A Study of Personalized Apalutamide Treatment for Improving Quality of Life in Patients with Prostate Cancer after Post Operative Radiation, PROSTATE-IQ Trial

Status: active

This phase III trial tests the safety and effectiveness of apalutamide in improving quality of life in patients with prostate cancer after post operative radiation. Radiation to the surgical resection site combined with androgen deprivation therapy (ADT) is standard of care. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. ADT is treatment with drugs, such as degarelix, leuprolide, triptorelin, goserelin, or relugolix, used to block production or interfere with the action of male sex hormones (testosterone). Suppressing testosterone can cause significant adverse effects including fatigue, reduced sexual function, and mood changes. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells. Apalutamide does not lower testosterone and may have less side effects such as fatigue, sexual function, hot flashes, and mood changes. Apalutamide may be safe and effective in improving fatigue and quality of life in patients with prostate cancer after post operative radiation.

Inclusion Criteria

Histologically confirmed prostate cancer
Prostate specific antigen (PSA) ≥ 0.1 after radical prostatectomy
Candidate for salvage radiation and ADT treatment, as determined by treating physician
Age > 18 at the time of consent
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Platelet count (plt) ≥ 100,000/uL (within 90 days of registration)
Hemoglobin ≥ 9 g/dL (within 90 days of registration)
Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min using Modification of Diet in Renal Disease (MDRD) Formula (within 90 days of registration)
Bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 90 days of registration) (In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin; if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible
Aspartate aminotransferase (AST) ≤ 2.5 x ULN (within 90 days of registration)
Alanine aminotransferase (ALT) ≤ 2.5 x ULN (within 90 days of registration)
Serum albumin > 3.0 g/dL (within 90 days of registration)
Serum potassium ≥ 3.5 mmol/L (within 90 days of registration)
Ability to understand and comply with study procedures for the entire length of the study as determined by the site investigator or protocol designee
Ability to understand English or Spanish language as determined by the site investigator or protocol designee. Since the primary outcome is a questionnaire available in English and Spanish
Medications known to lower the seizure threshold must be discontinued or substituted 4 weeks prior to cycle 1 day 1 (C1D1) of study treatment for patients on arms receiving apalutamide
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Subject must have the ability to understand and willingness to sign the written informed consent document

Exclusion Criteria

Use of post-prostatectomy testosterone suppression prior to registration (use of GnRH agonist or antagonist, with or without an anti-androgen). However, patients with testosterone recovery after post-prostatectomy testosterone suppression are eligible (testosterone recovery defined as total testosterone > 190 ng/dL) regardless of how long their testosterone was suppressed
Confirmed extrapelvic or bone disease
History of any of the following: * Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to randomization, 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, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization. Any condition that in the opinion of the investigator, would preclude participation in this study
Current evidence of any of the following: * Uncontrolled hypertension (consistently > 160 systolic or > 100 diastolic) * Gastrointestinal disorder affecting absorption * Active infection (eg, human immunodeficiency virus [HIV] or viral hepatitis) * Any condition that in the opinion of the investigator, would preclude participation in this study
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to cycle 1 day 1 (C1D1) of study treatment for patients on arms receiving apalutamide

PRIMARY OBJECTIVES:

I. To compare fatigue at 9 months, as assessed by Functional Assessment of Clinical Illness Therapy-Fatigue (FACIT-F), between patients assigned to six months of apalutamide monotherapy versus six months of gonadotrophin releasing hormone (GnRH)-based ADT. (Artera Low Cohort)

II. To compare fatigue at 24 months, as assessed by FACIT-Fatigue, between patients assigned to six months of GnRH-based ADT plus apalutamide monotherapy versus 24 months of GnRH-based ADT. (Artera High Cohort)

SECONDARY OBJECTIVES:

I. To compare patient-reported quality of life for the two treatment arms (arm 1 versus [vs.] 2 for Artera-Low Cohort and arm 3 vs. 4 for Artera-High Cohort) as measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Expanded Prostate cancer Index Composite (EPIC)-26.

