TAK-700 orteronel for 6 months prior to prostatectomy. The three year biochemical free survival is the primary endpoint. There are a number of 2nd endpoints such as pathological complete response rate, the need for adjuvant radiation therapy, use of post operative radiotherapy an the rate of positive margins at surgery. Translational endpoints include measuring tumoural and plasma testosterone as well as other androgens.
Patients with untreated high risk and intermediate risk operable prostate cancer will be treated with TAK-700 (plus LHRH agonist) for 24 weeks prior to planned prostatectomy.
Detailed description
Study Objectives:
To investigate if neoadjuvant TAK-700 with LHRH agonists and prostatectomy is associated with a delay in progression free survival compared to prostatectomy alone
To evaluate response (CR and PR) after at least 12 and 24 weeks of treatment with the study drugs Collection of Plasma, tissue and functional imaging with MRI To evaluate (molecular) expression of AR regulated genes and tumour immunohistochemistry. Molecular and protein expression will be correlated with intracellular androgen levels and pathologic response to ADT
136 patients will be randomised to this study. 68 patients will receive neoadjuvant therapy with TAK-700 and Leuprorelin Acetate followed by surgery and 68 patients will receive surgery alone.
This trial aims to recruit 136 patients with clinically localised prostate cancer. Patients will be stratified according to National Comprehensive Cancer Network (NCCN) risk stratification criteria and type of planned surgery. Definitions of risk categories can be found in the inclusion and exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAK-700 + LHRH agonist + Prostatectomy | Experimental | Drug: TAK-700 and LHRH agonistNeoadjuvant TAK-700 for 6 months with LHRH agonists prior to prostatectomy |
| Prostatectomy | Other | Procedure: prostatectomyProstatectomy only-Within 28 days of randomisation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Willing and able to provide written informed consent
- No previous treatment for prostate cancer (including surgery, any hormone therapy, radiotherapy, cryotherapy).
- Age ≥ 18 years and male
- Histologically or cytologically confirmed adenocarcinoma of the prostate with Gleason score. A prostate biopsy within 6 months from screening is allowed for entry requirements.
- Intermediate or high risk prostate cancer according to National Comprehensive Cancer Network (NCCN) risk stratification criteria
Key exclusion criteria (21 listed)
- Serious co-existent medical conditions such as chronic active autoimmune disease, (within the last 6 months) or infection (such as hepatitis).
- Uncontrolled hypertension within the screening period (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg). Patients with a history of hypertension are allowed to enrol provided blood pressure is controlled by anti-hypertensive therapy.
- Patients taking regular oral steroids for any reason.
- Previously treated prostate cancer (including radiotherapy, hormone therapy or surgery).
- History of pituitary or adrenal dysfunction
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 |
|---|---|---|
| TAK-700 and LHRH agonistAlso: Orteronel (TAK 700), LHRH-Leuprorelin AcetateTAK-700 for 6 months 300mg BD with Leuprorelin Acetate Injections prior to planned prostatectomy | Drug | TAK-700 + LHRH agonist + Prostatectomy |
| prostatectomySURGICAL REMOVAL OF THE PROSTATE | Procedure or surgery | Prostatectomy |
Primary outcome
3 year biochemical progression free survival (PSA)
Time frame: 3 years
Post-operative serum PSA of greater or equal to 0.2 ng/dl on 2 separate occasions as defined by the AUA.
Results and safety
The study was stopped early (reason given: IMP no longer available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
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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?
A Phase 2 study testing TAK-700 and LHRH agonist and prostatectomy in people with Prostate Cancer, run by Centre of Experimental Medicine at 1 site in United Kingdom.
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 16 inclusion and 21 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: stopped early, as of the sponsor's last update on 7 Jul 2017. 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 United Kingdom. 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?
The study was stopped early (reason given: IMP no longer available). Results are not available in the source record.
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?
3 year biochemical progression free survival (PSA) (time frame: 3 years). 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 7 Jul 2017.