Adenocarcinoma of the ProstatePhase 2NCT01927627
Enzalutamide in Patients With High-risk Prostate Cancer
A Phase 2 study testing enzalutamide in people with Adenocarcinoma of the Prostate, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to see how long it takes for prostate cancer to come back in patients who have had surgery to remove their prostate gland (radical prostatectomy), while being treated with enzalutamide (formerly known as MDV3100). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate
- 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
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2013to 26 Apr 2017
- 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
- Understand and voluntarily sign an informed consent form.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically confirmed adenocarcinoma of the prostate.
- Patients must have undergone a Radical Prostatectomy (any surgical technique is permitted) within 3 months from study entry and have high-risk disease define by any of the following:
- Pathological stage T3a, T3b, T4 (any grade or iPSA)
- Gleason' sum ≥ 8 (any stage or iPSA)
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- Initial Pre-operative PSA ≥ 20ng/mL (any GS or pT stage)
- Any stage/PSA/Gleason patients with a 35% or greater chance of biochemical failure at 5 years based on Kattan's nomogram http://nomograms.mskcc.org/Prostate/PostRadicalProstatectomy.
- Patients with Lymph node (LN) positive disease, regardless of iPSA, pT stage or GS provided their post-operative PSA 6-8 weeks after surgery is ≤ 0.4ng/mL. (Lymph node dissection is desired but not mandated)
- Able to swallow the study drug and comply with study requirements.
- Patients must have normal organ and marrow function as defined below:
- Testosterone ≥ 50 ng/dL per laboratory reference range
- Baseline Post-RP PSA ≤ 0.4
- Hemoglobin ≥ 10.0 g/dL independent of transfusion
- Absolute neutrophil count ≥1,500/mcL
- Platelet count ≥100,000/ìL
- Serum albumin ≥ 3.5 g/dL
- Serum potassium ≥ 3.5 mmol/L
- Liver function: serum bilirubin < 1.5 x ULN (except for patients with documented Gilbert's disease) and AST or ALT < 2.5 x ULN
Who cannot join
- Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment
- Prior radiotherapy to the prostate or pelvis (related to prostate cancer). Concurrent adjuvant radiation therapy is permitted once patient has been enrolled on trial.
- Prior use of Abiraterone acetate or cytotoxic chemotherapy for prostate cancer
- Prior androgen deprivation with Luteinizing hormone-releasing hormone (LHRH) is permitted provided that testosterone levels prior to study entry have recovered to normal limits per reference laboratory.
- No prior anti-androgen therapy (bicalutamide, flutamide or Nilutamide) is permitted
- Prior use of 5-alpha reductase inhibitors is permitted provided such medications were stopped 7-14 days prior to enrollment
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- Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 2 weeks of enrollment
- Active unresolved infection
- Known history of central nervous system (CNS) metastases
- Patients must have no known history of HIV
- Evidence of metastatic disease as evidenced by a CT or MRI of abdomen and pelvis and/or whole body bone scan (WBS). To be done prior to treatment start and up to 4 months prior to radical prostatectomy date.
- History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma). Also, history of loss of consciousness or transient ischemic attack within 12 months of enrollment.
- Clinically significant cardiovascular disease including:
- Myocardial infarction within 6 months prior to Screening;
- Uncontrolled angina within 3 months prior to Screening;
- Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is ≥ 45%
- History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)
- History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place
- Hypotension as indicated by systolic blood pressure < 86 mmHg at the Screening visit
- Bradycardia as indicated by a heart rate of < 50 beats per minute on the Screening ECG
- Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the Screening visit
- Gastrointestinal disorder affecting absorption (e.g., Gastrectomy, active peptic ulcer disease within last 3 months)
- Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data.
- The effects of enzalutamide on the developing human fetus at the recommended therapeutic doses are unknown. Thus, men must agree to use adequate contraception (barrier method of birth control or abstinence) prior to study entry, for the duration of study participation, and for 6 months after the usage of enzalutamide. Should the patient's partner become pregnant or suspect she is pregnant while the patient is participating in this study, the patient should inform his treating physician immediately.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: A Phase 2 Study of Enzalutamide in Patients With High-risk Prostate Cancer Who Have Undergone Local Definitive Therapy With Radical Prostatectomy
The purpose of this study is to see how long it takes for prostate cancer to come back in patients who have had surgery to remove their prostate gland (radical prostatectomy), while being treated with enzalutamide (formerly known as MDV3100).
Enzalutamide is known as an androgen-receptor signaling inhibitor, which means that it blocks activity of the male hormone, testosterone. Most prostate cancers are dependent on testosterone for growth. In this study, patients will take enzalutamide after surgery to see if it keeps their cancer from coming back.
Read the detailed description
This is a pilot phase II study evaluating the clinical activity and safety of Enzalutamide (formerly known as MDV3100) a novel androgen receptor (AR) inhibitor in men with high-risk prostate cancer who have undergone local definitive therapy with radical prostatectomy.
