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Hormone Therapy

Arm II (darolutamide) for Prostate Cancer

Phase 2

Recruiting

Research Sponsored by Mamta Parikh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Performance status 0 - 2 (Karnofsky ≥ 50%)

Histologically confirmed prostate adenocarcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 months

Awards & highlights

Study Summary

This trial compares abiraterone+prednisone vs darolutamide in advanced prostate cancer to see which has better side effects.

Who is the study for?

This trial is for men with advanced prostate cancer that has spread beyond the original site. Participants should not have had prior treatment with abiraterone, prednisone, or darolutamide. They must be able to provide tissue samples and willing to follow study procedures.Check my eligibility

What is being tested?

The trial compares two treatments: one group receives abiraterone plus prednisone (standard care), while the other gets just darolutamide. The goal is to see which treatment better stops tumor growth by affecting male hormone levels or blocking their use by tumors.See study design

What are the potential side effects?

Abiraterone can cause high blood pressure, heart issues, liver problems, and muscle pain. Prednisone may lead to weight gain, mood changes, increased infection risk, and bone thinning. Darolutamide might result in fatigue, nausea, and skin rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but may not be able to do active work.

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My prostate cancer was confirmed through a tissue examination.

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I can and will follow the study's schedule and rules.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of grade 3 or higher adverse events

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (darolutamide)Experimental Treatment2 Interventions

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.

Group II: Arm I (abiraterone, prednisone)Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2370

Abiraterone

2012

Completed Phase 4

~2830

Biospecimen Collection

2004

Completed Phase 2

~1700

Darolutamide

2018

Completed Phase 2

~100

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mamta ParikhLead Sponsor

6 Previous Clinical Trials

135 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,366 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,095 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Arm II (darolutamide) received governmental sanction for public use?

"The safety of Arm II (darolutamide) was rated a 2 due to the lack of evidence for efficacy in Phase 2 clinical trials, however there is some data affirming its security."

Answered by AI

Is there availability for new participants in this clinical experiment?

"From the data hosted on clinicaltrials.gov, it is evident that this study has open recruitment and was initially posted in November 9th 2023 with its last update being made in December 7th of the same year."

Answered by AI

How many volunteers have consented to participate in this research?

"Affirmative. Evidenced on clinicaltrials.gov, this medical trial is currently accepting participants and was initially listed 11/9/2023 with the most recent edit being 12/7/2023. The enrolment goals are 75 patients from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Mamta Parikh 2023. "Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06173362.

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