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Prostate CancerPhase 2NCT01302041

A Study to Test if Enzalutamide is Effective and Safe in Prostate Cancer Patients Who Have Never Had Hormone Therapy

A Phase 2 study testing Enzalutamide in people with Prostate Cancer, run by Astellas Pharma Inc at 12 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To evaluate the effect of enzalutamide on prostate specific antigen (PSA) level in men with prostate cancer. 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?
Enzalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
12 sitesin 4 countries
Study dates
6 May 2011to 27 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

  • Histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant therapy)
  • Asymptomatic from prostate cancer
  • Non-castrate level of testosterone (≥ 8 nmol/L (230 ng/dL)) at screening
  • PSA ≥ 2 ng/mL at screening

Who cannot join

  • Has previously or is currently receiving:
  • Hormonal therapy with intent to treat prostate cancer
  • Systemic glucocorticoids
  • Chemotherapy with the intent to treat prostate cancer
  • Opiate analgesics for pain from prostate cancer
  • Radiation therapy for treatment of the primary tumor or metastases
Show all 9Show fewer
  • Has history of known or suspected brain or skull metastases or leptomeningeal disease
  • Has history of seizure including febrile seizure or any condition that may predispose to seizure or history of loss of consciousness or transient ischemic attack
  • Clinically significant cardiovascular disease

Trial locations and contacts

12 sites in 4 countries.

12 sites in 4 countries

Belgium4 sites

  • Site BE1003

    Brussels, 1090

  • Site BE1001

    Brussels, 1200

  • Site BE1002

    Kortrijk, 8500

  • Site BE1005

    Leuven, 3000

Other trials in Belgium

Denmark3 sites

  • Site DK4001

    Aarhus N, 8200

  • Site DK4004

    Copenhagen, DK-2100

  • Site DK4002

    Herlev, 2730

Other trials in Denmark

Germany3 sites

  • Site DE5005

    Aachen, 51074

  • Site DE5007

    Bonn, 53111

  • Site DE5003

    Hanover, 30625

Other trials in Germany

Czechia2 sites

  • Site CZ3006

    Olomouc, 77520

  • Site CZ3002

    Prague, 16000

Other trials in Czechia

About this study

Official title: A Phase 2, Open-label, Single-arm, Efficacy and Safety Study of Enzalutamide (MDV3100) in Patients With Hormone-naïve Prostate Cancer

To evaluate the effect of enzalutamide on prostate specific antigen (PSA) level in men with prostate cancer.

Conditions
Prostate Cancer
Being tested
Enzalutamide
Keywords
bone turnover, hormone-naïve, prostate specific antigen, Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01302041
Study groupRoleWhat they receive
EnzalutamideExperimentalParticipants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
Receives: Drug: Enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With a Prostate-Specific Antigen (PSA) Response at Week 25

    A PSA response was defined as a decline from Baseline in PSA level of 80% or greater. Blood samples for PSA were collected and analyzed at a central laboratory. Participants with an unknown or missing response or who discontinued prior to week 25 for any reason were treated as non-responders.

    Measured: Baseline and Week 25

Secondary outcomes (25)

  1. Number of Participants With Adverse Events

    Each adverse event (AE) was assessed by the investigator for causal relationship to the study drug; those deemed possibly or probably related to study drug are reported as drug regimen related AEs (DRRAEs).

    A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose:

    • Resulted in death
    • Was life-threatening
    • Resulted in persistent or significant disability/incapacity
    • Resulted in congenital anomaly or birth defect
    • Required inpatient hospitalization or led to prolongation of hospitalization
    • Other medically important events.

