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Can doubling the dose stop prostate cancer from worsening?

NCT ID NCT03458247

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at men with advanced prostate cancer that no longer responds to hormone therapy. When the standard dose of abiraterone stopped working, some patients received a double dose to see if it could stabilize the disease. The goal was to find out if this approach is safe and effective for those with low drug levels in their blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
abiraterone acetate
What this could lead to
If successful, this could show that a higher dose of abiraterone helps control prostate cancer longer in patients who start to progress on the standard dose.
What could go wrong
This is a small, early-phase study without a comparison group, so results may not be definitive. Higher doses may also increase side effects.

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

94 people

The number who actually took part.

Started

Jun 2018

Finished

Dec 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: Step 1 * Male 18 years and older. * Voluntary signed informed consents of the patient before any study-specific procedure. * Histologically confirmed prostate adenocarcinoma. * Presence of bone and/or soft-tissue and/or visceral metastases through CT scan, MRI, scintigraphy scan. * Progressive disease assessed by PSA, CT scan, MRI or bone scan according to the PCGW3 criteria PSA progression is defined as a 25% or greater increase and an absolute increase of 2 ng/mL or more from the nadir, which is confirmed by a second value obtained 1 or more weeks later. Bone scan: at least two or more new lesions are seen on bone scan compared with a prior scan. * Patient with no or moderate symptoms (no need for continuous opioid treatment) * Effective castration confirmed by testosterone plasma level \< 50 ng/dL * ECOG performance status: 0-2 * Life expectancy \> 3 months * Patient affiliate to french social assurance * Laboratory criteria within 14 days before inclusion: * SGPT and SGOT \< 5 fold the upper normal value * Kaliemia \> 3 mM * Patient using an effective contraceptive method during treatment Step2 * Patients receiving ABI 1000 mg/day + prednisone/prednisolone 10 mg once a day through step 1 for at least two months * At least two measures of ABI plasma concentrations available within the first three months of treatment * Mean of ABI concentration \< 8,5 ng/mL. * Progressive disease occuring within 28 weeks following starting of ABI in the step 1. A progressive disease is assessed by PSA increase or bone scan according to PCWG3 criteria (15) or to CT scan according to RECIST 1.1 criteria (see § 2). * Inclusion in step 2 must occur within 2 months following the first observation of cancer progression while in step 1. * Patient using an effective contraceptive method during treatment Exclusion Criteria: Step 1 * Pure small cell carcinoma of the prostate or predominant histology of neuro-endocrine carcinoma. * Confirmed brain and/or leptomeningeal metastases * Previous treatment with docetaxel or any other anticancer treatment for castration-resistant prostate carcinoma (previous docetaxel for hormone-sensitive metastatic disease is allowed) * Previous treatment with ABI or any other 17 B hydroxylase inhibitor or enzalutamide * Treatment with first-generation antiandrogen (ciproterone acetate, bicalutamide, flutamide, nilutamide) performed on the day of baseline or within previous four weeks, due to possible anti-androgen withdrawal response. (This criterion does not apply for subjects, who have never responded to anti-androgen treatment). * Patient co-morbidities: * Patients with the following hereditary diseases: galactose hypersensitivity, Lapp lactase deficiency. * Cirrhosis Child-Pugh B or C * Active or symptomatic viral hepatitis * Heart failure stage NYHA III or IV * Cardiac arythmia, heart failure stage NYHA II, ischemic cardiopathy or uncontroled hypertension, except if left ventricular ejection fraction is \> 50% * Patients with left ventricular ejection fraction (LVEF) \< 50% * Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications.Prior or concurrent malignant disease in complete remission for less than 3 years, except T1N0 vocal cord carcinoma, basal or squamous cell skin carcinoma and in situ transitional cell bladder carcinoma * Limitation of the patient's ability to comply with the treatment or to follow-up the protocol. Step 2 Grade 3-4 toxicities related to ABI. In case of persistent grade 2 toxicity, inclusion in step 2 must be discussed in a case by case basis with the study coordinating Investigator. * All non-inclusion criteria for step 1 applied * Patient who is not adherent to ABI treatment at the investigator opinion * Patient with a symptomatic and/or visceral tumor progression that would be an indication to start chemotherapy immediately according to the opinion of the investigator

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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

  • Department of Medical Oncology, Cochin Hospital

    Paris, Paris, 75014, France

More trials for these conditions

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