Prostate cancer patients may ditch painful hormone shots, study hints
NCT ID NCT03565835
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether men with advanced prostate cancer could safely stop their regular hormone injections (like leuprolide) and rely only on the pills abiraterone and prednisone to keep testosterone at very low levels. 31 men participated. The goal was to see if testosterone stayed low enough to control the cancer without the shots. The results help doctors understand if this simpler pill-only approach is possible.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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31 people
The number who actually took part.
- Started
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Jun 2018
- Finished
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Nov 2021
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * The patient must be able to provide study-specific informed consent prior to study entry * Age ≥ 18 * Eastern Cooperative Oncology Group (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, 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 patients 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Montefiore Medical Center
The Bronx, New York, 10461, United States
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Other studies related to the condition(s) this trial covers.
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