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Genital Diseases, Male

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Male Urogenital Diseases

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Docetaxel

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Docetaxel + Enzalutamide + Androgen Deprivation Therapy

ADT+Docetaxel+Enzalutamide

Earle Burgess, MD

This is a study with the combination of androgen deprivation therapy (ADT) and docetaxel with the addition of enzalutamide in the treatment of subjects with metastatic prostate cancer. The purpose of this study is to assess if ADT + docetaxel + enzalutamide is well tolerated and demonstrates improved efficacy compared to ADT + docetaxel.

This is a single center, single arm, phase II trial designed to evaluate the 12 month PSA complete response rate in patients with metastatic hormone sensitive prostate cancer treated with ADT, docetaxel and enzalutamide. The primary endpoint of this study will be 12-month PSA complete response rate, which will be assessed against a contemporary historical control rate for the combination of ADT and docetaxel alone in the metastatic hormone naive setting. The study will be conducted at all participating sites across North and South Carolina within the Levine Cancer Institute network. Enrollment is anticipated to be completed within 24 months.

A Trial of Androgen Deprivation, Docetaxel, and Enzalutamide for Metastatic Prostate Cancer

A Phase II Trial of Androgen Deprivation, Docetaxel and Enzalutamide in Patients With Metastatic Hormone Sensitive Prostate Cancer

The 52-week PSA CR rate was defined as the proportion of participants achieving PSA complete response (CR) at 52-weeks (+/- 1 week) from date of enrollment (i.e., initiation of both enzalutamide and docetaxel) of all evaluable participants. PSA CR was defined as PSA level less than 0.2 ng/ml for two consecutive measurements at least three weeks apart (date of initial PSA level 0.2 ng/ml was acknowledged as date of response). In subjects with missed PSA assessments at 52 (+/- 1) weeks, (a) if a confirmed CR was achieved and at least one PSA assessment occurred beyond the 52-week window showed serologic complete response (providing the subject did not earlier experience confirmed progressive disease), the subject achieved 52-week PSA Complete Response and (b) if confirmed CR was achieved before the 52-week window and the first assessment after the 52-week window was not a CR, the subject did not achieve a 52-week PSA Complete Response.

Astellas Pharma Inc

Medivation, Inc.

Wake Forest University Health Sciences

Treatment-emergent adverse events were reported and defined as an adverse event that occurred after treatment start that was not present at the time of treatment start or an adverse event that increased in severity after treatment start if the event was present at the time of treatment start.

Docetaxel + Enzalutamide + Androgen Deprivation Therapy

ADT+Docetaxel+Enzalutamide: combination therapy as listed above

Single Arm

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Disease volume at enrollment

All enrolled patients (i.e., patients initiating enzalutamide and docetaxel)

Danielle Boselli

The 12-month PSA CR rate with ADT + docetaxel is 27.7% (Sweeney 2015); we estimated that the lower limit of the 95% CI was 23.4%. We sought to test the null hypothesis that the 52-week PSA CR rate for subjects treated with study therapy was \<=25%. We anticipated enrolling 39 subjects and this design would provide 90% power with a 1-sided alpha =0.10 significance level, assuming the true 52-week PSA CR rate was 45%. An improvement from 25% to 45% in 52-week PSA CR rate was considered important.

The evaluable population for the primary analysis included subjects who began study treatment and did not discontinue enzalutamide prior to the development of castrate resistance for reasons other than can be attributed to study treatment. Four enrolled subjects were not evaluable for the analysis of the primary objective for reasons including consent withdrawal and noncompliance.

Spots Global Cancer Trial Database for adt+docetaxel+enzalutamide