Study of MDV3100 as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Astellas Pharma Inc

Information provided by (Responsible Party):

Medivation, Inc.

ClinicalTrials.gov Identifier:

NCT01547299

First received: February 27, 2012

Last updated: March 12, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	February 27, 2012
Last Updated Date	March 12, 2013
Start Date ^ICMJE	March 2012
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 2, 2012)	Pathological Complete Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ] To assess the pathological complete response rate following triplet therapy (MDV3100 in combination with leuprolide and dutasteride) and MDV3100 alone when administered as neoadjuvant therapy for 6 months prior to prostatectomy in patients with localized prostate cancer
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01547299 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 2, 2012)	PSA [ Time Frame: 6 Months ] [ Designated as safety issue: No ] To determine the effects on prostate-specific antigen (PSA) (including median nadir value, percentage of patients achieving PSA < 0.2 ng/mL, the proportion of patients achieving 50% and 90% decrease in PSA, and time to PSA nadir) for triplet therapy and MDV3100 alone Determine the rate of positive surgical margins [ Time Frame: 6 months ] [ Designated as safety issue: No ] To determine the rate of positive surgical margins, extracapsular extension, positive seminal vesicles and lymph nodes at the time of prostatectomy for triplet therapy and MDV3100 alone. Pharmacodynamics [ Time Frame: 6 months ] [ Designated as safety issue: No ] To determine the effects of triplet therapy and MDV3100 alone on selected pharmacodynamic markers on prostatectomy specimens including apoptosis, mitotic index, androgen receptor signaling, and others. Determine effects on testosterone and dihydrotestosterone (DHT) [ Time Frame: 6 months ] [ Designated as safety issue: No ] To determine the effects on testosterone and dihydrotestosterone (DHT) (including median values of testosterone and DHT during and at completion of therapy) for triplet therapy and MDV3100 alone Assess the safety and tolerability of triplet therapy and MDV3100 alone [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] To assess the safety and tolerability of triplet therapy and MDV3100 alone in the neoadjuvant setting. Safety and tolerability will be documented throughout the study by assessment of adverse events, vital signs, electrocardiograms (ECGs), and laboratory assessments
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of MDV3100 as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer
Official Title ^ICMJE	A Randomized, Open-Label, Phase 2 Study of MDV3100 as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer
Brief Summary	The purpose of this study is to determine if MDV3100 is an effective therapy in treating localized prostate cancer prior to prostatectomy.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Prostate Cancer
Intervention ^ICMJE	Drug: MDV3100 MDV3100 160 mg, orally, once daily Drug: MDV3100 + Leuprolide + Dutasteride MDV3100 160 mg, orally, once daily in combination with leuprolide 22.5 mg, IM, Q 3 Months and dutasteride, 0.5 mg, PO, QD
Study Arm (s)	Experimental: MDV3100 MDV3100 alone Intervention: Drug: MDV3100 Experimental: MDV3100 + Leuprolide + Dutasteride MDV3100 in combination with leuprolide and dutasteride Intervention: Drug: MDV3100 + Leuprolide + Dutasteride
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	50
Estimated Completion Date	August 2013
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Willing to provide informed consent 18 years of age or older Histologically confirmed adenocarcinoma of the prostate Must be a candidate for radical prostatectomy and considered surgically resectable Exclusion Criteria: Stage T4 prostate cancer by clinical or radiologic evaluation Treatment with an investigational agent within 4 weeks prior to randomization Received therapy for for other neoplastic disorders within 5 years Hypogonadism or severe androgen deficiency
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT Number ^ICMJE	NCT01547299
Other Study ID Numbers ^ICMJE	MDV3100-07
Has Data Monitoring Committee	No
Responsible Party	Medivation, Inc.
Study Sponsor ^ICMJE	Medivation, Inc.
Collaborators ^ICMJE	Astellas Pharma Inc
Investigators ^ICMJE	Not Provided
Information Provided By	Medivation, Inc.
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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