Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.

Apalutamide

Laboratory Biomarker Analysis

Quality-of-Life Assessment

Questionnaire Administration

Michael Schweizer

This phase II trial studies how well apalutamide works in treating patients with prostate cancer who are in active surveillance. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using androgen receptor antagonist apalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells.

OUTLINE:

Patients receive apalutamide orally (PO) once daily (QD) for 90 days in the absence of disease progression or unacceptable toxicity.

After completion of the study treatment, patients are followed up at 180, 365, 545, and 730 days; and at years 3, 4 and 5 by medical record review.

Apalutamide in Treating Patients With Prostate Cancer Who Are in Active Surveillance

A Phase 2 Study of Apalutamide in Active Surveillance Patients

Negative rate will be presented as the percent of subjects with a negative repeat biopsy, and will be calculated as: (number of patients with a negative biopsy following 90-days of apalutamide) / (total number of patients enrolled on the study) x 100. A 1-sample chi-square test will be used to compare the proportion with a negative repeat biopsy to the null hypothesis value of 20% (above). The 95% confidence interval will be computed.

The percentage of patients who exited active surveillance due to pathologic reclassification (e.g. increasing tumor volume or gleason score) will be computed along with its 95% confidence interval.

Percentage of patients exiting active surveillance for any reason will be computed along with its 95% confidence interval.

Computed along with its 95% confidence interval.

Median treatment free survival will be estimated using Kaplan-Meier methods and 95% confidence interval will be calculated

Prostate-specific antigen progression rate is the proportion of patients that had PSA progression following treatment. PSA progression is as a confirmed rising prostate-specific antigen \>= 2 ng/mL, with subsequent PSA values obtained at least one week apart.

Prostate-specific antigen progression free survival will be estimated using Kaplan-Meier methods and 95% confidence interval will be estimated using Greenwood's formula.

This calculates the percentage of participants with radiographic disappearance of magnetic resonance imaging detectable prostate cancer. This is only in patients with a baseline nodule that is Prostate Imaging Reporting and Data System 3 or more and \> 5 mm.

As assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) surveys. Functional Assessment of Cancer Therapy-Prostate is a validated quality of life survey specific for patients with prostate cancer. The total FACT-P score ranges from 0 to 156, with higher scores indicating better quality of life. The change in FACT-P score between baseline and day 730 is reported.

As assessed using the Short Form-36 (SF-36) survey physical functioning subscale. Short Form-36 is a validated quality of life survey. This is a generic survey to assess an individual's overall well-being, and is not specific to one disease. The SF-36 physical functioning subscale score ranges from 0 to 100, with higher scores indicating better quality of life. The change in SF-36 energy/fatigue subscale score between baseline and day 730 is reported.

As assessed using the Short Form-36 (SF-36) survey energy/fatigue subscale. Short Form-36 is a validated quality of life survey. This is a generic survey to assess an individual's overall well-being, and is not specific to one disease. The SF-36 energy/fatigue subscale score ranges from 0 to 100, with higher scores indicating better quality of life. The change in SF-36 energy/fatigue subscale score between baseline and day 730 is reported.

As assessed using the Short Form-36 (SF-36) survey emotional well being subscale. Short Form-36 is a validated quality of life survey. This is a generic survey to assess an individual's overall well-being, and is not specific to one disease. The SF-36 emotional well being subscale score ranges from 0 to 100, with higher scores indicating better quality of life. The change in SF-36 emotional well being subscale score between baseline and day 730 is reported.

Janssen Scientific Affairs, LLC

National Cancer Institute (NCI)

University of Washington

Assistant Professor, Division of Medical Oncology

Day 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.

Apalutamide: Given PO

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.

Apalutamide: Given PO

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Treatment (Apalutamide)

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Patients deemed to have very low risk disease based on NCCN criteria at the time of enrollment.

Only patients that did not screen fail are included in this analysis.

Patients with very low risk disease at baseline

There are 24 participants who signed the consent form, and only 23 progressed into the treatment phase. One patient was a screen fail.

We acknowledge that the small sample size of this study is one of its primary limitations, which was further challenged by its premature termination.

Dr. Michael Schweizer

These are patients that had 90 days of treatment and had post-treatment biopsies.

Negative (i.e. no Residual Carcinoma) Site Directed and Systematic Prostate Biopsy Rate

Percentage of Patients Exiting Active Surveillance Due to Pathologic Reclassification

Percentage of Patients Exiting Active Surveillance for Any Reason

Percent of Men Undergoing Local Treatment

Local Treatment Free Survival

Prostate-specific Antigen Progression Rate

Prostate-specific Antigen Progression Free Survival as Defined by the Prostate Cancer Working Group 2 Criteria

Only 1 patient had paired MRI at baseline and again at post-treatment.

Spots Global Cancer Trial Database for Apalutamide in Treating Patients With Prostate Cancer Who Are in Active Surveillance

Trial Identification

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Study Description

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