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

NCT ID: NCT06173362

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-09

Study Completion Date

2027-05-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I (abiraterone, prednisone)

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.

Group Type EXPERIMENTAL

Abiraterone

Intervention Type DRUG

Given abiraterone

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood samples

Prednisone

Intervention Type DRUG

Given prednisone

Arm II (darolutamide)

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 Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood samples

Darolutamide

Intervention Type DRUG

Given darolutamide

Interventions

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Abiraterone

Given abiraterone

Intervention Type DRUG

Biospecimen Collection

Undergo collection of blood samples

Intervention Type PROCEDURE

Darolutamide

Given darolutamide

Intervention Type DRUG

Prednisone

Given prednisone

Intervention Type DRUG

Other Intervention Names

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CB 7598 Biological Sample Collection Biospecimen Collected Specimen Collection Antiandrogen ODM-201 BAY 1841788 BAY-1841788 BAY1841788 Nubeqa ODM 201 ODM-201 .delta.1-Cortisone 1, 2-Dehydrocortisone Adasone Cortancyl Dacortin DeCortin Decortisyl Decorton Delta 1-Cortisone Delta-Dome Deltacortene Deltacortisone Deltadehydrocortisone Deltasone Deltison Deltra Econosone Lisacort Meprosona-F Metacortandracin Meticorten Ofisolona Orasone Panafcort Panasol-S Paracort Perrigo Prednisone PRED Predicor Predicorten Prednicen-M Prednicort Prednidib Prednilonga Predniment Prednisone Intensol Prednisonum Prednitone Promifen Rayos Servisone SK-Prednisone

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Mamta Parikh

OTHER

Sponsor Role lead

Responsible Party

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Mamta Parikh

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mamta Parikh

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Mamta Parikh

Role: primary

Other Identifiers

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NCI-2023-09814

Identifier Type: REGISTRY

Identifier Source: secondary_id

UCDCC315

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA093373

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UCDCC315

Identifier Type: -

Identifier Source: org_study_id