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

NCT02721979 | Terminated Phase 2 Results DMC FDA Drug

• 4 other identifiers: 9582NCI-2016-00221P30CA015704RG1716037
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

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

  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.

  At 90 days

Secondary Outcomes (11)

• Percentage of Patients Exiting Active Surveillance Due to Pathologic Reclassification

  At 2 years

• Percentage of Patients Exiting Active Surveillance for Any Reason

  At 2 years

• Percent of Men Undergoing Local Treatment

  At 2 years

• Local Treatment Free Survival

  Up to 730 days

• Prostate-specific Antigen Progression Rate

  At 2 years

Study Arms (1)

Treatment (apalutamide)

EXPERIMENTAL

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

Drug: Apalutamide; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Apalutamide DRUG

Given PO

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

Treatment (apalutamide)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (apalutamide)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (apalutamide)

Questionnaire Administration OTHER

Ancillary studies

Treatment (apalutamide)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have signed an informed consent document
• Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
• Written authorization for use and release of health and research study information has been obtained
• Life expectancy \>= 10 years (as determined by the treating physician)
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
• Histologically confirmed adenocarcinoma of the prostate as documented by a minimum 12 core prostate biopsy completed within 1-year of enrollment (note: most recent prostate biopsy must have demonstrated prostatic adenocarcinoma)
• Favorable risk prostate cancer as defined by:
• Very low-risk:
• Clinical stage T1c disease
• PSA density (PSAD) \< 0.15 ng/mL
• Gleason score 6
• =\< 2 core biopsies with =\< 50% involvement of any biopsy core with cancer, or unilateral disease =\< 2 core biopsies with any percentage involvement OR
• Low risk:
• Clinical stage =\< T2a
• PSA \< 15 ng/mL

You may not qualify if:

• Prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation therapy, brachytherapy)
• Prior use of ARN-509 (apalutamide)
• Have known allergies, hypersensitivity, or intolerance to ARN-509 (apalutamide) or its excipients
• Prior or ongoing systemic therapy for prostate cancer including, but not limited to:
• Hormonal therapy (e.g. leuprolide, goserelin, triptorelin)
• Cytochrome P450 (CYP)-17 inhibitors (e.g. abiraterone, ketoconazole)
• Antiandrogens (e.g. bicalutamide, nilutamide)
• Second generation antiandrogens (e.g. enzalutamide)
• Immunotherapy (e.g. sipuleucel-T, ipilimumab)
• Chemotherapy (e.g. docetaxel, cabazitaxel)
• Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
• History of any of the following:
• Seizure or known condition that may pre-dispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to registration, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
• Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, 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 registration
• Any condition that in the opinion of the investigator, would preclude participation in this study

Sponsors & Collaborators

• University of Washington: lead
• Janssen Scientific Affairs, LLC: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

apalutamide

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. Michael Schweizer
• Organization: University of Washington

schweize@uw.edu

(206) 606-6252

Study Officials

• Michael Schweizer

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Assistant Professor, Division of Medical Oncology

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 29, 2016
• Study Start: November 2, 2017
• Primary Completion: February 12, 2020
• Study Completion: November 30, 2021
• Last Updated: February 9, 2023
• Results First Posted: March 29, 2021

Record last verified: 2023-02

Locations

US (1)