Clinical Trials /

Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity and Other Factors in Metastatic Hormone Naive Prostate Cancer

NCT03833921

Description:

The investigators are conducting this study with men that have prostate cancer and are getting standard of care treatment with the drugs abiraterone acetate and prednisone. The study will follow men with prostate cancer from initiation of participation in the study and for up to 10 years. The reason for the study is that researchers think that there may be a connection between the race and ethnicity of men with prostate cancer and how well the standard treatments work for the participants.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity and Other Factors in Metastatic Hormone Naive Prostate Cancer
  • Official Title: Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity, PSA Decline and Genetic Variation in Proteins Involved in Androgen Metabolism in Metastatic Hormone Naive Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: H-44335
  • NCT ID: NCT03833921

Conditions

  • Prostate Cancer Metastatic
  • Prostate Cancer

Interventions

DrugSynonymsArms
Abiraterone AcetateZytigaAbiraterone acetate + prednisone
PrednisoneAbiraterone acetate + prednisone

Purpose

The investigators are conducting this study with men that have prostate cancer and are getting standard of care treatment with the drugs abiraterone acetate and prednisone. The study will follow men with prostate cancer from initiation of participation in the study and for up to 10 years. The reason for the study is that researchers think that there may be a connection between the race and ethnicity of men with prostate cancer and how well the standard treatments work for the participants.

Detailed Description

      This is a single arm study in metastatic hormone naïve prostate cancer. Standard of care in
      these men is either to offer Androgen deprivation therapy (ADT) + abiraterone
      acetate/low-dose prednisone or, in men with higher tumor burden, to offer ADT +
      Docetaxel/prednisone. The investigator's experience is that even men with increased tumor
      burden often opt for abiraterone because of the improved side effect protocol as compared to
      chemotherapy.

      Approximately 130 PSA response evaluable subjects will be enrolled, of which the
      investigators expect 50% to be African American based on clinic population and previous
      experience with clinical trial enrollment.

      The study will enroll men with newly diagnosed hormone naïve prostate cancer within 42 days
      of receiving the first dose of ADT (LHRH agonist) or undergoing orchiectomy. Patients will
      continue ADT throughout the study. Abiraterone acetate and low dose prednisone will continue
      until progression as defined by standard PCWG2 criteria.
    

Trial Arms

NameTypeDescriptionInterventions
Abiraterone acetate + prednisoneOtherAll subjects will receive abiraterone acetate and prednisone, as per standard of care. Abiraterone acetate will be administered orally as 1000 mg once daily along with 5 mg of oral prednisone twice per day. Subjects will continue to take abiraterone acetate and prednisone until confirmed disease progression.
  • Abiraterone Acetate
  • Prednisone

Eligibility Criteria

        Inclusion Criteria:

          -  All patients must have a histologically or cytologically proven diagnosis of
             adenocarcinoma of the prostate. All patients must have metastatic disease as evidenced
             by soft tissue and/or bony metastases prior to initiation of androgen deprivation
             therapy (ADT). NOTE: ADT does not include treatment with anti-androgens such as
             bicalutamide or flutamide or five alpha reductase inhibitors such as finasteride or
             dutasteride.

          -  Patients must have radiographic assessments of all disease including bone scan (or PET
             scan) within 42 days prior to registration. All disease will be assessed and
             documented on the appropriate CRF.

          -  Patients must have had no more than 42 days of prior castration (medical or surgical)
             for metastatic prostate cancer prior to starting abiraterone. The start date of
             medical castration is considered the day the patient first received an injection of a
             LHRH agonist/antagonist (or orchiectomy), not an oral antiandrogen. • If the method of
             castration was luteinizing hormone releasing hormone (LHRH) agonists (i.e., leuprolide
             or goserelin), the patient must be willing to continue the use of LHRH agonist and add
             Abiraterone + Prednisone treatment. • If the patient was on an antiandrogen (e.g.
             bicalutamide, flutamide), the patient must be willing to switch over to Abiraterone +
             Prednisone treatment. There is no limit on how many days a patient may have been on an
             antiandrogen (e.g. bicalutamide, flutamide) or a five alpha reductase inhibitor (e.g.
             finasteride or dutasteride) prior to going on study and no washout is required.

          -  Patients may have received prior ADT - neoadjuvant and/or adjuvant setting only - but
             it must not have lasted for more than 36 months. Single or combination therapy
             allowed. At least 6 months must have elapsed since completion of ADT in the
             neoadjuvant and/or adjuvant setting, and serum testosterone must be > 50 ng/dL
             (non-castrate levels) within 28 days prior to registration. NOTE: Serum testosterone
             assessment is required for eligibility for only those patients with prior treatment
             with neoadjuvant or adjuvant ADT.

          -  Patients who are deemed to have high-risk or extensive metastatic, hormone sensitive
             prostate cancer (mHSPC) per "clinical judgment" of the treating physician are eligible
             for enrollment if the participants are unsuitable candidates for docetaxel or if the
             participants have declined docetaxel therapy.

          -  Patients may have received prior surgery. For all major surgeries, at least 14 days
             must have elapsed since completion and patient must have recovered from all major side
             effects of surgery per investigator's assessment.

          -  Patients may have received or plan to receive concurrent bone targeting agents that do
             not have an effect on PSA (e.g. denosumab or bisphosphonate).

          -  Patients must have no plans to receive any other experimental therapy while on the
             protocol treatment. Previous experimental therapy must have been completed at least 28
             days prior to registration.

