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

NCT06173362 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: UCDCC315NCI-2023-09814P30CA093373
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of grade 3 or higher adverse events

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

  At 12 months

Study Arms (2)

Arm I (abiraterone, prednisone)

EXPERIMENTAL

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.

Drug: Abiraterone; Procedure: Biospecimen Collection; Drug: Prednisone

Arm II (darolutamide)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Drug: Darolutamide

Interventions

Abiraterone DRUG

Given abiraterone

Also known as: CB 7598

Arm I (abiraterone, prednisone)

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (abiraterone, prednisone); Arm II (darolutamide)

Darolutamide DRUG

Given darolutamide

Also known as: Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201

Arm II (darolutamide)

Prednisone DRUG

Given prednisone

Also known as: .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

Arm I (abiraterone, prednisone)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

abiraterone; Specimen Handling; darolutamide; Prednisone; deltacortene; prednylidene

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mamta Parikh

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

OCR Referral Team

CONTACT

916-382-6970; OCRReferral@health.ucdavis.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: November 9, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (1)