Bladder CancerPhase 2NCT02605863
Enzalutamide for Bladder Cancer Chemoprevention
A Phase 2 study testing Enzalutamide in people with Bladder Cancer, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect of androgen deprivation therapy through administration of enzalutamide on preventing bladder cancer recurrences in patients with non-muscle invasive bladder cancer (NMIBC). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Enzalutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Feb 2018
- Phase
- Phase 2
- 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
- Subjects with histologically confirmed NMIBC who have undergone their TURBT.
- Per the European Association of Urology (EAU) guidelines, only subjects with "Intermediate" or "High risk" bladder cancer will be enrolled21:
- For patients with "high risk" bladder cancer, only those who undergo BCG therapy following their TURBT will be eligible for enrollment.
- Subjects who receive BCG instillations post-operatively will be eligible for enrollment.
- Subjects whose tumors are AR(+) as well as AR(-) will be included, but we will restrict inclusion of AR(-) subjects so that they represent no more than 1/3 of the total study population, or any single cohort (ie. the intermediate or high-risk groups).
- Subjects of child-bearing potential must agree to 2 acceptable forms of birth control.
Who cannot join
- Subjects with "low risk" bladder cancer, as defined by the EAU guidelines21, will be ineligible for enrollment.
- Subjects with "high risk" bladder cancer who do not undergo BCG therapy following their TURBT will be ineligible for enrollment.
- Subjects who have "failed" BCG therapy in the past (had a recurrence of bladder cancer despite prior use of BCG) will be ineligible for enrollment.
- Subjects who receive an immediate post-TURBT single instillation of intravesical chemotherapy will be ineligible for enrollment.
- Subjects who receive a post-operative induction course of intravesical chemotherapy (ie. more than just a single immediate post-operative dose of intravesical chemotherapy) will be ineligible for enrollment.
- Subjects who undergo blue-light/fluorescence cystoscopy will be ineligible for enrollment.
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- Subjects with a history of heart attack within the previous 12 months or who have unstable cardiovascular status will be ineligible for enrollment.
- Subjects who have uncontrolled hypertension (for our purposes, defined as those having a systolic blood pressure > 160 documented on 2 occasions despite appropriate medical therapy) will similarly be ineligible.
- Subjects with a history of venous thrombo-embolism (DVT/PE) within the past 3 years.
- Subjects with a history of seizure disorders, or those with a history of stroke or transient ischemic attacks (TIA) within the previous 12 months will be ineligible.
- Subjects with a history of liver disease whose hepatic enzymes, alkaline phosphatase or bilirubin are greater than twice the upper limit of normal will be ineligible.
- Subjects with kidney disease with an estimated glomerular filtration rate (eGFR) < 30 will be ineligible.
- Subjects with neutropenia will be ineligible.
- Subjects with clinical hypogonadism, those on androgen replacement therapy, or those with prostate cancer or other diseases treated with various forms of hormonal therapy (not including 5-alpha reductase inhibitors) will also be ineligible for study enrollment.
- Subjects who have undergone therapy for any malignancy within the past 5 years except for basal and squamous cell carcinomas of the skin will also be ineligible.
- Subjects with prior histories of prostate cancer treated by definitive local therapy > 5 years ago will only be eligible if they have had no clinical or biochemical evidence of recurrent prostate cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Androgen Deprivation Therapy With Enzalutamide on Bladder Cancer Chemoprevention
The purpose of this study is to examine the effect of androgen deprivation therapy through administration of enzalutamide on preventing bladder cancer recurrences in patients with non-muscle invasive bladder cancer (NMIBC).
Read the detailed description
- A blood draw and an electrocardiogram (EKG). The blood draw will check levels of testosterone, dihydro-testosterone, estradiol, and Vitamin D. Pre-study blood-work will also include a complete blood count (CBC), basic metabolic panel (BMP/CHEM8) and liver function test (LFT) if any of these labs were not drawn within 1 month prior to the transurethral resection of bladder tumor (TURBT).
- Bladder tumor sample that is stored in the Department of Pathology will have additional tests run on it to confirm study eligibility and to test for certain cell markers.
- After 1 month following the original TURBT, subjects will begin therapy with enzalutamide. The study drug will be administered orally at a dose of 160mg daily for 12 months.
- Subjects will be monitored for adverse reactions or side effects from enzalutamide at scheduled office visits.
- If the bladder tumor is classified as being "intermediate risk", regularly scheduled office visits will occur at 2 months post-operatively (i.e., 1 month after starting enzalutamide), and then again at post-operative months 3, 6, 9 and 12, as is part of the usual standard of care.
