Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer
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ClinicalTrials.gov Identifier: NCT03565835 |
Recruitment Status :
Active, not recruiting
First Posted : June 21, 2018
Last Update Posted : February 21, 2021
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Condition or disease | Intervention/treatment | Phase |
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Prostatic Neoplasms | Drug: Abiraterone Acetate Drug: Prednisone | Phase 2 |
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 |
Estimated Primary Completion Date : | August 2021 |
Estimated Study Completion Date : | January 2022 |

Arm | Intervention/treatment |
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Experimental: Abiraterone and Prednisone without a GnRH Analogue
Abiraterone (1000 mg daily) with Prednisone (5 mg) with Discontinuation of GnRH Analogue Injection
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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 |
- 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.
- 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.
- 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.
- 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
- Radiographic progression-free survival (rPFS) [ Time Frame: 24 weeks ]To measure the time for trial entry until radiographic progression
- Median overall survival [ Time Frame: 24 weeks ]To measure the median time from trial entry until death

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The patient must be able to provide study-specific informed consent prior to study entry
- Age ≥ 18
- ECOG 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, histerelin, deslorin) 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.
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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

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
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10461 |
Principal Investigator: | Benjamin Gartrell, MD | Montefiore Medical Center |
Responsible Party: | Benjamin Gartrell, Principal Investigator, Montefiore Medical Center |
ClinicalTrials.gov Identifier: | NCT03565835 |
Other Study ID Numbers: |
2017-8506 |
First Posted: | June 21, 2018 Key Record Dates |
Last Update Posted: | February 21, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
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 |
abiraterone prostate cancer androgen deprivation therapy |
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 |