New drug cocktail shows promise for tough prostate cancer
NCT ID NCT03934840
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
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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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61 people
The number who actually took part.
- Started
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Oct 2019
- Finished
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Apr 2025
- 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.
Show the full entry requirements Hide 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
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Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
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Lifespan Cancer Institute
Providence, Rhode Island, 02903, United States
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Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455, United States
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Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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Thomas Jeferson University
Philadelphia, Pennsylvania, 19107, United States
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Tulane University
New Orleans, Louisiana, 70112, United States
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University of Chicago
Chicago, Illinois, 60637, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?