← Back to Search

Hormone Therapy

Apalutamide + Abiraterone for Prostate Cancer (PANTHER Trial)

Phase 2
Waitlist Available
Led By Daniel J. George, MD
Research Sponsored by Daniel George, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A minimum of 4 weeks from any major surgery prior to start of study drug.
Karnofsky performance status ≥ 70
Must not have
Symptomatic Atrial Fibrillation, or other symptomatic cardiac arrhythmia
Prior treatment with abiraterone acetate, enzalutamide, apalutamide (ARN-509), galaterone (TOK-001), orteronel (TAK-700), or similar agent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 12 weeks, up to 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is a non-comparative pilot study of apalutamide and abiraterone acetate in African American and Caucasian men with mCRPC. The study's primary goal is to prospectively estimate the median PFS of the two groups of men. Secondary objectives include: PSA kinetics, radiographic assessments, safety and tolerability, and incidence of hypertension in the two populations.

Who is the study for?
This trial is for African American and Caucasian men with metastatic castrate-resistant prostate cancer. Participants must be over 18, have a life expectancy of at least 12 months, and be able to take oral medication. They should not have had certain previous treatments or conditions that could interfere with the study drugs or pose risks.
What is being tested?
The trial tests apalutamide, abiraterone acetate, and prednisone in treating prostate cancer. It's an open-label study where both African American and Caucasian men receive the same treatment to compare progression-free survival (PFS) rates, PSA response, radiographic assessments, safety, and tolerability.
What are the potential side effects?
Potential side effects include high blood pressure; liver issues; immune system changes leading to increased infection risk; gastrointestinal disorders affecting drug absorption; hormonal imbalances affecting adrenal or pituitary function; allergic reactions; seizures in predisposed individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
It has been at least 4 weeks since my last major surgery.
Select...
I am able to care for myself but may not be able to do active work.
Select...
I can take pills without crushing or chewing them and on an empty stomach.
Select...
My blood tests show normal white blood cells, platelets, and hemoglobin levels.
Select...
My kidney function is normal or only mildly reduced.
Select...
My prostate cancer is confirmed and not mainly neuroendocrine or small cell type.
Select...
I am continuing hormone therapy for my cancer, unless I've had both testicles surgically removed.
Select...
My prostate cancer is not responding to hormone therapy.
Select...
My PSA levels have been rising consistently.
Select...
I am a man aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have symptoms due to an irregular heartbeat.
Select...
I have previously been treated with specific prostate cancer medications.
Select...
I cannot take steroids like prednisone due to an infection or other medical condition.
Select...
My prostate cancer is of the small cell type.
Select...
I haven't had serious heart issues or blood clots in the last 6 months.
Select...
I am not taking strong medications that increase the breakdown of abiraterone.
Select...
I do not have an active infection like HIV, hepatitis, or chronic liver disease.
Select...
I take more than 5mg of prednisone or similar medication twice a day for a chronic condition.
Select...
I am allergic to abiraterone, apalutamide, prednisone, or their ingredients.
Select...
I have cancer spread to my liver or other organs causing symptoms.
Select...
I have cancer that has spread to my brain.
Select...
I have been treated with ketoconazole for my prostate cancer for more than a week.
Select...
I haven't taken azole anti-fungal drugs in the last 4 weeks.
Select...
My fasting blood sugar is 200 mg/dL or higher, indicating poorly controlled diabetes.
Select...
I have had issues with my pituitary or adrenal glands.
Select...
I have a condition or history that might increase my risk of seizures.
Select...
My liver is not working well (moderate to severe issues).
Select...
I have a cancer, other than non-melanoma skin cancer, with a high chance of returning within 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 12 weeks, up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 12 weeks, up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Median radiographic progression free survival (PFS)
Secondary study objectives
Change in PSA response
Change in radiologic response rates
Number of adverse events
+3 more

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389
98%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Dysphagia-esophageal radiation
8%
Hypoglycemia
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: CaucasianExperimental Treatment3 Interventions
Group II: African AmericanExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARN-509
2013
Completed Phase 2
~110
Abiraterone Acetate
2015
Completed Phase 4
~1880
Prednisone
2014
Completed Phase 4
~2500

Find a Location

Who is running the clinical trial?

Daniel George, MDLead Sponsor
7 Previous Clinical Trials
161 Total Patients Enrolled
3 Trials studying Prostate Cancer
84 Patients Enrolled for Prostate Cancer
Janssen Scientific Affairs, LLCIndustry Sponsor
164 Previous Clinical Trials
579,880 Total Patients Enrolled
10 Trials studying Prostate Cancer
864 Patients Enrolled for Prostate Cancer
Daniel J. George, MDPrincipal InvestigatorDuke Cancer Institute
2 Previous Clinical Trials
39 Total Patients Enrolled

Media Library

Abiraterone Acetate (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03098836 — Phase 2
Prostate Cancer Research Study Groups: African American, Caucasian
Prostate Cancer Clinical Trial 2023: Abiraterone Acetate Highlights & Side Effects. Trial Name: NCT03098836 — Phase 2
Abiraterone Acetate (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03098836 — Phase 2
~3 spots leftby Feb 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top