II. To compare physician-reported toxicity for the two treatment arms as measured by Common Terminology Criteria in Adverse Events (CTCAE) version (v) 5.

III. To compare patient-reported activity levels for the two treatment arms as measured by the leisure-time activity questionnaire.

IV. To compare patient activity and sleep for the two treatment arms as measured by patient wearable health bands.

V. To compare cognitive function for the two treatment arms as measured by Patient Reported Outcomes Measurement Information Systems-Cognitive Function (PROMIS-CF) and the Symbol Digit Modality test.

VI. To compare mental health for the two treatment arms as measured by the Health Anxiety and Depression Scale.

VII. To compare changes in glycosylated hemoglobin (HgA1c) and Lipid profiles over time between the two treatment arms.

VIII. To compare time to testosterone recovery between treatment arms.

IX. To compare time to next therapy between treatment arms.

X. To compare progression-free survival, metastasis-free survival, cancer specific mortality and overall survival between treatment arms.

XI. To compare risk of major acute coronary event between treatment arms.

XII. In the subset of patients who agree to optional body composition measurements, to compare change in body composition including visceral fat and skeletal muscle mass between treatment arms.

EXPLORATORY OBJECTIVES:

I. In the subset of patients who agree to correlative studies, to evaluate the association between fatigue and circulating inflammatory cytokines.

II. In the subset of patients who agree to germline testing, to determine if inherited variants in steroidogenic genes influence individual body composition toxicity with androgen signaling inhibition.

III. To evaluate how germline variants interact with tumor intrinsic properties (via Artera) to determine the overall benefit patients derive from finite, intense androgen signaling inhibition in the post-operative setting.

IV. To investigate the relationship between plasma exosomes, Artera tissue pattern, and the germline to somatic interaction.

V. To study the overlap between body composition toxicity and risk for coronary artery disease as measured by radiographic coronary calcifications and lab markers of coronary artery disease.

VI. To evaluate the association between radiation plan metrics and patient-reported urinary and bowel functional changes.

OUTLINE: Patients are assigned to 1 of 2 cohorts based on Artera Artificial Intelligence tissue analysis.

ARTERA LOW COHORT: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo radiation therapy for up to 8 weeks and receive degarelix, leuprolide, triptorelin, goserelin, or relugolix for up to 6 months in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo radiation therapy for up to 8 weeks and receive apalutamide orally (PO) once daily (QD) on days 1-90 of each cycle. Cycles repeat every 90 days for 2 cycles in the absence of disease progression or unacceptable toxicity.

ARTERA HIGH COHORT: Patients are randomized to 1 of 2 arms.

ARM III: Patients undergo radiation therapy for up to 8 weeks and receive degarelix, leuprolide, triptorelin, goserelin, or relugolix for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo dual x-ray absorptiometry (DEXA) scans throughout study.

ARM IV: Patients receive radiation therapy for up to 8 weeks and receive degarelix, leuprolide, triptorelin, goserelin, or relugolix for 6 months and apalutamide PO QD on days 1-90 of each cycle. Cycles repeat every 90 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo DEXA scans throughout study.

Patients undergo blood sample collection, computed tomography (CT) scans, positron emission tomography (PET)/CT scans or magnetic resonance imaging (MRI) and bone scan throughout study and optionally wear

an activity and sleep monitor throughout the study.

After completion of study treatment, patients are followed up every 6 months for 5 years.

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A Study of Personalized Apalutamide Treatment for Improving Quality of Life in Patients with Prostate Cancer after Post Operative Radiation, PROSTATE-IQ Trial

Inclusion Criteria

Exclusion Criteria

United States

Texas

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A Study of Personalized Apalutamide Treatment for Improving Quality of Life in Patients with Prostate Cancer after Post Operative Radiation, PROSTATE-IQ Trial

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