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Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer

Advanced ChemoHormonal Therapy for Treatment Naïve Metastatic Prostate Cancer: Apalutamide and Abiraterone Acetate With Prednisone and Androgen Deprivation Therapy After Treatment With Docetaxel and Androgen Deprivation Therapy

NCT04267887•OHSU Knight Cancer Institute

View on ClinicalTrials.gov

Summary

This phase II trial studies how well the combination of apalutamide, abiraterone acetate, and prednisone after chemotherapy work in treating patients that have received no prior treatment (treatment naive) for high risk prostate cancer that is sensitive to androgen deprivation therapy (castration sensitive) and has spread to other parts of the body (metastatic). This study also aims to understand the inheritance of prostate cancer. If a gene or genes that cause prostate cancer can be found, the diagnosis and treatment of prostate cancer may be improved. Testosterone (a male hormone) can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Antihormone therapy, such as abiraterone acetate, may lessen the amount of testosterone made by the body. Anti-inflammatory drugs such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Apalutamide, abiraterone acetate, and prednisone after chemotherapy may work better in treating patients with castration sensitive prostate cancer.

Detailed Description

PRIMARY OBJECTIVE: I. Efficacy of apalutamide in combination with abiraterone acetate + prednisone following docetaxel with ongoing androgen deprivation therapy in men with high risk metastatic castration sensitive disease. SECONDARY OBJECTIVES: I. Safety and tolerability of apalutamide in combination with abiraterone acetate + prednisone following docetaxel with ongoing androgen deprivation therapy. II. Time to event. III. Depth of prostate specific antigen (PSA) response. EXPLORATORY OBJECTIVES: I. Quality of life. II. Falls. III. Molecular changes from prostate cancer over time. OUTLINE: Patients receive apalutamide orally (PO) once daily (QD), abiraterone acetate PO QD, and prednisone PO QD. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive androgen deprivation therapy per standard of care. Patients undergo computed tomography (CT) scan, bone scan and blood sample collection throughout the study. After completion of study treatment, patients are followed up every 6 months for up to 10 years.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Patients must have histologically or cytologically confirmed prostate cancer OR a strong suspicion of prostate cancer as evidenced by metastatic disease in a pattern consistent with prostate cancer (such as blastic lesions on a nuclear medicine bone scan or lymphadenopathy on the computed tomography \[CT\] scan) AND a PSA \> 50 ng/mL
•Patients must meet either of the definitions for high risk disease as follows:
•* Definition 1: Must have at least 2 of the following 3 at the time diagnosed metastatic:
•* visceral metastatic disease
•* \>=3 bone lesions
•* Gleason 8-10 OR
•* Definition 2: \>=4 bone lesions, including \>=1 outside of the vertebral column or pelvis and/or visceral metastatic disease
•If a patient has received androgen deprivation therapy (ADT) for neoadjuvant or adjuvant therapy at least 24 months MUST have elapsed since its use to day 1 of restarting ADT for metastatic castration sensitive disease
•ADT sensitive disease- no evidence of PSA progression or new metastatic deposits since starting ADT; PSA progression is defined as an increase in PSA greater than 25% above nadir, and \>2 ng/ml increase confirmed by a second value obtained at least 2 weeks apart
•Have completed up to 6 cycles of docetaxel since developing metastatic castration sensitive disease with no more than 16 weeks elapsed since day 21 of the final cycle
+15 more criteria

Exclusion Criteria

•Subjects who are unwilling to stop taking saw palmetto, PC-SPECs or other herbal agents known to affect the PSA
•Patients may not have received any other investigational agents within 30 days prior to day 1 of study
•Prior exposure to apalutamide, enzalutamide, abiraterone acetate, darolutamide, or any other second-generation antiandrogen therapy
•* Note: prior exposure to bicalutamide, flutamide, nilutamide, or any other first-generation androgen receptor antagonist is permitted. No washout is required. Subjects may be on one of these at the time of consent, but it must be stopped prior to day 1 of study treatment. These drugs are frequently used in the newly diagnosed metastatic setting to blunt the effect of the testosterone spike
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to apalutamide or other agents used in the study
•Subject has another active malignancy other than non-melanomatous skin cancer (unless it is metastatic) or superficial bladder cancer
•Either of the following:
•* Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system \[CNS\] or meningeal disease which may require treatment with surgery or radiation therapy)
•* Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure or left ventricular ejection fraction \< 50%, arterial or venous thromboembolic events (e.g. pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to day 1 of study
•Current evidence of any of the following:
+16 more criteria

Locations (1)

OHSU Knight Cancer Institute

Portland, Oregon, United States

Key Dates

Start Date

May 11, 2020

Primary Completion Date

January 1, 2028

Completion Date

January 1, 2030

Last Updated

January 20, 2026

Enrollment

ACTUAL participants

Conditions

Castration-Sensitive Prostate CarcinomaMetastatic Prostate CarcinomaStage IVB Prostate Cancer AJCC v8

Interventions

Abiraterone Acetate

DRUG

Antiandrogen Therapy

DRUG

Apalutamide

DRUG

Prednisone

DRUG

Computed Tomography

PROCEDURE

Bone Scan

PROCEDURE

Biospecimen Collection

PROCEDURE

Questionnaire Administration

OTHER

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Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer

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Castration-Resistant Prostate CarcinomaMetastatic Prostate Carcinoma+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer

Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer

Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recurrent and Metastatic Prostate Cancer

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SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma