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

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.

Study Overview

• Status: Recruiting
• Conditions: Stage IV Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Advanced Prostate Adenocarcinoma
• Intervention / Treatment: Procedure: Biospecimen Collection; Drug: Abiraterone; Drug: Prednisone; Drug: Darolutamide

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of California Davis Comprehensive Cancer Center
      • Principal Investigator: Mamta Parikh
      • Contact: Mamta Parikh; Phone Number: 916-734-3772; Email: mbparikh@ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Biospecimen Collection; Undergo collection of blood samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Drug: Abiraterone; Given abiraterone; Other Names: CB 7598; Drug: Prednisone; Given prednisone; Other Names: Deltasone; Orasone; .delta.1-Cortisone; 1, 2-Dehydrocortisone; Adasone; Cortancyl; Dacortin; DeCortin; Decortisyl; Decorton; Delta 1-Cortisone; Delta-Dome; Deltacortene; Deltacortisone; Deltadehydrocortisone; Deltison; Deltra; Econosone; Lisacort; Meprosona-F; Metacortandracin; Meticorten; Ofisolona; Panafcort; Panasol-S; Paracort; Perrigo Prednisone; PRED; Predicor; Predicorten; Prednicen-M; Prednicort; Prednidib; Prednilonga; Predniment; Prednisone Intensol; Prednisonum; Prednitone; Promifen; Rayos; Servisone; SK-Prednisone
Experimental: 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.	Procedure: Biospecimen Collection; Undergo collection of blood samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Drug: Darolutamide; Given darolutamide; Other Names: ODM-201; Nubeqa; Antiandrogen ODM-201; BAY 1841788; BAY-1841788; BAY1841788; ODM 201

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mamta Parikh
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Mamta Parikh, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Estimated): December 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Prednisone; Cortisone; Androgen Antagonists
• Other Study ID Numbers: UCDCC315 (Other Identifier: University of California Davis Comprehensive Cancer Center); P30CA093373 (U.S. NIH Grant/Contract); NCI-2023-09814 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No