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Abiraterone and Prednisone or Darolutamide for Advanced Prostate Cancer

This study is looking at two different treatments for advanced prostate cancer: abiraterone (which lowers male hormones) and prednisone (to reduce inflammation), or darolutamide (which blocks male hormones from reaching cancer cells). The goal is to see how well patients tolerate these treatments, specifically looking at serious side effects over 12 months. You may be able to join if you have prostate adenocarcinoma that has spread and your doctor thinks one of these treatments is appropriate for you. You should also be 18 years or older. This study is currently unclear on its recruitment status and plans to enroll about 75 participants.

Study design
This study is an interventional trial, meaning participants receive a specific treatment. It will enroll about 75 participants, who will be assigned to one of two treatment groups based on their doctor's preference.
What's involved
You would receive either abiraterone and prednisone, or darolutamide, for one year. You would also have blood samples collected during screening and throughout the study.
Compensation
Not stated in the trial record.
Follow-up
After treatment, participants will be followed for a total of 3 years.

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NCT06173362

Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of California, Davis
~75 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:AbirateroneBiospecimen CollectionDarolutamidePrednisone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of grade 3 or higher adverse events
Measured over At 12 months

Conditions

Advanced Prostate Adenocarcinoma
Stage III Prostate Cancer AJCC v8
Stage IV Prostate Cancer AJCC v8

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Mamta Parikh · PRINCIPAL_INVESTIGATOR · University of California, Davis

Who to contact

OCR Referral Team
[email protected]
916-382-6970
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Ability to understand and willingness to sign an informed consent form
Histologically confirmed prostate adenocarcinoma
Advanced prostate cancer appropriate for treatment with abiraterone acetate plus prednisone or darolutamide as assessed by the treating physician
Participants are encouraged to be currently treated with androgen deprivation therapy (ADT) or having undergone bilateral orchiectomy
Performance status 0 - 2 (Karnofsky ≥ 50%)
Age ≥ 18 years at time of consent
Life expectancy ≥ 6 months per investigator discretion
Ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study

Exclusion

Have been on either abiraterone or darolutamide for \> 28 days prior to initiating enrollment
Any condition that in the opinion of the investigator would prohibit the understanding or rendering of informed consent or interfere with the participant's safety or compliance while on trial

What this trial measures

  • Incidence of grade 3 or higher adverse eventsAt 12 months

    Will be defined and graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0).