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Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer

A Phase II Randomized Prospective Trial of Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer (CRPC) Patients Progressing on Enzalutamide

NCT02685267•Prostate Cancer Clinical Trials Consortium

View on ClinicalTrials.gov

Summary

This is a prospective randomized phase II clinical trial where patients who are receiving enzalutamide in the pre-chemotherapy space are randomized upon objective progression (radiographic and/or clinical per PCWG2 criteria) to docetaxel/prednisone alone or the same combination plus enzalutamide. The primary aim is to evaluate whether continuing enzalutamide in combination with docetaxel in patients who failed or progressed while on enzalutamide would increase progression-free survival (PFS) by 4 months. The secondary end points are PSA responses, percent of patients alive at 1 and 2 years, decline in circulating tumor cells (CTCs), and quality of life (QOL) using validated scales.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.
•NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
•Males 18 years of age and above
•Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
•Having documented disease progression on enzalutamide defined by 1 or more of the following criteria:
•PSA progression according to PCWG2 criteria with 3 consecutive rising PSA measurements, all collected at least 1 week apart
•Radiographic progression in soft tissue or bone by modified RECIST 1.1 for subjects with measurable disease; or
•Bone disease progression defined by 2 or more new lesions on 2 consecutive bone scans in the absence of falling PSA
•Patients who have not had a bilateral orchiectomy must have a plan to maintain effective GnRG-analogue therapy for the duration of the trial
•Serum testosterone level \< 50 ng/dL at Screening visit
+19 more criteria

Exclusion Criteria

•Prior treatment with docetaxel-based chemotherapy
•Prior treatment with abiraterone acetate
•Prior treatment with cabazitaxel
•Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
•Ongoing investigational treatment
•Medical conditions such as uncontrolled hypertension, uncontrolled diabetes mellitus, cardiac disease that would, in the opinion of the investigator, make this protocol unreasonably hazardous
•Major surgery within 4 weeks of enrollment
•Use of an investigational therapeutic agent with 4 weeks of enrollment
•History of seizure or any condition that may predispose to seizure.
•History of loss of consciousness or transient ischemic attack within 12 months of enrollment
+5 more criteria

Locations (5)

The University of Chicago

Chicago, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

NorthShore University HealthSytem - Kellogg Cancer Center

Evanston, Illinois, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Univesity of Wisconsin

Madison, Wisconsin, United States

Key Dates

Start Date

February 1, 2016

Primary Completion Date

August 1, 2017

Completion Date

August 1, 2017

Last Updated

April 9, 2021

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Docetaxel

DRUG

Enzalutamide

DRUG

Prednisone

DRUG

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

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RECRUITINGPHASE2

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Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 9, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC