Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer

NCT04267887 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY00016728NCI-2020-00598
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8; Castration-Sensitive Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• Complete prostate specific antigen (PSA) response

  The complete PSA response is defined as a PSA =\< 0.2 ng/ml, confirmed with a 2nd measurement at least 3 weeks later. The estimated PSA response rate will be computed with 95% exact confidence interval. Binomial exact test will be used to determine whether the complete PSA response rate is significantly greater than 43%.

  At 12 months from the start of treatment

Secondary Outcomes (9)

• Overall survival

  From day 1 of treatment, assessed up to 10 years

• Incidence of adverse events >= grade 2

  Up to 10 years

• Proportion of patients with PSA response >= 50% decrease

  From baseline, assessed up to 12 months

• Proportion of patients with PSA response >= 90% decrease

  From baseline, assessed up to 12 months

• Time to treatment failure

  From start of treatment, assessed up to 10 years

Study Arms (1)

Treatment (apalutamide, abiraterone acetate, prednisone, ADT)

EXPERIMENTAL

Patients receive apalutamide PO 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 CT scan, bone scan and blood sample collection throughout the study.

Drug: Abiraterone Acetate; Drug: Antiandrogen Therapy; Drug: Apalutamide; Drug: Prednisone; Procedure: Computed Tomography; Procedure: Bone Scan; Procedure: Biospecimen Collection; Other: Questionnaire Administration

Interventions

Abiraterone Acetate DRUG

Given PO

Also known as: CB7630, Yonsa, Zytiga

Treatment (apalutamide, abiraterone acetate, prednisone, ADT)

Antiandrogen Therapy DRUG

Given ADT per standard of care

Also known as: ADT, Androgen Deprivation Therapy, Androgen Deprivation Therapy (ADT), Anti-androgen Therapy, Anti-androgen Treatment, Antiandrogen Treatment, Hormone Deprivation Therapy, Hormone-Deprivation Therapy

Treatment (apalutamide, abiraterone acetate, prednisone, ADT)

Apalutamide DRUG

Given PO

Also known as: ARN 509, ARN-509, ARN509, Erleada, JNJ 56021927, JNJ-56021927

Treatment (apalutamide, abiraterone acetate, prednisone, ADT)

Prednisone DRUG

Given PO

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

Treatment (apalutamide, abiraterone acetate, prednisone, ADT)

Computed Tomography PROCEDURE

Undergo CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan

Treatment (apalutamide, abiraterone acetate, prednisone, ADT)

Bone Scan PROCEDURE

Undergo bone scan

Also known as: Bone Scintigraphy

Treatment (apalutamide, abiraterone acetate, prednisone, ADT)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

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

Treatment (apalutamide, abiraterone acetate, prednisone, ADT)

Questionnaire Administration OTHER

Ancillary studies

Treatment (apalutamide, abiraterone acetate, prednisone, ADT)

Eligibility Criteria

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

You may qualify if:

• 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
• All races and ethnic groups will be included
• Life expectancy of greater than 18 months
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• Hemoglobin \> 9.0 g/dL, independent of transfusion and/or growth factors
• Leukocytes \> 3,000/uL

You may not qualify if:

• 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:
• Uncontrolled hypertension
• Gastrointestinal disorder affecting absorption
• Active infection (e.g. human immunodeficiency virus \[HIV\] or viral hepatitis)
• Any chronic medical condition requiring a higher dose of corticosteroid than a total of 10 mg prednisone/prednisolone daily
• Any condition that in the opinion of the investigator, would preclude participation in this study.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Janssen Scientific Affairs, LLC: collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; Androgen Antagonists; apalutamide; Prednisone; deltacortene; prednylidene; Specimen Handling

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)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pregnadienediols; Pregnadienes; Pregnanes; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Julie Graff, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: May 11, 2020
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)