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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares the good and bad effects, including side effects, of abiraterone plus prednisone with darolutamide alone. It is for adults with advanced prostate cancer, which may have spread to nearby tissue, lymph nodes, or other parts of the body.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • A tissue test has confirmed prostate adenocarcinoma, a type of prostate cancer.
  • Your doctor thinks your advanced prostate cancer can be treated with either study treatment.
  • You can understand the study and are willing to sign a consent form.
  • You meet the study's rating for how well you can do daily activities (performance status 0–2; Karnofsky score at least 50%).
  • The study doctor expects you to live at least 6 months.
  • You can and are willing to follow the study visit schedule and other study rules.
  • Treatment to lower male hormones, or past surgery to remove both testicles, is encouraged but not required.

Who can't join

  • You have taken abiraterone or darolutamide for more than 28 days before starting enrollment.
  • The study doctor thinks a health condition would keep you from understanding or giving consent, make the study unsafe for you, or keep you from following study rules.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

CA