Clinical Trials /

Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer

NCT03565835

Description:

The goal of this study is to find out if patients with prostate cancer being treated with the medications abiraterone and prednisone can discontinue hormone injections (examples include leuprolide, goserelin, triptorelin and degarelix). Abiraterone and prednisone are pills used to treat patients with prostate cancer. When abiraterone and prednisone are used, hormone injections are usually continued to maintain a low testosterone level in the blood. This study is being done to find out if testosterone in the blood will stay low while abiraterone and prednisone are used without continued hormone injections.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer
  • Official Title: Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: 2017-8506
  • NCT ID: NCT03565835

Conditions

  • Prostatic Neoplasms

Interventions

DrugSynonymsArms
Abiraterone AcetateAbiraterone and Prednisone without a GnRH Analogue
PrednisoneAbiraterone and Prednisone without a GnRH Analogue

Purpose

The goal of this study is to find out if patients with prostate cancer being treated with the medications abiraterone and prednisone can discontinue hormone injections (examples include leuprolide, goserelin, triptorelin and degarelix). Abiraterone and prednisone are pills used to treat patients with prostate cancer. When abiraterone and prednisone are used, hormone injections are usually continued to maintain a low testosterone level in the blood. This study is being done to find out if testosterone in the blood will stay low while abiraterone and prednisone are used without continued hormone injections.

Detailed Description

      Abiraterone inhibits the CYP17A enzyme, which is a critical enzyme in androgen biosynthesis.
      Abiraterone has regulatory approval in metastatic castration-resistant prostate cancer
      (mCRPC) in both chemotherapy-naïve and in the post-docetaxel setting based upon results from
      two randomized phase III studies. Abiraterone is also proven to extend survival in the
      metastatic, hormone-naïve population based on two phase III studies. Abiraterone is a
      castrating agent, but, other than a small first in human study, all clinical studies have
      been done in conjunction with gonadotropin-releasing hormone (GnRH) analogues. Maintaining
      castrate level of serum testosterone is critical in the treatment of metastatic prostate
      cancer. It is unknown if GnRH analogues must be continued to maintain castrate levels of
      serum testosterone in patients treated with abiraterone.
    

Trial Arms

NameTypeDescriptionInterventions
Abiraterone and Prednisone without a GnRH AnalogueExperimentalAbiraterone (1000 mg daily) with Prednisone (5 mg) with Discontinuation of GnRH Analogue Injection
  • Abiraterone Acetate
  • Prednisone

Eligibility Criteria

        Inclusion Criteria:

          1. The patient must be able to provide study-specific informed consent prior to study
             entry

          2. Age ≥ 18

          3. ECOG Performance Status 0-2

          4. Pathologically proven diagnosis of prostate adenocarcinoma

          5. Patients must have metastatic prostate cancer

          6. Patients may have mCRPC or may have metastatic castration-sensitive disease.

          7. Patients must be maintained on a GnRH analogue (agonist (leuprolide, goserelin,
             triptorelin, histerelin, deslorin) or antagonist (degarelix))

          8. The patient and the investigator have decided that the next line of cancer therapy
             will be abiraterone plus prednisone and the initial dose of abiraterone will be 1000
             mg daily. Or patients may already be on abiraterone with prednisone at a dose of 1000
             mg daily along with a GnRH analogue.

          9. Lab values meeting the following criteria

               1. Total testosterone level of <50 ng/dl

               2. Total bilirubin < 2.0 X Upper Limit of Normal (ULN)

               3. Aspartate aminotransferase (AST) ≤ 3 X ULN

               4. Alanine aminotransferase (ALT ) ≤ 3 X ULN

               5. Absolute Neutrophil Count > 1.5 K/mm3

               6. Platelets > 100 K/mm3

               7. Hemoglobin ≥9.0 g/dL

               8. calculated creatinine clearance ≥ 30 mL/min

             Exclusion Criteria:

         10. History of bilateral orchiectomy

         11. History of hypopituitarism

         12. For patient not yet started on abiraterone with prednisone, uncontrolled hypertension
             (systolic blood pressure >170 mm Hg or diastolic blood pressure >100 mm Hg)

         13. Patients must not have New York Heart Association Class III or IV heart failure at the
             time of screening. Patients must not have any unstable angina, myocardial infarction,
             or serious uncontrolled cardiac arrhythmia within 6 months prior to registration

         14. Any other serious illness or medical condition that the principal investigator feels
             would make the patient a poor candidate for this study
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Proportion of patients with a non-castrate (>50 ng/dl) serum testosterone
Time Frame:24 weeks
Safety Issue:
Description:To assess the proportion of patients with a non-castrate testosterone level (>50 ng/dl) when abiraterone acetate plus prednisone is used without GnRH analogues in metastatic prostate cancer.

Secondary Outcome Measures

Measure:Luteinizing hormone (LH) level after discontinuation of GnRH analogue
Time Frame:24 weeks
Safety Issue:
Description:To measure serum LH level in patients with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue.
Measure:PSA response rate
Time Frame:24 weeks
Safety Issue:
Description:To measure PSA response rate and in patient with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue.
Measure:Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time Frame:24 weeks
Safety Issue:
Description:To measure the incidence of adverse events
Measure:Radiographic progression-free survival (rPFS)
Time Frame:24 weeks
Safety Issue:
Description:To measure the time for trial entry until radiographic progression
Measure:Median overall survival
Time Frame:24 weeks
Safety Issue:
Description:To measure the median time from trial entry until death

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Montefiore Medical Center

Trial Keywords

  • abiraterone
  • prostate cancer
  • androgen deprivation therapy

Last Updated

November 14, 2019