- If the bladder tumor is classified as being "high risk" and the subject receives BCG therapy, then the office visits will occur on a slightly different schedule to conform to the standard of care for this type of disease. Subjects in this group typically start their intravesical BCG instillations 4-6 weeks post-operatively. Therefore, the subjects will be seen approximately 1 month following the initial TURBT, and will begin therapy with enzalutamide at that time, as described above. Subjects will be on study drug at least 7 days prior to the initiation of BCG therapy, which will occur once a week for 6 weeks. Similar to the subjects in the intermediate risk group, the subjects receiving BCG will also be seen 1 month after initiation of enzalutamide therapy to ensure there are no adverse reactions to the study drug. Following this visit, they will be seen again at the time of the post-BCG cystoscopy, which occurs 1 month after your 6th instillation. Subjects will be seen again at the 3, 6, 9 and 12-month post-BCG cystoscopy office visits, as part of routine care.
- Repeat blood work (CBC, BMP and LFTs) will be checked 1 month after starting enzalutamide (approximately 2 months post-operatively). For subjects with intermediate risk bladder cancer, these labs will be checked again at 3, 6, 9 and 12 months post-operatively (as per the regularly scheduled office visits). For the high risk patients receiving BCG therapy, these labs will be checked again at the 1, 3, 6 and 9-month post-BCG office visits (per the regularly scheduled office visits for these patients).
- An EKG will be obtained at baseline (before starting the study drug), but will also be re-checked at approximately 6 months (half-way through therapy with enzalutamide) to ensure there are no signs of worsening cardiac disease while on the study drug.
- A cystoscopy will be done every 3 months as part of the standard of care for bladder cancer follow-up. Lesions suspicious for tumor recurrence will be biopsied as per usual standard of care. If a recurrence is documented, subjects will discontinue use of enzalutamide.
- For subjects scheduled to undergo therapy with BCG, additional tests will be run on the urine samples that subjects will already be providing in the Urology office as part of the standard of care.
- Conditions
- Bladder Cancer
- Being tested
- Enzalutamide
- Keywords
- Enzalutamide, Non-Muscle Invasive Bladder Cancer, Androgen Deprivation Therapy
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzalutamideDrug
Also called Xtandi
160 mg by mouth daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Intermediate Risk NMIBC | Experimental | Enzalutamide 160mg by mouth daily for 12 months Receives: Drug: Enzalutamide |
| High Risk NMIBC | Experimental | Enzalutamide 160mg by mouth daily for 12 months Receives: Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Recurrent Disease
Bladder cystoscopy, urine cytology, and pathology report
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Why it stopped: Low enrollment, sponsor withdrew support for study
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 Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Principal investigator, Edward Messing, University of Rochester
- Investigators
- Edward E. Messing, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605863
- Sponsor's protocol ID
- 52539
- Status last verified
- Sep 2018
- First submitted
- 12 Nov 2015
- Last updated
- 3 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Androgen Deprivation Therapy With Enzalutamide on Bladder Cancer Chemoprevention
- ClinicalTrials.gov ID
- NCT02605863
- Acronym / sponsor ID
- 52539
- Conditions
- Bladder Cancer
- Keywords
- Enzalutamide, Non-Muscle Invasive Bladder Cancer, Androgen Deprivation Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment, sponsor withdrew support for study
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Jan 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 16 Nov 2015 (estimated)
- Results
- Posted 7 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effect of androgen deprivation therapy through administration of enzalutamide on preventing bladder cancer recurrences in patients with non-muscle invasive bladder cancer (NMIBC).
Detailed description
- A blood draw and an electrocardiogram (EKG). The blood draw will check levels of testosterone, dihydro-testosterone, estradiol, and Vitamin D. Pre-study blood-work will also include a complete blood count (CBC), basic metabolic panel (BMP/CHEM8) and liver function test (LFT) if any of these labs were not drawn within 1 month prior to the transurethral resection of bladder tumor (TURBT).
- Bladder tumor sample that is stored in the Department of Pathology will have additional tests run on it to confirm study eligibility and to test for certain cell markers.
- After 1 month following the original TURBT, subjects will begin therapy with enzalutamide. The study drug will be administered orally at a dose of 160mg daily for 12 months.
- Subjects will be monitored for adverse reactions or side effects from enzalutamide at scheduled office visits.
