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Prostate cancer patients may ditch painful hormone shots, study hints

NCT ID NCT03565835

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

31 people

The number who actually took part.

Started

Jun 2018

Finished

Nov 2021

Lead sponsor

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

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.