Primary Objectives:
-To evaluate the clinical efficacy of enzalutamide in patients with high-risk prostate cancer with regards to: Time to disease progression defined by biochemical recurrence (BCR)
Secondary Objectives:
-To further evaluate the safety of enzalutamide in patients with high-risk prostate cancer
Patients will receive daily oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD). Patients will continue on study until progressive disease, drug intolerability, consent withdrawal or completion of study at 24 months.
- Conditions
- Adenocarcinoma of the Prostate
- Being tested
- enzalutamide
- Keywords
- Prostate cancer, adenocarcinoma of the prostate, Enzalutamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enzalutamideDrug
Also called XTANDI, MDV3100
oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).
| Study group | Role | What they receive |
|---|---|---|
| Enzalutamide | Experimental | Oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD). Receives: Drug: enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate the Clinical Efficacy of Enzalutamide
Clinical efficacy is measured as time to disease progression defined by biochemical recurrence (BCR). BCR was defined as PSA ≥0.2ng/mL on 2 consecutive lab results or any PSA rise that resulted in subsequent therapy.
Measured: 2 years
Secondary outcomes (1)
Safety of Enzalutamide
The number of patients that experience adverse events related to the study drug. NCI Cancer Clinical Trials Common Toxicity Criteria (version 4.0) will be utilized.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2013 (estimated)
- Study start11 Nov 2013
- Primary completion29 Mar 2017
- Study completion26 Apr 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 Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge Garcia, MD, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927627
- Sponsor's protocol ID
- CASE12812
- Other IDs
- NCI-2013-01661
- Status last verified
- Mar 2019
- First submitted
- 19 Aug 2013
- Last updated
- 20 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Enzalutamide in Patients With High-risk Prostate Cancer Who Have Undergone Local Definitive Therapy With Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT01927627
- Acronym / sponsor ID
- CASE12812
- Conditions
- Adenocarcinoma of the Prostate
- Keywords
- Prostate cancer, adenocarcinoma of the prostate, Enzalutamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 11 Nov 2013 (actual)
- Primary completion
- 29 Mar 2017 (actual)
- Study completion
- 26 Apr 2017 (actual)
- First posted
- 22 Aug 2013 (estimated)
- Results
- Posted 12 Mar 2019
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 see how long it takes for prostate cancer to come back in patients who have had surgery to remove their prostate gland (radical prostatectomy), while being treated with enzalutamide (formerly known as MDV3100).
Enzalutamide is known as an androgen-receptor signaling inhibitor, which means that it blocks activity of the male hormone, testosterone. Most prostate cancers are dependent on testosterone for growth. In this study, patients will take enzalutamide after surgery to see if it keeps their cancer from coming back.
Detailed description
This is a pilot phase II study evaluating the clinical activity and safety of Enzalutamide (formerly known as MDV3100) a novel androgen receptor (AR) inhibitor in men with high-risk prostate cancer who have undergone local definitive therapy with radical prostatectomy.
Primary Objectives:
-To evaluate the clinical efficacy of enzalutamide in patients with high-risk prostate cancer with regards to: Time to disease progression defined by biochemical recurrence (BCR)
Secondary Objectives:
-To further evaluate the safety of enzalutamide in patients with high-risk prostate cancer
Patients will receive daily oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD). Patients will continue on study until progressive disease, drug intolerability, consent withdrawal or completion of study at 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enzalutamide | Experimental | Drug: enzalutamideOral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Understand and voluntarily sign an informed consent form.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically confirmed adenocarcinoma of the prostate.
- Patients must have undergone a Radical Prostatectomy (any surgical technique is permitted) within 3 months from study entry and have high-risk disease define by any of the following:
- Able to swallow the study drug and comply with study requirements.
Key exclusion criteria (24 listed)
- Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment
- Prior radiotherapy to the prostate or pelvis (related to prostate cancer). Concurrent adjuvant radiation therapy is permitted once patient has been enrolled on trial.
- Prior use of Abiraterone acetate or cytotoxic chemotherapy for prostate cancer
- Prior androgen deprivation with Luteinizing hormone-releasing hormone (LHRH) is permitted provided that testosterone levels prior to study entry have recovered to normal limits per reference laboratory.
- No prior anti-androgen therapy (bicalutamide, flutamide or Nilutamide) is permitted
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: XTANDI, MDV3100oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD). | Drug | Enzalutamide |
Primary outcome
To Evaluate the Clinical Efficacy of Enzalutamide
Time frame: 2 years
Clinical efficacy is measured as time to disease progression defined by biochemical recurrence (BCR). BCR was defined as PSA ≥0.2ng/mL on 2 consecutive lab results or any PSA rise that resulted in subsequent therapy.
1 secondary outcome
Safety of Enzalutamide
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 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.
Jorge Garcia, MD principal investigator
Case Comprehensive Cancer Center
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 Adenocarcinoma of the Prostate, run by Case Comprehensive Cancer Center 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 19 inclusion and 24 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 20 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 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 12 Mar 2019). 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?
To Evaluate the Clinical Efficacy of Enzalutamide (time frame: 2 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 20 Mar 2019.