Clinical Trial: NCT03827473 - My Cancer Genome

NCT03827473

Description:

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.

Related Conditions:

Prostate Adenocarcinoma

Recruiting Status:

Terminated

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT03827473

Trial Eligibility

Document

Title

Brief Title: Docetaxel or Abiraterone Acetate With ADT in Treating Patients With Metastatic Hormone Sensitive Prostate Cancer
Official Title: ACADEMIC: A Randomized Phase II Clinical Trial of ADT Combined With Abiraterone or Docetaxel in Metastatic Hormone Sensitive Prostate Cancer

Clinical Trial IDs

ORG STUDY ID: HCI115099
NCT ID: NCT03827473

Conditions

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

Interventions

Drug	Synonyms	Arms
Abiraterone Acetate	CB7630, Zytiga	Arm B (ADT, abiraterone acetate, prednisone)
Antiandrogen Therapy	ADT, Androgen Deprivation Therapy, Anti-androgen Therapy, Anti-androgen Treatment, Antiandrogen Treatment, Hormone Deprivation Therapy, Hormone-Deprivation Therapy	Arm A (ADT, docetaxel)
Docetaxel	Docecad, RP56976, Taxotere, Taxotere Injection Concentrate	Arm A (ADT, docetaxel)
Prednisone	.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)

Purpose

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.

Trial Arms

Name	Type	Description	Interventions
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.	Antiandrogen Therapy Docetaxel
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.	Abiraterone Acetate Antiandrogen Therapy Prednisone

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).

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	Male
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Change in Quality of Life - FACT-P
Time Frame:	Planned for up to one year, but actual was 3 months
Safety Issue:
Description:	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.

Secondary Outcome Measures

Measure:	Prostate-specific Antigen (PSA) Response
Time Frame:	Planned for up to 18 months, but actual was 3 months
Safety Issue:
Description:	PSA evaluations will occur every 3 months while on study. PSA response is defined as a reduction in PSA value of greater than or equal to 90% from baseline, reported as a count of participants who had a PSA response on the study.

Measure:	Change in Quality of Life - FACT/GOG-NTX
Time Frame:	Planned for up to 18 months, but actual was 3 months
Safety Issue:
Description:	Quality of Life questionnaires will be done every 3 months while participants are on treatment. The scale used will be the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) (FACT/GOG-NTX) scale (version 4). FACT/GOG-NTX total score ranges from 0 to 152, with higher scores indicating a higher quality of life.

Measure:	Change in Quality of Life - PROMIS Fatigue
Time Frame:	Planned for up to 18 months, but actual was 3 months
Safety Issue:
Description:	Quality of Life questionnaires will be done every 3 months while participants are on treatment. The scale used will be the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scale. Total raw scores range from 7 to 35, with higher scores indicating a higher level of fatigue.

Measure:	Prostate Specific Antigen Progression Free Survival (PSA-PFS)
Time Frame:	Planned up to 18 months, but actual was 3 months
Safety Issue:
Description:	Prostate Specific Antigen (PSA) will be measured every three months while on study. PSA Progression Free Survival (PSA-PSF) will be reported as the number of participants who have not demonstrated PSA progression by the end of the follow-up period. PSA progression is defined by meeting the following criteria: 1) an increase in PSA of greater than or equal to 25% from baseline or nadir, AND 2) an increase in PSA of at least 2 ng/dL, AND 3) the increase is confirmed at least 3 weeks later. This analysis was planned for up to 18 months following study enrollment, but the only participant enrolled on the study was only followed for 3 months.

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Terminated
Lead Sponsor:	University of Utah

Last Updated

June 25, 2020

Clinical Trials /

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