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Recruiting NCT06173362

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

Phase II Interventional Advanced Prostate Adenocarcinoma Stage III Prostate Cancer AJCC v8 Stage IV Prostate Cancer AJCC v8

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Abiraterone, Biospecimen Collection, Darolutamide, Prednisone.
Who it may be relevant to
Registry conditions: Advanced Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pragmatic Phase II Study Evaluating Tolerability in Prostate Cancer Patients Treated With Abiraterone + Prednisone or Darolutamide

Overview

This phase II trial compares the effects, good and/or bad of abiraterone and prednisone or darolutamide alone in treating patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Androgens (male hormones) can cause the growth of prostate tumor cells. Abiraterone acetate lowers the amount of androgens made by the body. This may help stop the growth of prostate tumor cells that need androgen to grow. Darolutamide blocks the use of androgens by the tumor cells. Prednisone is used to lessen inflammation and lower the body's immune response. Researchers want to compare the side effects of standard of care (SOC) abiraterone and prednisone or darolutamide alone in treating patients with advanced prostate cancer.

Detailed description

PRIMARY OBJECTIVE:

I. Tolerability.

SECONDARY OBJECTIVES:

I. Tolerability in prespecified subpopulations.

II. Prostate-specific antigen (PSA) response at 7 months.

OUTLINE: Patients are assigned to 1 of 2 arms per treating physician preference.

ARM I: Patients receive abiraterone and prednisone per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study.

ARM II: Patients receive darolutamide per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study.

After completion of study intervention, patients are followed up for a total of 3 years.

Interventions

  • Drug Abiraterone
    Given abiraterone
  • Procedure Biospecimen Collection
    Undergo collection of blood samples
  • Drug Darolutamide
    Given darolutamide
  • Drug Prednisone
    Given prednisone

Primary outcome measures

  • Incidence of grade 3 or higher adverse events [Time frame: At 12 months]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of California Davis Comprehensive Cancer Center — Sacramento

Identifiers

NCT: NCT06173362 · UCDCC315 · NCI-2023-09814 · UCDCC315 · P30CA093373

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