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

NCT03246347 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB00081385LCI-GU-PRO-ADDE-001Pro00018087
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 52-week PSA Complete Response (CR) Rate

  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.

  52 weeks

Secondary Outcomes (8)

• Serologic Response Rate

  Duration of study participation, an average of 2 years

• Radiographic Response Rate

  Duration of study participation, an average of 2-3 years

• Time to Castrate Resistance

  Duration of study participation, an average of 2 years

• Serologic Progression Free Survival

  Duration of study participation, an average of 2 years

• Radiographic Progression Free Survival

  Duration of study participation, an average of 2-3 years

Study Arms (1)

Single Arm

EXPERIMENTAL

Docetaxel + Enzalutamide + Androgen Deprivation Therapy

Drug: ADT+Docetaxel+Enzalutamide

Interventions

ADT+Docetaxel+Enzalutamide DRUG

combination therapy as listed above

Also known as: Taxotere, Xtandi

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the prostate without evidence of small cell carcinoma or greater than 50% neuroendocrine differentiation. Metastatic disease must be present including soft tissue, and/or bone metastases OR nonregional lymph node involvement prior to study enrollment. If the subject has regional lymph node involvement, there must be at least one additional site of disease including visceral, non-regional nodal or skeletal metastases.
• ADT with surgical castration with bilateral orchiectomy or medical castration with LHRH agonist or LHRH antagonist therapy may have been initiated no greater than 112 days (16 weeks) prior to enrollment date. Subjects who initiated ADT prior to consent, are not eligible if PSA has risen ≥ 25% and ≥ 2 ng/ml above nadir value since initiation of ADT prior to consent.
• At least one PSA level of ≥ 5 ng/ml within 90 days prior to consent.
• Prior ADT for non-metastatic disease with LHRH agonist or LHRH antagonist therapy in the neoadjuvant/adjuvant setting is permitted if:
• Total duration of therapy did not exceed 36 months
• months have elapsed since completion of therapy prior to consent,
• Serum testosterone \> 50 ng/dl within 28 days prior to reinitiation of ADT for metastatic disease
• Prior ADT for non-metastatic disease must have accompanied definitive local therapy for curative intent.
• Age ≥ 18 years.
• ECOG performance status 0-2.
• Adequate liver function: AST and ALT \<1.5x upper limit of normal, total bilirubin \< 1x upper limit of normal.
• Adequate bone marrow function: Platelets \>100,000 cells/mm3, Hemoglobin \> 8.0g/dL and ANC \> 1,500 cells/mm3.
• Adequate renal function with a creatinine clearance (based on Cockcroft-Gault formula) ≥ 30 mL/min.
• Ability to understand and the willingness to sign a written informed consent document.
• Able to swallow and retain oral medication

You may not qualify if:

• Personal history of seizure.
• Personal history of conditions that may predispose to seizure activity including cortical cerebrovascular accident or brain trauma.
• Known central nervous system metastases, including involvement of brain parenchyma and leptomeninges.
• Personal history of any condition that may impair absorption of enzalutamide.
• Prior or current therapy with ketoconazole, abiraterone, enzalutamide, apalutamide (ARN-509, JNJ-56021927), darolutamide (ODM-201, BAY1841788) or cytotoxic chemotherapy such as docetaxel, cabazitaxel, cyclophosphamide.
• Prior therapy with bicalutamide, nilutamide or flutamide within 14 days of enrollment.
• Within 28 days of major surgery and/or lack of recovery from prior surgical procedure or 14 days of palliative radiation prior to enrollment.
• Prior or current therapy with an investigational agent for metastatic prostate cancer.
• Known hypersensitivity to drugs formulated with polysorbate 80.
• Personal history of posterior reversible encephalopathy syndrome.
• CTCAE version 4.0 grade 2-4 peripheral sensory neuropathy.
• Human immunodeficiency virus infection or active hepatitis B or C infection.
• Uncontrolled and current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the investigator.
• Presence of any of the following within the previous 3 months prior to enrollment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.
• History of an additional active malignancy within 12 months prior to the date of consent (except non-melanoma skin cancer).

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Astellas Pharma Inc: collaborator
• Medivation, Inc.: collaborator

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; enzalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Danielle Boselli
• Organization: Wake Forest

danielle.boselli@atriumhealth.edu

2017903385

Study Officials

• Earle Burgess, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 11, 2017
• Study Start: August 23, 2017
• Primary Completion: September 1, 2022
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 23, 2026
• Results First Posted: September 22, 2023

Record last verified: 2026-01

Locations

US (1)