- If the bladder tumor is classified as being "intermediate risk", regularly scheduled office visits will occur at 2 months post-operatively (i.e., 1 month after starting enzalutamide), and then again at post-operative months 3, 6, 9 and 12, as is part of the usual standard of care.
- If the bladder tumor is classified as being "high risk" and the subject receives BCG therapy, then the office visits will occur on a slightly different schedule to conform to the standard of care for this type of disease. Subjects in this group typically start their intravesical BCG instillations 4-6 weeks post-operatively. Therefore, the subjects will be seen approximately 1 month following the initial TURBT, and will begin therapy with enzalutamide at that time, as described above. Subjects will be on study drug at least 7 days prior to the initiation of BCG therapy, which will occur once a week for 6 weeks. Similar to the subjects in the intermediate risk group, the subjects receiving BCG will also be seen 1 month after initiation of enzalutamide therapy to ensure there are no adverse reactions to the study drug. Following this visit, they will be seen again at the time of the post-BCG cystoscopy, which occurs 1 month after your 6th instillation. Subjects will be seen again at the 3, 6, 9 and 12-month post-BCG cystoscopy office visits, as part of routine care.
- Repeat blood work (CBC, BMP and LFTs) will be checked 1 month after starting enzalutamide (approximately 2 months post-operatively). For subjects with intermediate risk bladder cancer, these labs will be checked again at 3, 6, 9 and 12 months post-operatively (as per the regularly scheduled office visits). For the high risk patients receiving BCG therapy, these labs will be checked again at the 1, 3, 6 and 9-month post-BCG office visits (per the regularly scheduled office visits for these patients).
- An EKG will be obtained at baseline (before starting the study drug), but will also be re-checked at approximately 6 months (half-way through therapy with enzalutamide) to ensure there are no signs of worsening cardiac disease while on the study drug.
- A cystoscopy will be done every 3 months as part of the standard of care for bladder cancer follow-up. Lesions suspicious for tumor recurrence will be biopsied as per usual standard of care. If a recurrence is documented, subjects will discontinue use of enzalutamide.
- For subjects scheduled to undergo therapy with BCG, additional tests will be run on the urine samples that subjects will already be providing in the Urology office as part of the standard of care.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermediate Risk NMIBC | Experimental | Drug: EnzalutamideEnzalutamide 160mg by mouth daily for 12 months |
| High Risk NMIBC | Experimental | Drug: EnzalutamideEnzalutamide 160mg by mouth daily for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with histologically confirmed NMIBC who have undergone their TURBT.
- Per the European Association of Urology (EAU) guidelines, only subjects with "Intermediate" or "High risk" bladder cancer will be enrolled21:
- For patients with "high risk" bladder cancer, only those who undergo BCG therapy following their TURBT will be eligible for enrollment.
- Subjects who receive BCG instillations post-operatively will be eligible for enrollment.
- Subjects whose tumors are AR(+) as well as AR(-) will be included, but we will restrict inclusion of AR(-) subjects so that they represent no more than 1/3 of the total study population, or any single cohort (ie. the intermediate or high-risk groups).
Key exclusion criteria (16 listed)
- Subjects with "low risk" bladder cancer, as defined by the EAU guidelines21, will be ineligible for enrollment.
- Subjects with "high risk" bladder cancer who do not undergo BCG therapy following their TURBT will be ineligible for enrollment.
- Subjects who have "failed" BCG therapy in the past (had a recurrence of bladder cancer despite prior use of BCG) will be ineligible for enrollment.
- Subjects who receive an immediate post-TURBT single instillation of intravesical chemotherapy will be ineligible for enrollment.
- Subjects who receive a post-operative induction course of intravesical chemotherapy (ie. more than just a single immediate post-operative dose of intravesical chemotherapy) will be ineligible for enrollment.
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 |
|---|---|---|
| EnzalutamideAlso: Xtandi160 mg by mouth daily for 12 months | Drug | High Risk NMIBC, Intermediate Risk NMIBC |
Primary outcome
Number of Participants With Recurrent Disease
Time frame: 1 year
Bladder cystoscopy, urine cytology, and pathology report
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- 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.
Edward E. Messing, MD principal investigator
University of Rochester
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 Enzalutamide in people with Bladder Cancer, run by University of Rochester at 1 site in United States.
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 6 inclusion and 16 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 3 Oct 2018. 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 States. 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?
Yes. Results are posted in the registry (first posted 7 May 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?
Number of Participants With Recurrent Disease (time frame: 1 year). 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 3 Oct 2018.