    Measured: From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)

  2. Percent Change From Baseline in PSA

    Measured: Baseline and Weeks 25, 49, 97, 169 and Week 265 (End of Study)

  3. Percent Change From Baseline in Sex Hormone-Binding Globulin (SHBG)

    Measured: Baseline and Weeks 25 and 49

  4. Percent Change From Baseline in Androstenedione

    Measured: Baseline and Weeks 25 and 49

  5. Percent Change From Baseline in Dehydroepiandrosterone (DHEA)

    Measured: Baseline and Weeks 25 and 49

  6. Percent Change From Baseline in Dihydrotestosterone (DHT)

    Measured: Baseline and Week 25 and 49

  7. Percent Change From Baseline in Estradiol

    Measured: Baseline and Weeks 25 and 49

  8. Percent Change From Baseline in Follicle-Stimulating Hormone (FSH)

    Measured: Baseline and Weeks 25 and 49

  9. Percent Change From Baseline in Luteinizing Hormone (LH)

    Measured: Baseline and Weeks 25 and 49

  10. Percent Change From Baseline in Prolactin

    Measured: Baseline and Weeks 25 and 49

  11. Percent Change From Baseline in Total Testosterone

    Measured: Baseline and Weeks 25 and 49

  12. Percent Change From Baseline in Free Testosterone

    Measured: Baseline and Weeks 25 and 49

  13. Plasma Concentration of Enzalutamide at Pre-dose (Ctrough)

    Measured: Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25

  14. Plasma Concentration of Enzalutamide Metabolite M2 at Pre-dose (Ctrough)

    Measured: Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25

  15. Percentage of Participants With a PSA Response at Weeks 49, 97 and 169

    A PSA response was defined as a decline from baseline in PSA level of 80% or greater. Blood samples for PSA were collected and analyzed at a central laboratory. Participants with an unknown or missing response or who discontinued prior to week 49, week 97 or week 169 for any reason were treated as non-responders.

    Measured: Baseline and Weeks 49, 97 and 169

  16. Percentage of Participants With a 90% or Greater Reduction From Baseline in PSA Level

    Participants with unknown or missing PSA results at week 25 or who discontinued prior to week 25 were considered non-responders at week 25. Participants with unknown or missing PSA results at week 49, week 97 or week 169 were considered non-responders.

    Measured: Baseline and Weeks 25, 49, 97 and 169

  17. Percentage of Participants With PSA ≤ 4 ng/ml

    Participants with unknown or missing PSA results at week 25 or who discontinued prior to Week 25 were considered non-responders at Week 25. Participants with unknown or missing PSA results at week 49, 97 and 169 were considered non-responders.

    Measured: Weeks 25, 49, 97 and 169

  18. Percentage of Participants With PSA ≤ 0.1 ng/ml

    Participants with unknown or missing PSA results at week 25 or who discontinued prior to week 25 were considered non-responders at week 25. Participants with unknown or missing PSA results at week 49, 97 or 169 were considered non-responders.

    Measured: Weeks 25, 49, 97 and 169

  19. Maximum Decline From Baseline in PSA

    The maximum decline from Baseline in PSA was calculated as the largest reduction from Baseline in PSA level that occurred at any point after treatment start up to week 25 and up to and including the assessment made at the safety follow-up visit, divided by the PSA Baseline value and multiplied by 100, i.e., the maximum percent change from baseline.

    Measured: Baseline to Week 25 and from Baseline up to the EOS date of 27 Apr 2017; median duration of treatment of 1666.0 days (range of 52-2052)

  20. Time to PSA Response

    Time to PSA response (PSA decline ≥ 80% from Baseline) is defined as the time interval from the first study drug dose to the first date a decline from Baseline in PSA level of 80% or greater was recorded. Time to response was estimated using the Kaplan-Meier method.

    Measured: From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)

  21. Time to PSA Decline ≥ 90%

    Time to PSA decline ≥ 90% is defined as the time interval from the first study drug dose to the first date a decline from Baseline in PSA level of 90% or greater was recorded. Time to PSA decline ≥ 90% was estimated using the Kaplan-Meier method.

    Measured: From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)

  22. Time to PSA ≤ 4 ng/ml

    Time to PSA ≤ 4 ng/ml is defined as the time interval from the first study drug dose to the first date a decline in PSA to a result of 4 ng/ml or below was recorded. Time to PSA ≤ 4 ng/ml was estimated using the Kaplan-Meier method.

    Measured: From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)

  23. Time to PSA ≤ 0.1 ng/ml

    Time to PSA ≤ 0.1 ng/ml is defined as the time interval from the first study drug dose to the first date a decline in PSA to a result of 0.1 ng/ml or below was recorded.

    Time to PSA ≤ 0.1 ng/ml was estimated using the Kaplan-Meier method.