          -  Patients must have a complete physical examination and medical history within 28 days
             prior to registration.

          -  Patients must have a PSA ≥ 10 ng/mL obtained within 90 days prior to registration.

          -  Patients must have a QTc interval < 461 msec on the 12 lead ECG within 42 days prior
             to registration. Patients with asymptomatic or incidental bundle branch blocks may
             have QTc measured by a cardiologist or standard formulas such as Bazett's or
             Fridericia's to adjust for pre-existing blocks.

          -  Patients must have adequate hepatic function, within 28 days prior to registration, as
             evidenced by: • bilirubin ≤ 2 x institutional upper limit of normal (ULN), and • SGOT
             (AST) and SGPT (ALT) ≤ 3 x institutional ULN, or ≤ 5 x institutional ULN if liver
             metastases are present.

          -  Patients must have adequate renal function, within 28 days prior to registration, as
             evidenced by calculated creatinine clearance ≥ 40 mL/min using a serum creatinine or
             by 24-hour urine creatinine (using Cockroft-Gault equation).

          -  Patients must have adequate hematologic function, within 28 days prior to registration
             as evidenced by:

               -  leukocytes ≥ 3,000/mcL,

               -  absolute neutrophil count (ANC) ≥ 1,500/mcL,

               -  hemoglobin ≥ 9 g/dL, and

               -  platelets ≥ 100,000/mcL.

          -  Patients must have a Zubrod performance status of 0-2. Zubrod performance status 3
             will be allowed if from bone pain only.

          -  No other prior malignancy is allowed except for the following: adequately treated
             basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from
             which the patient is currently in complete remission, or any other cancer from which
             the patient has been disease-free for 5 years.

          -  Patients must be ≥ 18 years of age.

          -  Patients or their legally authorized representative must be informed of the
             investigational nature of this study and must sign and give written informed consent
             in accordance with institutional and federal guidelines.

        Voluntary written informed consent must be obtained before performance of any study-related
        procedure not part of normal medical care, with the understanding that consent may be
        withdrawn by the patient at any time without prejudice to future medical care.

        Exclusion Criteria:

          -  Patients with known brain metastases are not eligible. Brain imaging studies are not
             required for eligibility if the patient has no neurologic signs or symptoms suggestive
             of brain metastasis. But, if brain imaging studies are performed, patients must be
             negative for disease.

          -  Patients must not have received prior and/or must not have any plans for receiving
             concomitant therapy with ketoconazole, aminoglutethimide, or enzalutamide (MDV3100).
             Concurrent megestrol for hot flashes is allowed.

          -  Patients must not have received any prior cytotoxic chemotherapy for metastatic
             prostate cancer. Prior cytotoxic chemotherapy with curative intent in the neoadjuvant
             or adjuvant setting is allowed. At least 2 years must have elapsed since completion of
             cytotoxic chemotherapy in the neoadjuvant and/or adjuvant setting.

          -  Patients must not have New York Heart Association Class III or IV heart failure at the
             time of screening. Patients must not have any thromboembolic event, unstable angina
             pectoris, myocardial infarction, or serious uncontrolled cardiac arrhythmia within 6
             months prior to registration. (Note: Androgen deprivation therapy may prolong the
             QT/QTc interval. Patients with congenital long AT syndrome, congestive heart failure,
             frequent electrolyte abnormalities, and patients taking drugs known to prolong the QT
             interval may be at increased risk.)

          -  Patients with a known history of primary and secondary adrenal insufficiency are not
             eligible.

          -  Patients must not be known to have hypersensitivity to abiraterone or to LHRH agonist.

          -  Patients must not have known gastrointestinal (GI) disease or GI procedure that could
             interfere with the GI absorption or tolerance of abiraterone, including difficulty
             swallowing oral medications per investigator's clinical judgement.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:PSA Response Rate
Time Frame:Treatment start until 7 months after start of ADT
Safety Issue:
Description:The proportion of subjects with PSA levels less than 4 ng/ml at the given time point.

Secondary Outcome Measures

Measure:Depth of PSA Response
Time Frame:Treatment start until nadir, or up to 7 months after start of ADT if no nadir
Safety Issue:
Description:Measure of the absolute amount of change in PSA levels, or measure of proportional change in PSA levels.
Measure:Frequency of Potentially Deleterious Polymorphisms
Time Frame:Measured at baseline
Safety Issue:
Description:Number of potentially deleterious polymorphisms in proteins involved in androgen metabolism, stratified by race/ethnicity.
Measure:Progression Free Survival
Time Frame:Treatment start until event or up to 3 years after start of ADT
Safety Issue:
Description:Measure of time until disease progression.
Measure:Time to PSA Progression
Time Frame:Treatment start until event or up to 3 years after start of ADT
Safety Issue:
Description:Measure of time until PSA progression.
Measure:Time to Subsequent Prostate Cancer Therapy
Time Frame:Treatment start until event or up to 3 years after start of ADT
Safety Issue:
Description:Measure of time until start of subsequent prostate cancer therapy.
Measure:Time to Initiation of Chemotherapy
Time Frame:Treatment start until event or up to 3 years after start of ADT
Safety Issue:
Description:Measure of time until start of chemotherapy.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Martha Mims

Trial Keywords

  • Abiraterone acetate
  • hormone naive prostate cancer

Last Updated

July 24, 2019