Prostate AdenocarcinomaPhase 2NCT02721979
Apalutamide in Treating Patients With Prostate Cancer Who Are in Active Surveillance
A Phase 2 study testing Apalutamide, Laboratory Biomarker Analysis and Quality-of-Life Assessment in people with Prostate Adenocarcinoma, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Apalutamide, Laboratory Biomarker Analysis and Quality-of-Life Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2017to 30 Nov 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
- Gleason score 6 OR
- Low-intermediate risk:
- Clinical stage T1c
- PSA < 15 ng/ml
- Gleason 3+4 present in =< 50% of one core/site as detected by systematic biopsy or MRI/transrectal ultrasound (TRUS) fusion guided biopsy
- Gleason 6 disease in all other cores / sites
- Willing and qualified for active surveillance at Johns Hopkins or the University of Washington
- Serum testosterone >= 150 ng/dL
- Able to swallow the study drugs whole as a tablet
- Hemoglobin >= 9.0 g/dL, (at screening), independent of transfusion and/or growth factors within 3 months prior to registration
- Platelet count >= 100,000 x 10^9/uL (at screening) independent of transfusion and/or growth factors within 3 months prior to registration
- Serum albumin >= 3.0 g/dL (at screening)
- Glomerular filtration rate (GFR) >= 45 mL/min (at screening)
- Serum potassium >= 3.5 mmol/L (at screening)
- Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (at screening) (note: in subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 × ULN (at screening)
- Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
- Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug; must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug
Who cannot join
- 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)
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- 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
- Current evidence of any of the following:
- Uncontrolled hypertension
- Gastrointestinal disorder affecting absorption
- Active infection (e.g. human immunodeficiency virus [HIV] or viral hepatitis) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
- Any condition that in the opinion of the investigator, would preclude participation in this study
- The use of drugs known to lower the seizure threshold, including: atypical antipsychotics (e.g. clozapine, olanzapine, risperidone, ziprasidone), bupropion, lithium, meperidine, pethidine, phenothiazine antipsychotics (e.g. chlorpromazine, mesoridazine, thioridazine), and tricyclic antidepressants (e.g. amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine)
- The use of strong CYP3A4 inhibitors, including: itraconazole, clarithromycin, erythromycin, diltiazem, verapamil, delavirdine, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit juice (or grapefruits)
- Note: If a patient is on a strong CYP3A4 inhibitor, they can be reconsidered for enrollment if they can safely stop said medication; a two week or 5 half-lives, whichever is longer, washout will be required prior to enrolling on study; subject may not resume medication while receiving apalutamide
- Strong CYP3A4 inducers, including: phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, efavirenz, tipranavir, St. John's wort
- Note: If a patient is on a strong CYP3A4 inhibitor, they can be reconsidered for enrollment if they can safely stop said medication; a two week or 5 half-lives, whichever is longer, washout will be required prior to enrolling on study; subject may not resume medication while receiving apalutamide
- Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: A Phase 2 Study of Apalutamide in Active Surveillance Patients
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.
Read the detailed description
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.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Apalutamide, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApalutamideDrug
Also called ARN 509, ARN-509, ARN509, JNJ 56021927
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (apalutamide) | Experimental | Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Apalutamide; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 90 days
Secondary outcomes (11)
Percentage of Patients Exiting Active Surveillance Due to Pathologic Reclassification
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.
Measured: At 2 years
Percentage of Patients Exiting Active Surveillance for Any Reason
Percentage of patients exiting active surveillance for any reason will be computed along with its 95% confidence interval.
Measured: At 2 years
Percent of Men Undergoing Local Treatment
Computed along with its 95% confidence interval.
Measured: At 2 years
Local Treatment Free Survival
Median treatment free survival will be estimated using Kaplan-Meier methods and 95% confidence interval will be calculated
Measured: Up to 730 days
Prostate-specific Antigen Progression Rate
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.
Measured: At 2 years
Prostate-specific Antigen Progression Free Survival as Defined by the Prostate Cancer Working Group 2 Criteria
Prostate-specific antigen progression free survival will be estimated using Kaplan-Meier methods and 95% confidence interval will be estimated using Greenwood's formula.
Measured: At 2 years
Change in Radiographic Disappearance of Magnetic Resonance Imaging Detectable Prostate Cancer
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.
Measured: Baseline to up to 90 days
Change in Quality of Life: FACT-P Assessment
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.
Measured: Baseline compared to 730 days
Change in Quality of Life: SF-36 Physical Functioning
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.
Measured: Baseline compared to 730 days
Change in Quality of Life: SF-36 Energy/Fatigue
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.
Measured: Baseline compared to 730 days
Change in Quality of Life: SF-36 Emotional Well Being
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.
Measured: Baseline compared to 730 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study start2 Nov 2017
- Primary completion12 Feb 2020
- Study completion30 Nov 2021
Why it stopped: Terminated due to slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Michael Schweizer, University of Washington
- Investigators
- Michael Schweizer, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721979
- Sponsor's protocol ID
- 9582
- Other IDs
- NCI-2016-00221, 9582, P30CA015704, RG1716037
- Status last verified
- Feb 2023
- First submitted
- 11 Mar 2016
- Last updated
- 9 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Apalutamide in Active Surveillance Patients
- ClinicalTrials.gov ID
- NCT02721979
- Acronym / sponsor ID
- 9582
- Conditions
- Prostate Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to slow accrual
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC, National Cancer Institute (NCI)
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Posted 29 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (apalutamide) | Experimental | Drug: Apalutamide, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- 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
Key exclusion criteria (26 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApalutamideAlso: ARN 509, ARN-509, ARN509, JNJ 56021927Given PO | Drug | Treatment (apalutamide) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (apalutamide) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (apalutamide) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (apalutamide) |
Primary outcome
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.
11 secondary outcomes
Percentage of Patients Exiting Active Surveillance Due to Pathologic Reclassification
Time frame: At 2 years
Percentage of Patients Exiting Active Surveillance for Any Reason
Time frame: At 2 years
Percent of Men Undergoing Local Treatment
Time frame: At 2 years
Local Treatment Free Survival
Time frame: Up to 730 days
Prostate-specific Antigen Progression Rate
Time frame: At 2 years
Prostate-specific Antigen Progression Free Survival as Defined by the Prostate Cancer Working Group 2 Criteria
Time frame: At 2 years
Change in Radiographic Disappearance of Magnetic Resonance Imaging Detectable Prostate Cancer
Time frame: Baseline to up to 90 days
Change in Quality of Life: FACT-P Assessment
Time frame: Baseline compared to 730 days
Change in Quality of Life: SF-36 Physical Functioning
Time frame: Baseline compared to 730 days
Change in Quality of Life: SF-36 Energy/Fatigue
Time frame: Baseline compared to 730 days
Change in Quality of Life: SF-36 Emotional Well Being
Time frame: Baseline compared to 730 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Schweizer principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apalutamide, Laboratory Biomarker Analysis and Quality-of-Life Assessment in people with Prostate Adenocarcinoma, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative (i.e. no Residual Carcinoma) Site Directed and Systematic Prostate Biopsy Rate (time frame: At 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.