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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03565835
Recruitment Status : Active, not recruiting
First Posted : June 21, 2018
Last Update Posted : December 6, 2021
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Abiraterone Acetate Drug: Prednisone Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer
Actual Study Start Date : June 13, 2018
Actual Primary Completion Date : November 17, 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Abiraterone and Prednisone without a GnRH Analogue
Abiraterone (1000 mg daily) with Prednisone (5 mg) with Discontinuation of GnRH Analogue Injection
 Drug: Abiraterone Acetate
Abiraterone Acectate with Prednisone and with Discontinuation of GnRH Analogue

Drug: Prednisone
Abiraterone Acectate with Prednisone and with Discontinuation of GnRH Analogue


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with a non-castrate (>50 ng/dl) serum testosterone [ Time Frame: 24 weeks ]
    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 :
  1. Luteinizing hormone (LH) level after discontinuation of GnRH analogue [ Time Frame: 24 weeks ]
    To measure serum LH level in patients with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue.

  2. PSA response rate [ Time Frame: 24 weeks ]
    To measure PSA response rate and in patient with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue.

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 24 weeks ]
    To measure the incidence of adverse events

  4. Radiographic progression-free survival (rPFS) [ Time Frame: 24 weeks ]
    To measure the time for trial entry until radiographic progression

  5. Median overall survival [ Time Frame: 24 weeks ]
    To measure the median time from trial entry until death


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565835


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Benjamin Gartrell, MD Montefiore Medical Center
More Information
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Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03565835    
Other Study ID Numbers: 2017-8506
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: December 6, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Montefiore Medical Center:
abiraterone
prostate cancer
androgen deprivation therapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Prednisone
Abiraterone Acetate
Anti-Inflammatory Agents
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors