Clinical trial NCT01302041: A Study to Test if Enzalutamide is Effective and Safe in Prostate Cancer Patients Who Have Never Had Hormone Therapy
Official title: A Phase 2, Open-label, Single-arm, Efficacy and Safety Study of Enzalutamide (MDV3100) in Patients With Hormone-naïve Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: bone turnover
hormone-naïve
prostate specific antigen
Prostate Cancer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Medivation, Inc.
First posted: 2011-02-23
Enrollment: 67
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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
* 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

Primary outcomes:
measure: Percentage of Participants With a Prostate-Specific Antigen (PSA) Response at Week 25
timeFrame: Baseline and Week 25
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 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)
measure: Percent Change From Baseline in PSA
timeFrame: Baseline and Weeks 25, 49, 97, 169 and Week 265 (End of Study)
measure: Percent Change From Baseline in Sex Hormone-Binding Globulin (SHBG)
timeFrame: Baseline and Weeks 25 and 49
measure: Percent Change From Baseline in Androstenedione
timeFrame: Baseline and Weeks 25 and 49
measure: Percent Change From Baseline in Dehydroepiandrosterone (DHEA)
timeFrame: Baseline and Weeks 25 and 49
measure: Percent Change From Baseline in Dihydrotestosterone (DHT)
timeFrame: Baseline and Week 25 and 49
measure: Percent Change From Baseline in Estradiol
timeFrame: Baseline and Weeks 25 and 49
measure: Percent Change From Baseline in Follicle-Stimulating Hormone (FSH)
timeFrame: Baseline and Weeks 25 and 49
measure: Percent Change From Baseline in Luteinizing Hormone (LH)
timeFrame: Baseline and Weeks 25 and 49
measure: Percent Change From Baseline in Prolactin
timeFrame: Baseline and Weeks 25 and 49
measure: Percent Change From Baseline in Total Testosterone
timeFrame: Baseline and Weeks 25 and 49
measure: Percent Change From Baseline in Free Testosterone
timeFrame: Baseline and Weeks 25 and 49
measure: Plasma Concentration of Enzalutamide at Pre-dose (Ctrough)
timeFrame: Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25
measure: Plasma Concentration of Enzalutamide Metabolite M2 at Pre-dose (Ctrough)
timeFrame: Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25
measure: Percentage of Participants With a PSA Response at Weeks 49, 97 and 169
timeFrame: Baseline and Weeks 49, 97 and 169
measure: Percentage of Participants With a 90% or Greater Reduction From Baseline in PSA Level
timeFrame: Baseline and Weeks 25, 49, 97 and 169
measure: Percentage of Participants With PSA ≤ 4 ng/ml
timeFrame: Weeks 25, 49, 97 and 169
measure: Percentage of Participants With PSA ≤ 0.1 ng/ml
timeFrame: Weeks 25, 49, 97 and 169
measure: Maximum Decline From Baseline in PSA
timeFrame: 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)
measure: Time to PSA Response
timeFrame: From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)
measure: Time to PSA Decline ≥ 90%
timeFrame: From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)
measure: Time to PSA ≤ 4 ng/ml
timeFrame: From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)
measure: Time to PSA ≤ 0.1 ng/ml
timeFrame: From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)
measure: Time to PSA Progression
timeFrame: From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)
measure: PSA Doubling Time
timeFrame: From Baseline to Week 25
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Site BE1003
city: Brussels
country: Belgium
facility: Site BE1001
city: Kortrijk
country: Belgium
facility: Site BE1002
city: Leuven
country: Belgium
facility: Site BE1005
city: Olomouc
country: Czechia
facility: Site CZ3006
city: Praha 6
country: Czechia
facility: Site CZ3002
city: Aarhus N
country: Denmark
facility: Site DK4001
city: Copenhagen
country: Denmark
facility: Site DK4004
city: Herlev
country: Denmark
facility: Site DK4002
city: Aachen
country: Germany
facility: Site DE5005
city: Bonn
country: Germany
facility: Site DE5007
city: Hannover
country: Germany
facility: Site DE5003
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.