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

NCT03827473 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: HCI115099
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life - FACT-P

  The impact of abiraterone acetate and docetaxel on health related quality of life will be assessed every 3 months from screening to month 12 of treatment or follow-up. The scale used will be the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale. The total score ranges from 0 to 156, with higher scores indicating a higher quality of life. The primary endpoint was intended to be quality of life at 12 months, but since no participants completed 12 months of treatment/follow-up, scores at baseline and 3 months are reported instead.

  Planned for up to one year, but actual was 3 months

Secondary Outcomes (4)

• Prostate-specific Antigen (PSA) Response

  Planned for up to 18 months, but actual was 3 months

• Change in Quality of Life - FACT/GOG-NTX

  Planned for up to 18 months, but actual was 3 months

• Change in Quality of Life - PROMIS Fatigue

  Planned for up to 18 months, but actual was 3 months

• Prostate Specific Antigen Progression Free Survival (PSA-PFS)

  Planned up to 18 months, but actual was 3 months

Study Arms (2)

Arm A (ADT, docetaxel)

EXPERIMENTAL

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.

Drug: Antiandrogen Therapy; Drug: Docetaxel; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm B (ADT, abiraterone acetate, prednisone)

EXPERIMENTAL

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.

Drug: Abiraterone Acetate; Drug: Antiandrogen Therapy; Drug: Prednisone; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Abiraterone Acetate DRUG

Given PO

Also known as: CB7630, Zytiga

Arm B (ADT, abiraterone acetate, prednisone)

Antiandrogen Therapy DRUG

Given per standard of care

Also known as: ADT, Androgen Deprivation Therapy, Anti-androgen Therapy, Anti-androgen Treatment, Antiandrogen Treatment, Hormone Deprivation Therapy, Hormone-Deprivation Therapy

Arm A (ADT, docetaxel); Arm B (ADT, abiraterone acetate, prednisone)

Docetaxel DRUG

Given IV

Also known as: Docecad, RP56976, Taxotere, Taxotere Injection Concentrate

Arm A (ADT, docetaxel)

Prednisone DRUG

Given PO

Also known as: .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

Arm B (ADT, abiraterone acetate, prednisone)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (ADT, docetaxel); Arm B (ADT, abiraterone acetate, prednisone)

Questionnaire Administration OTHER

Ancillary studies

Arm A (ADT, docetaxel); Arm B (ADT, abiraterone acetate, prednisone)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; Androgen Antagonists; Docetaxel; Prednisone; deltacortene; prednylidene

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)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienediols; Pregnadienes; Pregnanes

Results Point of Contact

• Title: Data Manager
• Organization: Huntsman Cancer Institute Research Compliance Office

compliance@hci.utah.edu

8015850601

Study Officials

• Benjamin Maughan, MD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 1, 2019
• Study Start: February 8, 2019
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: June 25, 2020
• Results First Posted: June 25, 2020

Record last verified: 2020-06

Locations

US (1)