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

Primary Purpose

Prostatic Neoplasms

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Abiraterone Acetate

Prednisone

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring abiraterone, prostate cancer, androgen deprivation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

The patient must be able to provide study-specific informed consent prior to study entry
Age ≥ 18
ECOG (Eastern Cooperative Oncology Group) Performance Status 0-2
Pathologically proven diagnosis of prostate adenocarcinoma
Patients must have metastatic prostate cancer
Patients may have mCRPC or may have metastatic castration-sensitive disease.
Patients must be maintained on a GnRH analogue (agonist (leuprolide, goserelin, triptorelin, histrelin, deslorelin) or antagonist (degarelix))
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.
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:
History of bilateral orchiectomy
History of hypopituitarism
For patient not yet started on abiraterone with prednisone, uncontrolled hypertension (systolic blood pressure >170 mm Hg or diastolic blood pressure >100 mm Hg)
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
Any other serious illness or medical condition that the principal investigator feels would make the patient a poor candidate for this study

Sites / Locations

Montefiore Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abiraterone and Prednisone without a GnRH Analogue

Arm Description

Abiraterone (1000 mg daily) with Prednisone (5 mg) with Discontinuation of GnRH Analogue Injection

Outcomes

Primary Outcome Measures

Proportion of patients with a non-castrate (>50 ng/dl) serum testosterone

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

Luteinizing hormone (LH) level after discontinuation of GnRH analogue

To measure serum LH level in patients with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue.

PSA (Prostate-specific antigen) response rate

To measure PSA response rate and in patient with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue.

Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

To measure the incidence of adverse events

Radiographic progression-free survival (rPFS)

To measure the time for trial entry until radiographic progression

Median overall survival

To measure the median time from trial entry until death

Full Information

NCT ID

NCT03565835

First Posted

May 29, 2018

Last Updated

September 22, 2022

Sponsor

Montefiore Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03565835

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 13, 2018 (Actual)

Primary Completion Date

November 17, 2021 (Actual)

Study Completion Date

January 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Neoplasms

Keywords

abiraterone, prostate cancer, androgen deprivation therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Abiraterone and Prednisone without a GnRH Analogue

Arm Type

Experimental

Arm Description

Abiraterone (1000 mg daily) with Prednisone (5 mg) with Discontinuation of GnRH Analogue Injection

Intervention Type

Drug

Intervention Name(s)

Abiraterone Acetate

Intervention Description

Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue

Primary Outcome Measure Information:

Title

Proportion of patients with a non-castrate (>50 ng/dl) serum testosterone

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.

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Luteinizing hormone (LH) level after discontinuation of GnRH analogue

Description

To measure serum LH level in patients with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue.

Time Frame

24 weeks

Title

PSA (Prostate-specific antigen) response rate

Description

To measure PSA response rate and in patient with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue.

Time Frame

24 weeks

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

Description

To measure the incidence of adverse events

Time Frame

24 weeks

Title

Radiographic progression-free survival (rPFS)

Description

To measure the time for trial entry until radiographic progression

Time Frame

24 weeks

Title

Median overall survival

Description

To measure the median time from trial entry until death

Time Frame

24 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patient must be able to provide study-specific informed consent prior to study entry Age ≥ 18 ECOG (Eastern Cooperative Oncology Group) Performance Status 0-2 Pathologically proven diagnosis of prostate adenocarcinoma Patients must have metastatic prostate cancer Patients may have mCRPC or may have metastatic castration-sensitive disease. Patients must be maintained on a GnRH analogue (agonist (leuprolide, goserelin, triptorelin, histrelin, deslorelin) or antagonist (degarelix)) 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. Lab values meeting the following criteria Total testosterone level of <50 ng/dl Total bilirubin < 2.0 X Upper Limit of Normal (ULN) Aspartate aminotransferase (AST) ≤ 3 X ULN Alanine aminotransferase (ALT ) ≤ 3 X ULN Absolute Neutrophil Count > 1.5 K/mm3 Platelets > 100 K/mm3 Hemoglobin ≥9.0 g/dL calculated creatinine clearance ≥ 30 mL/min Exclusion Criteria: History of bilateral orchiectomy History of hypopituitarism For patient not yet started on abiraterone with prednisone, uncontrolled hypertension (systolic blood pressure >170 mm Hg or diastolic blood pressure >100 mm Hg) 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 Any other serious illness or medical condition that the principal investigator feels would make the patient a poor candidate for this study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benjamin Gartrell, MD

Organizational Affiliation

Montefiore Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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