Docetaxel or Abiraterone Acetate With ADT in Treating Patients With Metastatic Hormone Sensitive Prostate Cancer

NCT ID: NCT03827473

Last Updated: 2020-06-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-08
• Study Completion Date: 2019-07-31

Brief Summary

This phase II trial studies how well docetaxel or abiraterone acetate work when combined with androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as docetaxel and abiraterone acetate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Antihormone therapy, such as ADT may lessen the amount of androgen made by the body. It is not yet known whether docetaxel or abiraterone acetate work better when combined with ADT in treating patients with hormone sensitive prostate cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To assess the impact of abiraterone acetate (abiraterone) and docetaxel on total quality of life between screening and month 12 of the study.

SECONDARY OBJECTIVES:

I. To assess prostate specific androgen (PSA) response rates across the entire population and compared between groups.

II. To assess impact of abiraterone and docetaxel on additional quality of life measurements and quality of life trends throughout the duration of the study.

III. To assess the potential clinical efficacy between treatment groups.

Conditions

Castration-Sensitive Prostate Carcinoma; Metastatic Prostatic Adenocarcinoma; Stage IV Prostate Cancer; Stage IVA Prostate Cancer; Stage IVB Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A (ADT, docetaxel)

Participants receive androgen deprivation therapy (ADT) per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Antiandrogen Therapy

Intervention Type: DRUG

Given per standard of care

Docetaxel

Intervention Type: DRUG

Given IV

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Arm B (ADT, abiraterone acetate, prednisone)

Participants receive androgen deprivation therapy (ADT) per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Abiraterone Acetate

Intervention Type: DRUG

Given PO

Antiandrogen Therapy

Intervention Type: DRUG

Given per standard of care

Prednisone

Intervention Type: DRUG

Given PO

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Abiraterone Acetate

Given PO

Intervention Type: DRUG

Antiandrogen Therapy

Given per standard of care

Intervention Type: DRUG

Docetaxel

Given IV

Intervention Type: DRUG

Prednisone

Given PO

Intervention Type: DRUG

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

CB7630; Zytiga; ADT; Androgen Deprivation Therapy; Anti-androgen Therapy; Anti-androgen Treatment; Antiandrogen Treatment; Hormone Deprivation Therapy; Hormone-Deprivation Therapy; Docecad; RP56976; Taxotere; Taxotere Injection Concentrate; .delta.1-Cortisone; 1, 2-Dehydrocortisone; Adasone; Cortancyl; Dacortin; DeCortin; Decortisyl; Decorton; Delta 1-Cortisone; Delta-Dome; Deltacortene; Deltacortisone; Deltadehydrocortisone; Deltasone; Deltison; Deltra; Econosone; Lisacort; Meprosona-F; Metacortandracin; Meticorten; Ofisolona; Orasone; Panafcort; Panasol-S; Paracort; PRED; Predicor; Predicorten; Prednicen-M; Prednicort; Prednidib; Prednilonga; Predniment; Prednisonum; Prednitone; Promifen; Servisone; SK-Prednisone; Quality of Life Assessment

Eligibility Criteria

Inclusion Criteria

• Histologically diagnosed adenocarcinoma of the prostate.
• Radiographically confirmed metastatic disease prior to patient enrollment. Metastatic disease can be confirmed based on conventional imaging (CT, MRI, nuclear medicine bone scan) or molecular imaging (fluciclovine-positron emission tomography (PET)/CT, prostate-specific membrane antigen (PSMA)-PET/CT, Choline-PET/CT etc).
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2.
• Absolute neutrophil count (ANC) >= 1.5 k/uL.
• Platelets >= 100 k/uL.
• Hemoglobin >= 9 g/dL.
• Serum total bilirubin =< 1.5 times upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin >= 1.5 x ULN.
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x ULN OR =< 4 x ULN for subjects with liver metastases.
• Creatinine < 1.5 x ULN OR
• Creatinine clearance > 50 mL/min for subject with creatinine levels > 1.5 x ULN by Cockcroft-Gault formula or standard institutional practice.
• Highly effective method of contraception for both male and female partners of subjects throughout the study and for at least 3 months after last study treatment administration if the risk of conception exists.
• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
• Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 from toxicities related to any prior treatments, unless adverse event (AE)(s) are clinically nonsignificant and/or stable on supportive therapy as defined by the treating physician.

Exclusion Criteria

• No prior abiraterone or docetaxel therapy for metastatic hormone sensitive prostate cancer. Prior therapy with ADT or first generation anti-androgen receptor therapy (example: bicalutamide) is allowed.
• Completed any hormone therapy for localized prostate cancer and have recovery of testosterone (i.e. testosterone level is >50ng/dL).
• Patients have a histologic diagnosis of small cell prostate cancer or pure squamous cell prostate cancer.
• Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.
• The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:

• Cardiovascular disorders:

• Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias within 3 months of study enrollment.
• Uncontrolled hypertension defined as sustained blood pressure (BP) > 170 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment.
• Stroke (including transient ischemic attack (TIA)), myocardial infarction (MI), or other ischemic event, or arterial thromboembolic event within 3 months before first dose.
• Other clinically significant disorders that would preclude safe study participation. As defined by the treating physician.
• Known history of testing positive for human immunodeficiency virus (HIV) and cluster of differentiation 4 (CD4) count is below 200 or known acquired immunodeficiency syndrome diagnosis.
• Known history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or detectable HCV ribonucleic acid [RNA] if anti-HCV antibody screening test positive) and a detectable viral count at screening.
• Use of live virus vaccine within 4 weeks of the first dose of treatment or planned use while on trial for the duration of potential docetaxel treatment. Live vaccine use is acceptable after chemotherapy or for patients randomized to the abiraterone arm. There are no restrictions on inactive viruses.
• Known prior severe hypersensitivity to investigational product or any component in its formulations (National Cancer Institute [NCI] CTCAE v5.0 grade >= 3).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Maughan, MD

Role: PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute/ University of Utah

Locations

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HCI115099

Identifier Type: -

Identifier Source: org_study_id