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New drug cocktail shows promise for tough prostate cancer

NCT ID NCT03934840

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase II trial tested a combination of three drugs—carboplatin, cabazitaxel, and abiraterone—in 61 men with high-volume metastatic prostate cancer that still responds to hormone therapy. The goal was to see how many men had no cancer growth after one year. The study also tracked side effects and how long the cancer stayed under control.

What this could mean

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

Active substance
carboplatin, cabazitaxel, abiraterone, and prednisone
What this could lead to
If successful, this combination could offer a new treatment option to delay cancer progression in men with advanced prostate cancer.
What could go wrong
This is a small, early-phase trial with only 61 participants. The combination may cause significant side effects, and results may not apply to all patients.

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

61 people

The number who actually took part.

Started

Oct 2019

Finished

Apr 2025

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: * Willing and able to provide, or have a legally authorized representative provide, written informed consent and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed. * Histologically confirmed prostate cancer. * High volume metastatic disease (defined as the presence of visceral metastases or ≥3 bone lesions). * ADT for ≤3 months by day 1 of study chemotherapy; Prior episodes of ADT are allowed (i.e. ADT used previously in courses of radiation). * Testosterone \<50 ng/dL. Patients must continue primary ADT with an LHRH analogue if they have not undergone orchiectomy. * ECOG Performance Status 0 or 1 (see Appendix A) * Patient has adequate bone marrow and organ function as defined by the following laboratory values: * Absolute neutrophil count ≥ 1.5 × 10\^9/L * Platelets ≥ 100 × 10\^9/L * Hemoglobin ≥ 9 g/dl * Serum creatinine ≤ 1.5mg/dL or estimated creatinine clearance ≥ 50 ml/min * In the absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2.5 x ULN. If the patient has liver metastases, ALT and AST \<5 x ULN * Total bilirubin \< ULN; or total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x ULN in patients with well-documented Gilbert's Syndrome. * Sexually active males must use a condom during intercourse while taking study drugs and for 30 days after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. Fertile males must use a condom with spermicide (double barrier method). * Age ≥ 18 years Exclusion Criteria: * Prior exposure to any chemotherapy, PARPi, or immunotherapy for prostate cancer. * Prior abiraterone or enzalutamide, unless therapy was for \< 2 weeks * Radiation therapy (including palliative radiotherapy to a metastatic lesion) within 14 days or major surgery (e.g., open abdominal, pelvic, thoracic, orthopedic or neurosurgery) within 28 days of the date of the first dose. * Other systemic therapies for prostate cancer within 28 days or 5 half-lives, whichever is shorter, prior to day 1 of chemotherapy (with the exception of anti-androgens like bicalutamide). * PSA \<2.0 ng/mL at diagnosis. * If present, peripheral neuropathy must be ≤ Grade 1 * Patients with an active second malignancy that could, in the investigator's opinion, potentially interfere with the patient's ability to participate and/or complete this trial. * Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria: * At least 4 weeks from prior therapy completion (including radiation and/or surgery) prior to starting the study treatment * Clinically stable CNS tumor at the time of screening. * Baseline screening for CNS metastases is not required unless presence of signs and/or symptoms of involvement * Patients with severe psychiatric illness/social situations that would limit compliance with study requirements in the judgment of treating investigator. * Patient has a history of non-compliance to medical regimen or inability to grant consent.

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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

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169, United States

  • Lifespan Cancer Institute

    Providence, Rhode Island, 02903, United States

  • Masonic Cancer Center at University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Thomas Jeferson University

    Philadelphia, Pennsylvania, 19107, United States

  • Tulane University

    New Orleans, Louisiana, 70112, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

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