    Measured: From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)

  24. Time to PSA Progression

    Time to PSA progression is defined as the time interval from the first study drug dose to the first date of PSA progression. PSA progression is defined as a ≥ 25% increase in PSA with an absolute increase of ≥ 2 ng/mL above the nadir unless the PSA next measurement(s), if available, does not confirm the PSA progression.

    Measured: From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)

  25. PSA Doubling Time

    PSA doubling time was to be calculated from the slope estimated from a linear regression of the natural log of PSA fitted on time, if the slope was positive. Since the slope was negative for all participants, PSA doubling time could not be calculated.

    Measured: From Baseline to Week 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2011 (estimated)
  2. Study start6 May 2011
  3. Primary completion29 Jul 2012
  4. Study completion27 Apr 2017

Resources

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
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01302041
Sponsor's protocol ID
9785-CL-0321
Other IDs
2010-021287-16
Status last verified
May 2018
First submitted
21 Feb 2011
Last updated
2 Oct 2018
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Trump D. Commentary on: "Enzalutamide monotherapy in hormone-naive prostate cancer: primary analysis of an open-label, single-arm, phase 2 study." Tombal B, Borre M, Rathenborg P, Werbrouck P, Van Poppel H, Heidenreich A, Iversen P, Braeckman J, Heracek J, Baskin-Bey E, Ouatas T, Perabo F, Phung D, Hirmand M, Smith MR. Institut de Recherche Clinique, Universite Catholique de Louvain, Brussels, Belgium. Electronic address: bertrand.tombal@uclouvain.be. Aarhus University Hospital, Aarhus, Denmark. Herlev Hospital, Herlev, Denmark. AZ Groeninge Kortrijk, Kortrijk, Belgium. UZ Leuven, Leuven, Belgium. Klinik und Poliklinik fur Urologie, RWTH University Aachen, Aachen, Germany. Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. UZ Brussel, Brussels, Belgium. Univerzita Karlova v Praze, Prague, Czech Republic. Astellas Pharma Global Development, Leiden, Netherlands. Astellas Pharma Global Development, Northbrook, IL, USA. Medivation Inc, San Francisco, CA, USA. Massachusetts General Hospital Cancer Center, Boston, MA, USA: Lancet Oncol. 2014 May;15(6):592-600; doi: 10.1016/S1470-2045(14)70129-9. [Epub 2014 Apr 14]. Urol Oncol. 2016 May;34(5):248-9. doi: 10.1016/j.urolonc.2015.03.012. Epub 2015 Apr 30.

    PubMed 25937426

  • Tombal B, Borre M, Rathenborg P, Werbrouck P, Van Poppel H, Heidenreich A, Iversen P, Braeckman J, Heracek J, Baskin-Bey E, Ouatas T, Perabo F, Phung D, Baron B, Hirmand M, Smith MR. Long-term Efficacy and Safety of Enzalutamide Monotherapy in Hormone-naive Prostate Cancer: 1- and 2-Year Open-label Follow-up Results. Eur Urol. 2015 Nov;68(5):787-94. doi: 10.1016/j.eururo.2015.01.027. Epub 2015 Feb 14.

    PubMed 25687533

  • Tombal B, Borre M, Rathenborg P, Werbrouck P, Van Poppel H, Heidenreich A, Iversen P, Braeckman J, Heracek J, Baskin-Bey E, Ouatas T, Perabo F, Phung D, Hirmand M, Smith MR. Enzalutamide monotherapy in hormone-naive prostate cancer: primary analysis of an open-label, single-arm, phase 2 study. Lancet Oncol. 2014 May;15(6):592-600. doi: 10.1016/S1470-2045(14)70129-9. Epub 2014 Apr 14.

    PubMed 24739897

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enzalutamide in people with Prostate Cancer, run by Astellas Pharma Inc at 12 sites in 4 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 4 inclusion and 9 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 2 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 12 sites in Belgium, Denmark, Germany, Czechia. 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 6 Apr 2016). 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?

Percentage of Participants With a Prostate-Specific Antigen (PSA) Response at Week 25 (time frame: Baseline and Week 25). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01302041, which also lists 3 linked publications.

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 2 Oct 2018.

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