Apalutamide in Treating Patients With Prostate Cancer Who Are in Active Surveillance
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02721979|
Recruitment Status : Recruiting
First Posted : March 29, 2016
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Adenocarcinoma||Drug: Apalutamide Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Other: Questionnaire Administration||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Apalutamide in Active Surveillance Patients|
|Actual Study Start Date :||November 2, 2017|
|Estimated Primary Completion Date :||May 2, 2020|
|Estimated Study Completion Date :||November 2, 2021|
Experimental: Treatment (apalutamide)
Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
- Negative (i.e. no residual carcinoma) site directed and systematic prostate biopsy rate [ Time Frame: At 90 days ]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.
- Percentage of patients exiting active surveillance due to pathologic reclassification [ Time Frame: At 2 years ]Will be computed along with its 95% confidence interval.
- Percentage of patients exiting active surveillance for any reason [ Time Frame: At 2 years ]Will be computed along with its 95% confidence interval.
- Percent of men undergoing of local treatment [ Time Frame: At 2 years ]Computed along with its 95% confidence interval.
- Local treatment free survival [ Time Frame: Up to 730 days ]Kaplan-Meier methods and 95% confidence interval will be estimated using Greenwood's formula.
- Prostate-specific antigen progression rate as defined by the Prostate Cancer Working Group 2 criteria (i.e. confirmed rising prostate-specific antigen >= 2 ng/mL at least one week apart) [ Time Frame: At 2 years ]Prostate-specific antigen progression rate will be computed along with 95% confidence interval.
- Prostate-specific antigen progression free survival as defined by the Prostate Cancer Working Group 2 criteria [ Time Frame: At 2 years ]Prostate-specific antigen progression free survival will be estimated using Kaplan-Meier methods and 95% confidence interval will be estimated using Greenwood's formula.
- Change in radiographic disappearance of magnetic resonance imaging detectable prostate cancer [ Time Frame: Baseline to up to 90 days ]Only in patients with a baseline nodule that is Prostate Imaging Reporting and Data System 3 or more and > 5 mm.
- Incidence of adverse events [ Time Frame: Up to 730 days ]As assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
- Severity of adverse events [ Time Frame: Up to 730 days ]As assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
- Change in quality of life [ Time Frame: Baseline to up to 730 days ]As assessed using the Functional Assessment of Cancer Therapy-Prostate surveys. Functional Assessment of Cancer Therapy-Prostate is a validated quality of life survey specific for patients with prostate cancer.
- Change in quality of life [ Time Frame: Baseline to up to 730 days ]As assessed using the Short Form-36 survey. 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.
- Phosphatase and tensin homolog (PTEN) [ Time Frame: Baseline to up to 91 days ]Fluorescence in situ hybridization will be conducted to assess for genomic loss of the PTEN gene.
- PTEN immunohistochemistry [ Time Frame: Baseline to up to 91 days ]Immunohistochemistry will be conducted to assess for loss of PTEN protein expression.
- Alteration in MYC/chromosome 8q24 [ Time Frame: Baseline to up to 91 days ]Fluorescence in situ hybridization will be conducted to assess for genomic alterations (loss or amplification) of the MYC gene, which is located on chromosome 8q24.
- Tumor messenger ribonucleic acid expression profiling/risk classification [ Time Frame: Baseline to up to 91 days ]Messenger ribonucleic acid expression profiling will be conducted using the Decipher assay and/or ribonucleic acid-seq.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721979
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Michael Schweizer 206-606-6252 firstname.lastname@example.org|
|Principal Investigator: Michael Schweizer|
|Principal Investigator:||Michael Schweizer||Fred Hutch/University of Washington Cancer Consortium|